RenovaCare chairman ponies up nearly $16m for wound-healing stem cell SkinGun

RenovaCare (Scottsdale, Ariz.) has announced an equity financing for $15.5 million from Kalen Capital Corporation, the family office of Harmel Rayat, who is the majority shareholder and chairman of RenovaCare. The equity financing increases his family office’s total equity investment in RenovaCare to over $20 million.

“Our long-term investment in RenovaCare speaks to our conviction that patients worldwide urgently need and deserve our regenerative SkinGun therapy, which sprays a patient’s own stem cells for rapid self-healing,” Rayat said in a press release. “I’m more confident than ever in our mission to replace painful and costly skin grafting surgeries with an ultra-gentle healing mist of one’s own skin cells. I believe we are in the right place, at the right time and with the right technology.”

The investment round allows the company to move forward in the regulatory approval process and clinical trial program. Rayat’s previous investment rounds allowed for pre-clinical development, product engineering and intellectual property filings.

Get the full story on our sister site, Medical Design & Outsourcing.

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Philips recalls lithium-ion defibrillator batteries

Philips HeartStart products

Philips Healthcare has issued a worldwide recall of batteries for its HeartStart MRx monitor/defibrillator.

The Philips M3538A lithium-ion batteries manufactured from December 28, 2017 to March 20, 2018 for the HeartStart MRx monitor/defibrillator may have an internal component failure and may fail to charge or to provide power, according to a statement by the U.K. Medicines and Healthcare products Regulatory Agency. The FDA had not released a statement of its own.

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J&J’s Biosense Webster launches Heliostar multi-electrode ablation cath trial

Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said this week that it enrolled and treated the first patient in its Stellar U.S. investigational device exemption study.

The 640-patient trial is designed to assess the safety and efficacy of the Heliostar multi-electrode radiofrequency balloon ablation catheter as a treatment for drug refractory recurrent paroxysmal atrial fibrillation.

The Heliostar device features 10 electrodes and is designed to allow electrophysiologists to achieve pulmonary vein isolation with a single application of RF energy, according to Biosense Webster.

Cardiac electrophysiologists Drs. Rodney Horton and Andrea Natale treated the first patient in the Stellar study at the Texas Cardiac Arrhythmia Institute.

“This new balloon catheter is unique because it conforms to any pulmonary vein anatomy and allows me to control electrodes individually to deliver tailored energy when ablating around pulmonary veins,” Dr. Horton said in prepared remarks.

“The Heliostar catheter design has the potential to overcome the limitations of current balloon ablation catheters, result in fewer catheter exchanges and, most importantly, shorter procedure times. Heliostar is an exciting technology and we look forward to seeing the final study results,” Dr. Natale added.

“The Stellar study is an important step forward in expanding treatment options for atrial fibrillation patients in the United States,” Uri Yaron, worldwide president of Biosense Webster, said. “The burden of atrial fibrillation on quality of life, morbidity and mortality is significant and we are committed to developing innovative and life-enhancing technologies that fill important clinical needs, improve care and reduce this burden.”

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Diabeloop wins CE Mark for hybrid closed-loop diabetes management system

Diabeloop won CE Mark clearance in the European Union this month for its hybrid closed-loop diabetes management system, DBLG1.

The Paris-based company hopes to launch its “artificial pancreas” system for adults with Type I diabetes in Europe by the second quarter in 2019.

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

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Boston Scientific sues Micro-Tech over endo clip patents

Micro-Tech SureClip

Boston Scientific has filed a lawsuit against Micro-Tech USA and its Chinese manufacturer, Micro-Tech Nanjing, alleging that Micro-Tech infringed three of its patents for endoscopic hemostatic clips.

Boston Scientific claims that Micro-Tech’s SureClip hemostasis clip products infringe the patents for its Resolution and Resolution 360 clips, which are designed to control gastrointestinal bleeding. Henry Schein (Melville, N.Y.) is also named as a defendant as Micro-Tech’s distributor.

Boston Scientific claims that Ann-Arbor, Mich.-based Micro-Tech’s SureClip, SureClip Mini, and SureClip Plus hemostasis clips infringe patents on its Resolution clips, which apply clips to tissue or to a blood vessel to stop bleeding. Boston said it obtained the patents in 2006, 2015 and 2018.

Micro-Tech’s SureClip products contain several of the elements of Resolution clips, according to the lawsuit, filed in U.S. District Court in Delaware. Regarding clips that attach to tissue (its ‘725 patent), Boston Scientific alleges that Micro-Tech’s clips include a flexible sheath that can pass through the bends of an endoscope and reach the target tissue; a capsule that extends from the proximal to the distal ends with clips on both ends and clip arms; and a pair of J hooks that are “releasably connected to the clip assembly.”

In the claim about its ‘245 patent, Boston Scientific alleges that SureClip products designed to stop bleeding of a blood vessel contain the following similar elements to its Resolution products: a clip having at least two clip legs; a breakable link adapted to couple a control wire to the clip and broken by force applied by the control wire; a control wire that can open and close the clip legs; an axially rigid sheath enclosing the control wire; a handle; and an actuator for the control wire.

Boston Scientific also describes SureClip products as containing elements that infringe its ‘371 patent, including a capsule, clip assemblies with