dimarts, 31 d’octubre del 2017

OmniLife Science launches OmniBotics knee replacement active spacer

OmniLife ScienceRobotic knee surgery platform developer OmniLife Science said today it began testing on its OmniBotics active spacer robotic tissue balancing device at 3 US sites after having won FDA 510(k) clearance in September.

The Raynham, Mass.-based company said its OmniBotics active spacer is designed to allow surgeons performing total knee surgeries to quantitatively manage the soft tissue envelope during the procedure, and can be combined with the company’s OmniBotics system for a customized procedure from a skeletal and tissue-based perspective.

Read the whole story on our sister site, The Robot Report

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NeuroMetrix closes $4m private placement

NeuroMetrix

NeuroMetrix (NSDQ:NURO) said today it closed a $3.5 private placement round of Series F convertible preferred stock with funds slated to support continued commercialization of its Quell device.

The Waltham, Mass.-based ocmpany floated a total of 3,500 Series F convertable shares at $1,000 per share. Shares sold in the round are convertible into 1.3 million shares of common stock at $2.63 per share, according to the company.

The closing was the 2nd and final tranche of a $7 million private placement equity offering with an institutional investor which was originally reported in July. NeuroMetrix said the company received shareholder approval for the 2nd tranche at a special meeting of shareholders last month.

A total of 7,000 Series F shares were issued in the private placement for total proceeds of $7 million.

In May, NeuroMetrix said it would engage in a 1-for-8 reverse stock split as it looks to satisfy the $1 minimum bid price requirement for the NASDAQ capital market.

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BRH Medical wins FDA nod for electro and ultrasound wound treatment system

BRH Medical

Medical device developer BRH Medical said today it won FDA 510(k) clearance for its BRH-A2 device designed to reduce pain and improve deep wound healing through the use of ultrasound and electric fields.

The Israel-based company’s BRH-A2 device is designed to engage and stimulate the wound from below the wound bed using both an ultrasound and electric field system which varies in frequency and intensity over the course of the treatment.

“It has always been my desire to develop a product that would truly help cure people. Our grateful patients are proof of the effectiveness of the technology,” CTO & device inventor Ilan Feferberg said in prepared remarks.

The portable wound treatment system is designed to be used together “with any treatment modality,” BRH Medical said.

“FDA clearance for the BRH-A2 represents an important milestone for our company and provides an important key to opening the huge potential of the market in the United States for our product. We are now exploring the most efficient way to penetrate the market, and are currently focusing on identifying strategic partnerships. The market for products that ease the pain of chronic wounds is large and growing. Our vision is to become the gold standard for treatment of chronic wounds of all kinds, including pressure wounds, diabetic leg wounds and wounds caused as a result of ischemia,” CEO Motti Oderberg said in a prepared statement.

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Study: Glooko’s mobile app boosts glycemic control in patients with Type II diabetes

GlookoGlooko touted data today from a feasibility study evaluating the impact of its mobile insulin dosing system for people with Type II diabetes who are taking long-acting insulin.

The Mountain View, Calif.-based company said it hoped to better understand the extent to which its system can make appropriate insulin titration adjustments and improve a patient’s glycemic status.

Get the full story at our sister site, Drug Delivery Business News.

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Pfizer posts Street-beating Q3, raises full-year earnings forecast

PfizerShares in Pfizer (NYSE:PFE) fell slightly today even though the pharmaceutical giant beat expectations on Wall Street with its third quarter results.

The New York-based company posted profits of $2.84 billion, or 47¢ per share, on sales of $13.17 billion, for sales growth of 1% compared with last year’s third quarter results.

Get the full story at our sister site, Drug Delivery Business News.

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FDA clears Abbott’s Alinity diagnostic analyzers

Abbott logo

Abbott (NYSE:ABT) said today it won FDA 510(k) clearance for its Alinity instruments for clinical chemistry and immunoassay diagnostics.

The newly launched ci-series of Alinity devices includes improvements such as smaller footprints, improved workflow capabilities and reduced wait times and simplified designs for error proofing and enhanced usability, the company said.

“Healthcare systems across the United States are under pressure to deliver better care for patients. Labs and healthcare systems are looking for complete solutions that help them operate more efficiently while contributing to better clinical decision making and helping improve patient outcomes. FDA clearance is a key first step in bringing this important innovation to our U.S. customers as we work to gain approval for the full Alinity portfolio of instruments and assays,” Abbott diagnostic products exec VP Brian Blaser said in a prepared statement.

Abbott said its Alinity system includes the Alinity c clinical chemistry system and the Alinity i immunoassay system, both of which can operate individually or work together as an integrated Alinity ci-series unit.

“Alinity ci was designed using a different approach. We went beyond traditional market research and spent countless hours with our customers, listening to their challenges and observing how they work. With customer insights as our roadmap, the Alinity ci is engineered to simplify diagnostic testing while ensuring speed, accuracy and performance,” immunoassay and clinical chemistry R&D VP John Frels said in prepared remarks.

The company said that in addition to the instrument clearance, it has also obtained clearance for several tests on the system with a “comprehensive menu of tests expected to be available within a year of launch,” according to a press release.

Yesterday, Abbott said it won CE Mark approval in the European Union for its next-generation drug-eluting stent, the Xience Sierra.

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BioGeneration Ventures closes $95m medtech fund

BGV

BioGeneration Ventures said today its BGV III fund raised $95.4 million (EU €82 million) in its final closing, looking to focus on therapeutics, medical devices and diagnostics within the European Union.

Investors joining the funding, which surpassed its $58.3 million (EU €50 million) including Bristol-Myers Squibb, Johnson & Johnson Innovation, the incubation arm of healthcare giant Johnson & Johnson (NYSE:JNJ), and private equity investors Schroder Adveq and the MAN Pension Trust, BGV said.

“Over the last years, BGV has proven that investing in early stage companies is critical in developing innovative science to meet patients’ needs; it can be financially very attractive as well. We believe that support and close collaboration from Bristol-Myers Squibb and JJDC illustrate the increasing interest in early stage innovation. This also demonstrates the unique position that BGV has reached in this arena,” BGV managing partner Edward van Wezel said in a prepared statement.

The fund has already made five investments in related companies including German immuno-oncology group Catalym, and Dutch companies Escalier Biosciences, Scenic Biotech, Varmx and Mellon Medical.

“Bristol-Myers Squibb recognizes the potential of early stage innovations emerging from leading scientific groups in the European biotech scene.  We are committed to working with VC investors such as BGV who can identify the investment opportunities with the most potential to deliver transformational medicines,” Bristol-Myers Squibb biz dev head Paul Biondi said in a press release.

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Agile Therapeutics touts late-stage trial for once-weekly contraceptive patch

Agile TherapeuticsAgile Therapeutics (NSDQ:AGRX) touted data today from a Phase III trial of its once-weekly, low-dose hormonal contraceptive patch, Twirla.

The study showed that women experienced mean decreases in length of bleeding and spotting episodes, the Princeton, N.J.-based company reported.

Get the full story at our sister site, Drug Delivery Business News.

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TCT 2017: OrbusNeich’s dual therapy stent non-inferior to Abbott’s Xience DES in 1-year follow-up

OrbusNeichOrbusNeich touted results today from a pivotal registration study comparing its Combo dual therapy stent with Abbott‘s (NYSE:ABT) Xience stent in patients with ischemic heart disease.

The trial is designed to evaluate the effectiveness of OrbusNeich’s combined endothelial progenitor cell capture and drug-eluting stent. The data showed that the device is non-inferior to Abbott’s drug-eluting stent after 12 months, with a 7% rate of target vessel failure in the Combo group and 4.2% in the Xience group.

Get the full story at our sister site, Drug Delivery Business News.

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LumiThera raises $6m in Series B

LumiThera

LumiThera said today it raised $5.5 million in a Series B round of financing to support the development of its LT-300 device designed for treating dry age-related macular degeneration.

Proceeds from the round will support pursuit of regulatory clearance for the LT-300 device outside the US, including CE Mark approval in the European Union and additional clinical and commercial activities, the Seattle-based company said.

“We are pleased with the investor interest in the company and have oversubscribed the Series B round. This is an exciting time for the company and the infusion of new capital will allow us to execute on our multi-center clinical trials and initial OUS commercialization activities,” prez & CEO Clark Tedford said in a prepared statement.

The round was led by WaterStone Capital and joined by RPR Venture, the company said. As part of the round, WaterStone Capital founding partner Yigang Yang will join the company’s board of directors.

“WaterStone is very excited to be part of the LumiThera team and looks forward to helping in the global commercialization of the PBM technology for ocular disease,” Yang said in a press release.

LumiThera said it is currently engaged in a 30-patient prospective, randomized, double masked clinical trial exploring the use of the LumiThera LT-300 light delivery system.

“LumiThera has made significant strides in developing a novel treatment for a debilitating eye disease. Patients currently have limited options and vision loss is a growing global unmet medical need and the focus of our PBM platform technology,” board member Arthur Taylor said in a prepared release.

Last March, LumiThera said it won Health Canada approval for its Lightsite clinical trial examining the effect of its non-invasive photobiomodulation treatment in patients with age-related macular degeneration.

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Titan Medical adds to $3m private placement, plus $7m from warrants exercise

Titan Medical SportTitan Medical (TSX:TMD) said today it added an approximate $300,000 to a private placement round that closed earlier this month alongside raising $6.5 million (CDN $8.4 million) from exercising share purchase warrants.

The Toronto-based robotic surgical platform developer said that it raised a total of $2.6 million (CDN $3.3 million) through the placement of 13.4 million shares of its stock at 19¢ per share, up from a previously reported $2.3 million (CDN $2.9 million) it announced when the round closed on October 20.

Read the whole story on our sister site, The Robot Report

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TCT 2017: Medtronic touts 1-year intermediate data for Evolut R TAVR

Medtronic's CoreValve Evolut R TAVRMedtronic (NYSE:MDT) is touting data from a pair of studies of intermediate-risk patients implanted with its Evolut R replacement heart valve, presented today at the Transcatheter Cardiovascular Therapeutics annual meeting in Denver.

Fridley, Minn.-based Medtronic presented results from its Surtavi trial and Evolut R Forward real-world study of its next-generation transcatheter aortic valve replacement today at TCT.

One-year data from Surtavi, comparing the Evolut R and CoreValve devices with open heart surgery, showed a 7.8% mortality rate for the TAVR arm, compared with 8.5% for the open surgery arm. A sub-group analysis showed a 100% survival rate and a 1.5% all-stroke rate and a 0.4% rate of disabling stroke at 30 days, the company said.

“With its supra-annular and self-expanding design, the Evolut TAVR platform is well-suited to deliver excellent valve performance for intermediate risk patients who are often considered to be more active than high- or extreme-risk patients,” Dr. Nicolas Van Mieghem, of Rotterdam’s Erasmus Medical Center, said in prepared remarks. “As new clinical data are gathered for this patient population, we continue to see the exceptional clinical benefits this self-expanding valve provides as a minimally-invasive treatment alternative to surgery.”

Another sub-analysis, of patients stratified according to predicted mortality risk of STS-PROM less than 3%, showed a 1.5% rate of all-cause mortality or disabling stroke at 1 year, compared with 6.5% for the open surgery cohort.

Results from a subset of 257 patients in the Evolut R Forward study, also stratified with an STS PROM of less than 3%, showed an all-cause mortality rate of 2.0% and a disabling stroke rate of 1.2% at 30 days.

“As we continue to build our growing body of evidence to support the Evolut TAVR platform in intermediate-risk patients, the Surtavi and Forward clinical programs further support our efforts to expand TAVR access to a broader patient population,” structural heart medical affairs VP Dr. Pieter Kappetein said. “We look forward to working with heart teams around the globe to continue our commitment to evaluating TAVR performance in healthier patients.”

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Wright Medical launches long-term study for Infinity total ankle

Wright MedicalWright Medical (NSDQ:WMGI) said today that it launched a long-term study of the Infinity total ankle replacement device it introduced three years ago.

The 10-year follow-up study of 200 patients aims to evaluate survivorship and to characterize improvements in patient-reported outcomes, Memphis-based Wright said.

At its June 2014 debut, the company touted Infinity as a solution for both primary ankle arthroplasties and secondary or revision surgeries. The device is designed to be compatible with Wright’s Inbone II talar components and the Prophecy pre-operative alignment system.

“With the growing popularity and increasing demand for alternatives to ankle fusion, there is a real need for quality, forward-looking studies that document the results of total ankle replacement surgery to further validate our clinical decision making,” primary investigator Dr. Andrew Murphy, of the Campbell Clinic in Memphis, said in prepared remarks. “Wright Medical is leading the way in this progress, and we expect to glean valuable data from this study of the Infinity total ankle system.”

Wright also said the 500-patient post-market study in the U.K. it launched last year, also designed to evaluate 10-year survivorship and patient-reported outcomes, enrolled 100 patients as of the third quarter.

“It is increasingly important for industry and clinicians to work together to provide patients, colleagues and healthcare providers with robust clinical evidence to support new systems,” added chief investigator Dr. David Townshend of the Northumbria NHS Healthcare Trust. “We are delighted that Wright has taken the opportunity to sponsor a high-quality, multi-center follow-up study in the United Kingdom to evaluate the Infinity total ankle replacement, and we look forward to sharing these results.”

“The undertaking of both the US and UK post-market clinical studies are a testament to Wright’s ongoing commitment to foot and ankle surgeons and their patients,” global clinical affairs VP Ann Burgess said. “By collecting longitudinal patient outcomes through real-world experience of non-design surgeons at centers of excellence around the globe, Wright will generate important information that will drive the continued evolution of the treatment and technologies addressing end-stage ankle arthritis for years to come.”

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Procept BioRobotics launches AquaBeam trial in France

Procept BioRoboticsProcept BioRobotics said today that it launched a clinical trial aimed at winning reimbursement approval in France for its AquaBeam prostate treatment.

Redwood Shores, Calif.-based Procept said the 30-patient Francais Water study is designed to evaluate the safety and effectiveness of prostate ablation via waterjet in treating benign prostate hyperplasia in men aged 45 to 80. The primary outcome is total change in International Prostate Symptom score at 6 months, with a final data collection slated for August 2018, according to ClinicalTrials.gov.

Get the full story at our sister site, The Robot Report.

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Elixir Medical unveils ‘bioadaptive’ metallic drug-eluting stent at TCT 2017

Elixir Medical DynamXInterventional cardiologists have used stents to keep the heart’s coronary arteries open for decades. Transitioning from bare-metal stents to drug-eluting stents in the early 2000s brought tremendous benefits for patients.

“But over the last 10 years, the technological progress and meaningful clinical improvements have plateaued,” Elixir Medical CEO Motasim Sirhan told Drug Delivery Business News.

“When you stent an artery today, you actually cage it and by caging it you are inhibiting the normal pulsatility of the artery and inhibiting its built-in mechanism of adaptive remodeling intended to slow disease progression and clinical events,” he explained.

So Sirhan’s 65-person company set out to create a device that has the therapeutic benefit of a drug-eluting stent, but also helps the vessel resume its natural healing process. And last night at the annual Transcatheter Cardiovascular Therapeutics meeting, Elixir Medical unveiled what the company is touting as a new class of drug-eluting stents.

Get the full story at our sister site, Drug Delivery Business News.

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Surgeon sues J&J’s DePuy in royalties dispute

DePuy Synthes Spine's MountaineerA surgeon who helped Johnson subsidiary DePuy Synthes Spine develop instruments and implants for spine procedures wants a Massachusetts federal court to overturn an arbitrator’s ruling that the company doesn’t owe royalties on the products, according to a lawsuit filed last week in the Bay State.

Dr. Carl Lauryssen and his company, Jordan Consulting, helped develop the Mountaineer OCT spinal system and thethe C1 drill guide for occipito-cervico-thoracic spinal fusion procedures. The parties inked the development deal in 2003, but by November 2014 the arrangement had soured, leading Lauryssen and Jordan to file for arbitration. They alleged that DePuy breached the contract by underpaying royalties owed on the Mountaineer system and failing to pay royalties for the C1 drill guide, according to an Oct. 27 complaint filed with the U.S. District Court for Massachusetts.

DePuy’s counterclaim alleged that the royalties arrangement ended in March 2010 and sought to recoup royalties paid to Jordan and Lauryssen. Last month the arbitrator denied all of Jordan and Lauryssen’s claims and agreed that the royalty deal expired in March 2010, but denied DePuy’s bid to recoup any royalties, according to the complaint.

“Although the arbitrator’s final award stated that it denied Jordan’s counts for breach of contract, the final award clearly stated that Jordan was contractually entitled to patent royalties when the Mountaineer screws and rods were used with the cross-connector during the period November 4, 2008 to March 2010. It was undisputed that Jordan had not been paid patent-based royalties on said items when used with a cross-connector,” the plaintiffs alleged. “Notwithstanding the foregoing, the arbitrator also denied Jordan’s request for an accounting that would have required DePuy to calculate the amount of DePuy’s underpayment of royalties and did not present Jordan with any further opportunity to address the damages resulting from DePuy’s breach of contact.”

The plaintiffs asked the Massachusetts court to vacate the arbitrator’s ruling and remand the case for another round of mediation, according to the complaint.

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Philips highlights wearable tech in healthcare with pitch competition

Philips wearables competitionEntrepreneurs joined Royal Philips (NYSE:PHG) executives and other players in the medical device industry last week at Philips’ Wearables & Chronic Care Challenge to tout their novel wearable technology and compete for a chance to win $10,000.

It was the second time that Philips has hosted the event, in-line with the two-year anniversary of the company’s connected sensing unit, led by Ravi Kuppuraj.

“We’re almost like a little startup within Philips so we bring that startup mentality and attitude, enthusiasm, speed and lean principles,” he told MassDevice.com.

Philips’ Connected Sensing unit was put together to help bring wearable technology to mainstream healthcare, Kuppuraj said. Lately, the team has been specifically focused on designing wearable technology for the general ward.

“Beyond the ICUs and the CCUs, one of the interesting things we found as we talked to our customers was all the challenges and the unmet need in the general wards and general care areas of the hospital,” he said.

General wards are getting more crowded, Kuppuraj explained, and there isn’t always a nurse for every patient. And patients in a general ward are usually mobile, unlike those in the ICU.

After talking with healthcare providers, the connected sensing venture team used a four-pronged process to bring to market a wearable that could be useful in the general ward. They evaluated the patient’s experience, associated outcomes, cost-effectiveness and the caregiver’s experience, eventually landing on a wearable biosensor that can remotely monitor a patient’s vital signs and warn caregivers when it detects signs of deterioration.

Philips wearable competition winner“It’s easy to wear – you just put it on and forget about. It seamlessly and continuously transmits the key vital signs from the patient, wirelessly and continuously to the back-end Philips system, where that data is crunched into some kind of an early warning score,” Kuppuraj said. “And then just when it’s needed, that particular piece of information is then relayed to the nurse or the caregiver on duty.

So it’s a lot less expensive than a monitor, it’s a lot more comfortable for a patient to just wear a sensor and be as normal as they can be in a general ward.”

These factors – patient experience, outcomes, cost and healthcare provider experience – were on the judges’ minds last week as they evaluated pitches from six finalists vying for an investment from Philips.

The groups touted technology ranging from a non-invasive white blood cell monitor to a wearable thermometer. But the finalist that won first place, and the $10,000, was Nanowear – a New York-based company that has created a textile-based, wearable nanosensor designed to help patients manage heart disease.

In December last year, Nanowear won 510(k) clearance from the FDA for its first product, SimplECG. The garment continuously collects multi-channel ECG, heart rate and respiratory rate data and sends it to a web-based portal for review by a physician.

Second place went to Raiing Medical and its iThermonitor, earning the company a $5,000 investment. The company’s wearable thermometer is designed to help parents monitor their child’s fever remotely using a mobile app.

Third place was a tie between Bold Diagnostics, a group with a wearable diagnostic for hypertension, and Leuko Labs, which has created a wearable white blood cell monitor.

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Orthofix’s Q3 profits plunge

OrthoFixThird-quarter profits for Orthofix (NSDQ:OFIX) plunged some 65% compared with the same period last year on increased income tax expenses, but the orthopedics company raised its 2017 sales outlook and increased the high end of its earnings forecast.

Lewisville, Texas-based Orthofix posted profits of $3.5 million, or 19¢ per share, on sales of $105.2 million for the three months ended Sept. 30, for a bottom-line plunge of -65.1% on sales growth of 6.9% compared with Q3 2016. Adjusted to exclude one-time items, earnings per share were 42¢, 4¢ ahead of the consensus forecast on Wall Street.

“We continue to execute on our strategy of increasing the organic growth and profitability of each of our four strategic business units while rationalizing corporate costs in all areas. This has resulted in an accelerating sales growth rate each quarter thus far this year, and positioned us for solid mid-single digit organic revenue growth and the opportunity for meaningful margin expansion in the years to come,” president & CEO Brad Mason said in prepared remarks.

CFO Doug Rice told analysts during a conference call that income tax expenses for the quarter were 65% of income before taxes, compared with -14% for the prior year’s quarter.

“This year-over-year increase in our rate was driven by accruals for uncertain tax positions in the current quarter as well as a one-time tax benefit in the third quarter of 2016 related to a change in estimate for share based compensation that did not recur this year,” Rice explained, according to a Seeking Alpha transcript.

Mason said the impact of Hurricane Maria in Puerto Rico is likely to mean a -$500,000 sales hit during fourth quarter “until such time as medical procedures begin to ramp back to normal volumes.”

“Based on this we are planning for little to no sales in Puerto Rico for the next four to six quarters,” he said.

Orthofix said it now expects to post adjusted EPS of $1.54 to $1.63 for the full year, compared with $1.54 to $1.60 previously. Revenues are pegged at $428 million to $431 million, up from $422 million to $425 million previously.

OFIX shares closed up 0.9% at $49.85 apiece yesterday.

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FDA launches new market pathway for breakthrough medical devices

Emergo GroupBy Stewart Eisenhart, Emergo Group

The US Food and Drug Administration plans to establish a new market authorization pathway for innovative and breakthrough medical devices that would replace current priority review programs including the Expedited Access Pathway (EAP) and the Priority Review Program.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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dilluns, 30 d’octubre del 2017

Inscope Medical launches suction-equipped laryngoscope

Inscope Medical Solutions

Inscope Medical Solutions said today it launched its Inscope Direct laryngoscope with integrated, controllable suction, touting it as the 1st of its kind.

The Inscope Direct device is designed to eliminate the need to move between yankauer suction and the endotracheal tube while securing the airway, the Washington D.C.-based company said.

“Using the Inscope Direct is addicting. It’s easy to use and the controllable suction in the mouth throughout procedures keeps the right hand free to focus on passing the endotracheal tube Being able to easily suction while starting and throughout the intubation process is a game changer – it makes the first view a clear view, simplifying direct laryngoscopy every time,” co-founder & chief medical officer Dr. Mary Mallory said in a press release.

The newly launched device’s suction is designed to remove secretions to allow for a clear view of the vocal cords for easier placement of the endotracheal tube, and features a built in LED light source and anti-clog design. The system connects to standard suction tubing and is compatible with wall suction and powered portable suction, the company said.

“Inscope Direct was born out of a real-life need following an incident where a founding physician had to treat a patient with life-threatening injuries, but struggled through the intubation process by juggling multiple pieces of equipment to clear the airway and pass the breathing tube. Every second is critical in emergency situations, and we knew there just had to be a better way. We are thrilled to bring the Inscope Direct to market – not only for emergency intubations, but also planned intubations when secretions can unexpectedly become an issue. Now with the Inscope Direct, clinicians have at their disposal a tool that makes the intubation process more efficient and can improve outcomes for patients,” co-founder & CEO Maggie Galloway said in a prepared statement.

Inscope Medical said it is currently developing a video laryngoscope using the integrated suction technology.

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Vascular Dynamics touts 6-month interim data from MobiusHD trial

Vascular Dynamics

Vascular Dynamics today released interim results from the 1st-in-human trial of its MobiusHD implant designed for treating resistant hypertension, touting a significant reduction in ambulatory systolic blood pressure at 6-months.

The MobiusHD device is designed to help regulate blood pressure using electrodes implanted in the carotid artery to stimulate baroreceptors and increase the body’s natural response to lower blood pressure through vasodilation.

Interim results from the Calm-FIM study indicated an average ambulatory systolic blood pressure reduction of more than 19 mmHg from baseline at 6 months. Data also indicated that 89% of the 42 patients in the trial had a greater than 10 mmHg drop in office systolic blood pressure or 5 mmHg or more in 24-hour ambulatory systolic blood pressure.

Other results also indicated a 16.3% reduction in use of antihypertensive medication, the Mountain View, Calif.-based company said.

“These data provide the backbone for our understanding of the enormous potential of this approach to managing resistant hypertension, which is the term for blood pressure that remains too high despite the use of as many as three or more antihypertensive drugs. The impressive results in an open label setting underscore the value of initiating the pivotal, sham-controlled trial to determine to what extent we can replicate, or even improve upon the outcomes,” US arm principal investigator Dr. Mark Bates of Charleston’s West Virginia University said in a press release.

Vascular Dynamics said it has also launched a pivotal, sham-controlled trial of the device in the US and Europe.

“We are encouraged with the results we’ve seen to date with the MobiusHD Calm-FIM studies in the US and the EU. Earlier this year the European arm results were published in The Lancet and we look forward to the publication of the combined data next year. We believe that this treatment represents a paradigm shift in treating resistant hypertension in the clinic and we look forward to continuing to generate data in the Calm 2 pivotal trial,” CEO Robert Stern said in a prepared statement.

In late August, Vascular Dynamics said the FDA approved an investigational device exemption for a clinical trial of its MobiusHD device for treating resistant hypertension.

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TCT 2017: Abbott’s Xience coronary stent helps patients feel better faster than open-heart surgery

Abbott logoAbbott (NYSE:ABT) reported today that patients who were treated with the company’s Xience coronary stent for left-main coronary artery disease felt better faster compared to patients who had open-heart surgery.

The data were presented at this year’s Transcatheter Cardiovascular Therapeutics meeting during a late-breaking session.

“For any treatment, it’s important to not only consider clinical outcomes such as recurrent heart attacks or stroke, but also to consider the effect of the treatment on a patient’s quality of life,” study investigator Dr. Suzanne Baron said in prepared remarks.

Get the full story at our sister site, Drug Delivery Business News.

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FDA Guidance: Use of real-world evidence to support regulatory decision-making for medical devices

imarcblog1030

by Lisa Wickert/IMARC Research

On Aug. 31, the FDA issued the finalized guidance manual for medical device companies’ use of real-world evidence (RWE) and real-world data (RWD) to gain FDA approval for their medical devices. The FDA draft guidance was originally issued on July 27, 2016 to the public to give those in the medical device industry an opportunity to provide comments prior to finalization. Additionally, the FDA hosted a webinar on the topic to provide additional guidance on October 10, 2017. Per the FDA, the guidance was issued “to clarify how we evaluate RWD to determine whether it may be sufficiently relevant and reliable to generate the types of RWE that can be used in FDA regulatory decision-making for medical devices.”  This includes whether or not FDA will require an Investigational Device Exemption (IDE) to determine the safety and effectiveness of a device.

This FDA guidance is applicable to all devices as defined under section 201(h) of the Federal Food, Drug, and Cosmetic Act. However, this guidance does not apply to the use of non-clinical data, adverse events reports, secondary use of clinical trial data, or systemic literature reviews.

RWD has the potential to facilitate FDA regulatory decisions in the interest of promoting public health and technological advancements while still protecting human safety. During the lifecycle of a medical device, there is a substantial amount of data that is collected over the course of patient treatment and management outside the scope of a clinical trial setting. Furthermore, it is quite common for devices to be used in a clinical setting for indications outside the approved use. As such, a large amount of data is generated throughout the lifecycle of a medical device that can impact patient outcomes.  

The guidance is as the name implies; the FDA does not mandate a certain type of RWD nor does it specify a preferred type of RWD. The characteristics, type, and relevance of the RWD will be evaluated case-by-case. Thus, it is up to the sponsor to determine what type(s) of RWD is most applicable and should select appropriate RWD sources to address their specific regulatory questions.  It is the responsibility of the FDA to deem the RWD collected to support RWE of sufficient quality for regulatory use.

Do you have experience with the collection or analysis of RWD to support RWE?  Has this led to a regulatory decision by FDA?

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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Mauna Kea touts Cellvizio pancreatic cyst diagnosis study data

Mauna Kea

Mauna Kea (ENT:MKEA) today released data from a study exploring the use of the company’s Cellvizio system to diagnose pancreatic cysts, touting improved diagnoses and patient management.

Results from the trial were presented at the United European gastroenterology Week 2017 meeting, the Paris-based company said.

The Cellvizio device is designed for use in a variety of surgical procedures, providing real time visualization at the microscopic level. The system allows the operating physician to visualize the internal microstructure of tissue in real time during ureteroscopic and cytoscopic procedures, Mauna Kea said.

Data in the Contact study came from 217 patients at 5 clinics in France, the company said, and showed that the use of Cellvizio altered 30% of diagnoses and improved diagnostic inter-observer agreement from 0.45 to 0.76.

Use of the device also reportedly changed 28% of patient management strategies, prevented 42% of patients with benign cysts from undergoing continued surveillance and reversed choices between surveillance and surgery in 15% of pre-malignant lesions.

“Previous results from the contact study already validated the very high sensitivity and specificity of endomicroscopy for the diagnosis pancreatic cystic lesions, which remained until now a major diagnostic issue for clinicians. With these new data from the Contact study, we have shown that the use of Cellvizio allows clinicians to alter, with a high confidence level, their treatment decisions. Overall, these results from the Contact study continue to support the recognition of endomicroscopy as an integral part of the standard of care in patients with pancreatic cystic lesions,” Dr. Bertrand Napoleon, who presented the study results, said in a press release.

Mauna Kea touted a number of other presentations at the conference featuring its Cellvizio technology, including the use of it to detect colonic mucosa micro-inflammation and Chron’s disease.

“This year at UEGW we are highlighting the ability of needle-based confocal laser endomicroscopy with Cellvizio to address diagnostic uncertainties in pancreatic cysts, which is a well-known and hard-to-achieve medical challenge. This study demonstrates the potential benefit of using Cellvizio as a standard of care for this major application,” CEO Sacha Loiseau said in a prepared statement.

Last month, Cook Medical said its urology business launched the Cellvizio system with a deal to distribute the device globally.

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Stryker launches value-based care service for orthopedic docs

Stryker

Stryker (NYSE:SYK) said today that its Performance Solutions division launched the Practice Excellence program designed to help orthopedic practices improve profitability, efficiency and quality outcomes.

The newly launched program includes a full financial and operational analysis and report on the physician’s practice looking for areas of improvement followed by a custom tailored plan developed by the team.

“Physician groups are under tremendous pressure to reduce costs and grow their practices. We are committed to helping healthcare professionals succeed from every angle. With the addition of the Practice Excellence program to our portfolio, we have an even broader spectrum of data intelligence and customizable solutions to help our customers determine actionable insights that are key to building a strong future in this uncertain healthcare environment,” Performance Solutions VP Brian McCrone said in a prepared statement.

Plans include a focus on revenue cycle management, practice redesign including workflow mapping and optimized patient visit management and ongoing data analytics to drive continued informed decision making, Stryker said.

“Practice management is increasingly more difficult due to the administrative burden of managing insurers, contracts, government reporting requirements and patient demands. Through the Practice Excellence program, physician groups can tap into our team’s expertise in practice management, finance, and healthcare policy and reform, among other disciplines, to help sharpen their competitive edge and work toward becoming more profitable,” Performance Solutions medical director Dr. Richard Conn said in a press release.

Late last week, Stryker released 3rd quarter earnings that beat the Street in both earnings per share and revenue.

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Mortara founder donates $25m to UCSF to study alarm fatigue

heart - generic

Mortara Instrument founder and electrocardiogram innovator Dr. David Mortara donated $25 million to the University of California San Francisco’s School of Nursing to support research looking to reduce “alarm fatigue” and improve patient care and safety.

The contribution, which UCSF said is the largest to date for the school, will support the creation of a new Center for Physiologic Research. The newly created center will support the efforts with the creation of a large ECG database aiming to identify predictors of adverse patient outcomes, reduce false alarm rates and improve ECG monitors.

Funds will also support hiring of new faculty and students and interdisciplinary research efforts with UCSF Health.

“We are very grateful to David Mortara for his tremendous contribution in creating the innovative Center for Physiologic Research in the UCSF School of Nursing. The school is a national leader in the study of alarm fatigue and ECG monitoring, and this gift will significantly advance these efforts to further improve patient care, one of UCSF’s primary mission,” UCSF chancellor Sam Hawgood said in a press release.

Mortara founded cardiology tech and ECG dev Mortara Instrument in 1982 after spending a number of years at Marquette Electronics, contributing to development in simultaneous 12-lead ECG acquisition and interpretation which is used as a base for most electrocardiogram technology in use today.

“I’ve seen for too long that there is a vendor world of research and a separate medical world of research, and they don’t cross very well. The long-term vision of this center is to be a bridge, an innovative center that has resources and people eager to work together to resolve alarm fatigue. Our success will not be just in what we’re able to do as a center, but also in what we can get vendors to do,” Mortara said in a prepared statement.

In February, Hill-Rom closed a $300 million acquisition of Mortara Instrument after having originally announced intention to acquire the biz in January.

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Novaliq’s NovaTears dry eye disease therapy launches in New Zealand

NovaliqNovaliq today launched its dry eye disease therapy, NovaTears, in New Zealand and said that it won registrational approval in Australia.

The Germany-based company inked an exclusive licensing partnership earlier this year with AFT Pharmaceuticals (ASX:AFP) to commercialize Novaliq’s water-free topical eye drops in Australia.

Get the full story at our sister site, Drug Delivery Business News.

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Arthrosurface acquires allograft tech from Wasas

ArthrosurfaceArthrosurface said today that it paid an unspecified amount to acquire an acellular dermal stabilization device technology from Wasas LLC.

Derived from human tissue, acellular dermis is made using a process that removes cells but retains portions of the extracellular matrix to create dermal allografts.

The deal includes the patent rights for the technology, which Franklin, Mass.-based Arthrosurface plans to develop and market “a platform of novel methods to be used to correct orthopedic challenges” for several indications. Wasas is based in Ft. Lauderdale.

“The availability of this allograft to Arthrosurface will allow us to execute on a pipeline of clinical applications that we have identified with our surgeon partners over the past several years,” CEO Steve Ek said in prepared remarks.

In March 2014 Arthrosurface won 510(k) clearance from the FDA for its ToeMotion Total Toe fixation system.

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J&J’s DePuy Synthes launches TFNA hip repair system

DePuy Synthes

Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes said today it launched the TFNA augmentation system designed to treat patients with hip fractures who have poor bone quality.

The company touted the system as the 1st and only polymethylmethacrylate cement with indications for specific traumas. The system is designed to be used to enhance implant fixation in cases where there is a significant potential risk of cut-out.

“The TFNA Augmentation System addresses an important clinical need for patients who undergo hip fracture surgery, especially those who suffer from poor bone quality. This new system complements the TFNA System and has the potential to improve patient outcomes, reduce costs, and increase patient satisfaction,” DePuy Synthes trauma franchise medical leader Dr. Charisse Sparks said in a prepared statement.

Earlier this month, DePuy Synthes said it launched the Maxframe multi-axial limb correction system designed to gradually correct bone or soft tissue deformities in the arm, leg, foot or ankle.

DePuy said the Maxframe system includes 3D planning software intended to create accurate patient treatment plans and reduce the number of X-rays required and the procedural complexity of treatments.

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Cordis inks exclusive distribution deal for Medinol’s coronary stent portfolio in US

Cordis, MedinolCordis has inked an exclusive distribution deal to sell Medinol‘s coronary stents in the U.S., the company reported, adding a cobalt-chromium bare-metal stent and a drug-eluting stent to its portfolio.

According to the deal, Cordis plans to start selling Medinol’s NIRxcell BMS immediately and will exclusively distribute the company’s EluNir drug-eluting stent if it wins FDA approval.

Get the full story at our sister site, Drug Delivery Business News.

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Report: Doctor self-diagnoses cancer while testing Butterfly iQ ultrasound

Butterfly iQ

A vascular surgeon was able to diagnose his own cancer while testing the Butterfly Network’s Butterfly iQ ultrasound-on-a-chip device, according to a report from USA Today.

After experiencing some throat discomfort Dr. John Martin self-tested the device, designed to send images to and operate in conjunction with Apple (NSDQ:AAPL) iPhones, and found a mass that he thought looked cancerous, according to the report.

The mass turned out to be squamous cell cancer which Martin has since received treatment for, including surgery and radiation therapy.

“I felt something funny in my neck, connected the probe to my phone, did an ultrasound, and there it was: My tumor,” Martin said, according to USA Today.

The Butterfly iQ device won FDA 510(k) clearance earlier this month with 13 clinical indications, which the Guilford, Conn.-based company touts as the “broadest every for a single ultrasound transducer.”

Butterfly said its device consists of a single wide-band, 2D matrix array with thousands of microelectromechanical systems overlaid on an integrated circuit.

The company touted that the cost of the device was significantly lower than existing technology, saying it could reduce costs between 10 to 100 times.

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InterRad Medical raises another $5m for SecuraCath

Interrad MedicalInterrad Medical last week reported raising another $5 million for its SecuraCath device, saying it hopes to raise $2 million more.

SecurAcath is designed with small insertable anchors at the point of catheter entry to keep catheters from moving or coming loose in patients. The attachment device eliminates the need to suture or adhesively attach catheters. The device won 510(k) clearance from the FDA in 2010.

The most recent debt funding, revealed in an Oct. 26 filing with the U.S. Securities & Exchange Commission, adds to the $10 million Series C round the Plymouth, Minn.-based company raised in 2011. Another $7.5 million raise followed in 2014.

In 2015 the company landed a Federal Supply Schedule contract with U.S. Veterans Affairs Dept. and Defense Dept. hospitals for SecurAcath.

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Physio-Control recalls Cardinal Health-made pediatric AED electrodes

Physio-Control, Cardinal Health

Physio-Control said today it launched a voluntary recall of pediatric defibrillation electrodes, made by Cardinal Health (NYSE:CAH), which are components in a number of the company’s Lifepak automated external defibrillators over issues with incorrect art that could lead to misuse.

Redmond, Wash.-based Physio-Control said that artwork on the recalled defibrillation electrodes shows incorrect electrode placement for an infant that could lead to ineffective energy delivery to the patient and serious injury or death.

The recall affects approximately 14,200 electrodes used with the company’s Lifepak Express AED, Lifepak CR Plus AED, Lifepak 1000 defibrillator and Lifepak 500 Biphasic AEDs with pink connectors. Adult defibrillation leads were not affected by the recall, according to a press release.

Physio-Control said it is reaching out to customers to inform them of the issue and is providing correct instructions to be used with the affected AEDs until corrected electrodes are distributed. The company said that if customers decide not to use the electrodes, they can “consider the use of adult defibrillation electrodes until they receive their replacement set of infant/child defibrillation electrodes.”

The company advised customers to report any malfunctions or adverse events to it and the FDA.

In April, Physio-Control won a $28.3 million contract with the US Dept. of Defense for “medical equipment, maintenance of medical equipment, and/or spare parts for medical equipment.”

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Allergan’s intravitreal implant wins approval in China

AllerganAllergan (NYSE:AGN) said today that it landed an imported drugs license from the Chinese FDA to market its dexamethasone intravitreal implant, Ozurdex, as a treatment for adults with macular edema following branch retinal vein occlusion or central retinal vein occlusion.

The Dublin-based pharma giant touted its therapy as the first intravitreal injection approved for RVO in China.

Get the full story at our sister site, Drug Delivery Business News.

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Riverfield Surgical Robot Laboratory raises $10m to challenge Intuitive Surgical in Japan

Riverfield's EmaroRobot-assisted surgery startup Riverfield Surgical Robot Laboratory reportedly raised more than $10 million (¥1.15 billion) for the Emaro robot-assisted surgery platform it’s developing.

Based on technology developed at the Tokyo Institute of Technology, Riverfield plans to have its device on the Japanese market by 2020, selling at half the price of the da Vinci robot marketed by industry behemoth Intuitive Surgical (NSDQ:ISRG), the Nikkei Asian Review reported.

Get the full story at our sister site, The Robot Report.

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Abbott wins CE Mark for next-gen Xience Sierra drug-eluting stent

Abbott logoAbbott (NYSE:ABT) said today that it won CE Mark approval in the European Union for its next-generation drug-eluting stent, the Xience Sierra.

The everolimus-eluting coronary stent is designed to allow cardiologists to treat the complex lesions that make up roughly 70% of cases, the Chicago-area healthcare giant said. If offers a thinner profile, increased flexibility, longer lengths and smaller diameters than previous stents.

Get the full story at our sister site, Drug Delivery Business News.

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HighLife Medical raises $14m for transcatheter mitral valve replacement

HighLife MedicalHighLife Medical said today that it raised more than $14 million for the replacement heart valve it’s developing to treat mitral regurgitation.

Paris- and Irvine, Calif.-based HighLife said the €12.3 million round was led by European venture capital shop Soffinova Partners, joined by prior backers LivaNova (NSDQ:LIVN) and HighLife founder & CEO Georg Börtlein – who also co-founded CoreValve, the aortic valve replacement company acquired in 2009 by Medtronic (NYSE:MDT) for $700 million.

HighLife’s transcatheter mitral valve replacement uses a ring around the diseased valve’s leaflets that’s designed to guide the replacement valve into position.  It’s designed to be delivered through the inter-atrial septum, rather than via a trans-apical approach involving a puncture in the heart muscle, the company said.

“This investment enables us to implement our aggressive development plan and move forward with both our ongoing clinical programs and our R&D pipeline. We are currently recruiting patients in several European countries including France and Germany and are now planning to accelerate the enrollment of this initial clinical phase,” Börtlein said in prepared remarks.

“We are excited to invest in HighLife and believe that their unique trans-septal approach is the next innovative disruption in transcatheter valve technologies,” added Soffinova managing partner Antoine Papiernik. “We are also happy to partner with Georg Börtlein for the second time and confident that HighLife’s technology represents the next-generation TMVR product needed to reach meaningful clinical adoption.”

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Anatomics’ custom 3D-printed sternum implant used in US 1st replacement procedure

Anatomics custom 3D printed sternum implant

Anatomics said this month that a custom 3D-printed implant it created was successfully implanted to replace the sternum and partial ribcage of a 20-year old patient who had lost significant bone mass to Chondrosarcoma, touting the procedure as a 1st for the US.

The implant was composed of composite titanium and porous polyethylene designed using high-resolution CT scans of the patient’s chest, approved by an operating surgeon. The implant was only the 2nd of its kind to use the company’s PoreStar technology, though Anatomics has been innovating in the field of 3D printing for over 2 decades.

Anatomics has been making 3D printed medical models for 25 years, CEO Dean Carson told MassDevice.com in an interview, though its technology has seen significant leaps in quality since then.

“The 3D imagery capability 25 years ago were nowhere near at the high quality they are today. In order to provide the final product of a patient-specific implant it’s necessary to have high resolution CT imagery. Now the technology has advanced to a point where we can be very confident that what we’re looking at is a good representation of the patient’s anatomy,” Carson said.

Carson thinks that the technological advances will have a significant impact on procedures and increase the use of bespoke implants, removing the need to rely on off-the-shelf implants which are currently the standard of care.

“The technology has the ability to alter the approach that a surgeon takes to treating a patient. I think that’s what’s so powerful about this technology – we’re seeing a shift in the medical field approach to treating patients. It’s really driven by the ability to have high quality patient-specific implants available for treating their patients,” Carson said.

The bespoke nature of the implant and advanced technology had a significant impact in terms of pain relief and improved quality of life, according to patient Penelope Heller, who also spoke to MassDevice.com about the procedure.

Heller underwent a procedure in 2014 to remove a malignant bone tumor after a diagnosis of Chondrosarcoma, a rare cancer affecting bones and joints that is resistant to chemotherapy and radiotherapy and requires surgical removal. But the surgery left Heller with a significant amount of pain and discomfort, she said.

“The reason I sought another surgery is that over the years I reached a level of discomfort and chronic pain that I found to be just unacceptable and I figured I’d look into options,” Heller said. “I contacted Anatomics, told them my story. I had contacted Anatomics in Australia and didn’t even know that they had offices in the States. At first I was told that Anatomics doesn’t have any FDA approval so it might be difficult.”

CEO Carson eventually heard Heller’s story and gained interest – and though the technology is not currently cleared by the FDA for general use, a procedure was able to be performed under the FDA’s Expedited Access, or compassionate use, pathway.

A procedure to revise the prior implant was performed on August 2 at the NewYork-Presbyterian/Weill Cornell Medical Center, led by Dr. Jeffrey Port. Heller said she was able to tell a significant difference within approximately 2 weeks.

“My first surgery was on September 15, and at Thanksgiving I was still taking painkillers – I was taking narcotic painkillers a couple times a day and Tylenol pretty much around the clock,” Heller said. “I had my [second] surgery on August 2, and I stopped all narcotic painkillers, I want to say, on August 15 or 16 … I stopped taking Tylenol in the week after that. That speaks for itself in terms of pain.”

Heller said that outside of reduced narcotic use, she was also taking steps to explore quantitative results after the procedure, having contacted labs at Columbia Presbyterian Hospitals OEP lab to explore pre and post-op results.

“I contacted the researcher there and I got that testing done before my surgery in addition to a pretty standard exercise stress test with some breathing measurements as well. Those results are very interesting and pretty different pre-op and post-op,” Heller said. “My favorite result of that test is that before this August 2 operation, I was moving 64% of the predicted air volume for my age and height and weight, and post-op I’m moving, I think 98% of that number – 98% of the predicted number. That, to me, seals the deal and makes me even more excited about the choice that I made to get the surgery, that one number was really exciting to me.”

Carson said that the company is also dedicated to collecting objective data as it looks to explore the quantitative benefits Heller received from the custom implant it produced, and it hoped those results would help support regulatory clearance.

“That objective data is very important for us and also for the regulators,” Carson said.

The company has a submission for FDA 510(k) approval pending with the agency, Carson said, and is continuing to collect data on its PoreStar platform.

“Anatomics is humbled by the strength of the thousands of patients we have helped over 25 years since inventing BioModeling technology. The patient’s story is one of many, but what makes it truly remarkable is how the patient and her family, Dr. Port and the staff at NewYork-Presbyterian/Weill Cornell, Anatomics, and the FDA came together to make this story a reality. It was a group effort that began with the patient’s pursuit of information,” Anatomics’ exec chair Paul D’Urso said in a press release.

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FDA releases med device company patient data sharing guidelines

FDA medical device recalls

The FDA this week released guidance clarifying its position on sharing patient-specific information gathered by medical devices, saying it supports the release of such information by device developers at a patient’s request.

The agency clarified that it sees “patient-specific information” as information “unique to an individual patient or unique to that’s patient’s treatment or diagnosis that has been recorded, stored, processed, retrieved, and/or derived from a legally marketed medical device.”

The FDA said that device companies that choose to release such information can “do so without undergoing additional premarket review in advance,” and that it would not consider patient-specific information to be “labeling.”

The agency said that for any information shared, it should be “comprehensive and contemporary.”

“For example, if a patient requests from a manufacturer a history of her own blood pressure measurements from a device, the data should include all available data up through the most recent measurement. Manufacturers may also format the patient-specific information to facilitate its usability by the patient,” the FDA wrote in its guidelines.

The federal watchdog added that while it supports manufacturer-shared information with patients if the patient requests such data, such companies would not be required to do so.

For data that is difficult to share with patients due to its format or for data that would require redesigned devices to convey such information, the FDA said that a company should not feel inclined to share it.

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Zebra Medical vision looks to offer AI-assisted imaging scans for $1

Zebra Medical Vision

Israeli machine-learning radiology firm Zebra Medical Vision said today it plans to launch its AI1 automated imaging analytics tools to healthcare providers for approximately $1 per scan.

The company said it has developed a deep learning engine platform that can detect various medical findings from image scans on its own, including the detection of liver, lung, cardiovascular and bone disease.

Zebra Medical Vision said it is also planning to introduce new capabilities that would cover breast cancer, lung cancer, brain trauma, hypertension and other clinical areas.

“With this new model, we hope to facilitate adoption globally, especially in countries where access to radiology is difficult. We are making a commitment to provide our current tools, and all future ones, for a flat $1 USD per scan. By doing so we believe that a true difference can be made in the provision of radiology services worldwide,” co-founder & CEO Elad Benjamin said in a press release.

The system is designed to integrate findings into PACS and RIS systems for easier reading and reporting, and is currently deployed at over 50 hospitals with over 1 million images analyzed to date, the company said.

Last May, Zebra Medical Vision raised $12 million to support its imaging analytics platform.

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Stealthy neuromod dev Syntilla Medical raises $2m

Syntilla Medical

Stealthy Syntilla Medical has raised $1.5 million in a round of debt financing, according to an SEC filing posted last month.

The company has not publicly disclosed its developments, but has filed for a number of patents related to implantable neurostimulation systems to treat head pain, according to patent listing site Justia.

The company has filed patents for a system designed to treat head pain through implantable devices, including a pulse generator and systems for recharging and communicating between devices, according to the Justia patent listings.

Syntilla did not respond to requests for more information on its developments or future plans.

Money raised in the round came from 21 unnamed investors with the first investment noted on March 21, with Syntilla still looking to raise an additional $4 million before closing the offering.

Proceeds from the offering are slated to fund general operations, with the possibility of using some funds for regular compensation of the CEO, according to the SEC filing.

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Trump’s opioid public health emergency highlights differences with FDA

Capitol HillPresident Donald Trump yesterday declared the opioid epidemic a national public health emergency – a move that he said will help “liberate our communities from this scourge of drug addiction.”

The president, surrounded by lawmakers and advocates, said that the government’s plan to fight the opioid epidemic would include “really tough, really big, really great advertising” that would try to persuade people against using drugs in the first place.

“This was an idea that I had, where if we can teach young people not to take drugs, it’s really, really easy not to take them,” Trump said.

His plan to combat the nation’s drug problem with the willpower of the average American is vastly different from the strategy highlighted by FDA commissioner Dr. Scott Gottlieb, who earlier this week underscored the importance of expanding access to medication-assisted treatment to curb the opioid epidemic.

Get the full story at our sister site, Drug Delivery Business News.

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Ambu pays $261m for Invendo Medical

Invendo MedicalAmbu (CPH:AMBU-B) this week said it agreed to put $261 million on the table for Invendo Medical and its line of disposable endoscopy devices.

Copenhagen-based Ambu said it paid $133.2 million (€115 million) up front for Invendo, with another $127.4 million (€110 million) in possible milestones. Those include a $81.1 million (€70 million) payment pegged to FDA clearances and $46.3 million (€40 million) in earnouts over four years. Some $11.6 million (€10 million) is expected to come due this fiscal year after Invendo wins 510(k) clearance from the FDA for the next iteration of its HD colonoscope.

Kissing, Germany-based Invendo, which employs 35 workers, was founded in 2002.

“This acquisition is a massive upgrade of our business potential. We introduced single-use endoscopy for airway procedures with the Ambu aScope, and now, we will get ready to introduce single-use for the gastrointestinal procedures,” CEO Lars Marcher said in prepared remarks. “This is an important acquisition that puts Ambu in an ideal position to further disrupt the reusable market within endoscopy.”

Copenhagen-based Ambu last year paid $16 million to acquire ETView Medical (TLV:TLV) and its portfolio of airway management devices.

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Align Technology shares soar on solid Q3 beat

Align Technology

Shares in Align Technology (NSDQ:ALGN) have risen over 15% today after the orthodontic device maker beat expectations on Wall Street with its third quarter results.

The San Jose, Calif.-based company posted profits of $82.6 million, or $1.01 per share, on sales of $385.3 million for the 3 months ended September 30, for bottom-line growth of 60.7% while sales grew 38.3% compared with the same period last year.

Earnings per share were well ahead of the 82¢ consensus on Wall Street where analysts were expecting to see sales of $359.8 million for the quarter.

“I’m pleased to report another strong quarter and results that exceeded our expectations across our key financial metrics including revenue, volume, margins, and EPS. Third quarter revenues increased 38.3% year-over-year driven by increased Invisalign volumes across all our geographies, as well as strong growth from iTero scanners. Our strong third quarter results also reflect accelerated growth from teenager patients in both North America and the Asia Pacific region, with total Invisalign shipments up 46.3% year-over-year and up 26.5% from the second quarter. On a sequential basis, revenues increased 8.1% driven by continued strength across Asia Pacific, which offset expected seasonality in Europe, as well as higher than expected revenues from shipments to SmileDirectClub,” prez & CEO Joe Hogan said in a press release.

Align released updated guidance for the fourth quarter of 2017, expecting to see revenues between $391 and $398 million and diluted EPS of between 92¢ and 95¢.

Shares are trading up 16.3% so far today, at $236.05 as of 12:39 p.m. EDT.

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FDA clears Butterfly Network’s iQ ‘ultrasound-on-a-chip’

Butterfly iQ

Medical device developer Butterfly Network said today it won FDA 510(k) clearance for the Butterfly iQ Apple (NSDQ:AAPL) iPhone-connected Ultrasound system, which claims is the world’s first ultrasound-on-a-chip system.

The device is now indicated for 13 clinical applications, which the Guilford, Conn.-based company touts as the “broadest every for a single ultrasound transducer.”

“Offering a unique blend of affordability, diagnostic versatility, and assistive intelligence, Butterfly has the potential to impact human health more profoundly than any diagnostic device since the stethoscope, invented over 200 years ago. At less than $2,000, healthcare providers can purchase an easy-to-use, powerful, whole-body medical imaging system that fits in their pocket. By removing the barrier of price, I expect Butterfly to ultimately replace the stethoscope in the daily practice of medicine. We can now provide a diagnostic system to address the millions of children that die of pneumonia each year and the hundreds of thousands of women that die in childbirth, and these are just two examples of the impact this technology will have,” chief medical officer Dr. John Martin said in a press release.

Butterfly said its device consists of a single wide-band, 2D matrix array with thousands of microelectromechanical systems overlaid on an integrated circuit.

The company touted that the cost of the device was significantly lower than existing technology, saying it could reduce costs between 10 to 100 times.

“Just as putting a camera on a semiconductor chip made photography accessible to anyone with a smart phone and putting a computer on a chip enabled the revolution in personal computing before that, Butterfly’s Ultrasound-on-a-Chip technology enables a low-cost window into the human body, making high-quality diagnostic imaging accessible to anyone. Two thirds of the world’s population has no access to medical imaging, that’s not ok, and today our team is doing something about it. And they are just getting started,” founder & chair Dr. Jonathan Rothberg said in a prepared release.

Butterfly said it plans to release assistance and interpretation functionality using deep learning-based artificial intelligence some time in 2018.

“Deep learning and ultrasound imaging are a perfect combination. As physicians use our devices in the field, they help improve the neural network models. The more physicians use Butterfly devices, the better they will get. Improvements to acquiring and interpreting images will ultimately enable less skilled users to reliably extract life-saving insight from ultrasound,” prez Gioel Molinari said in prepared remarks.

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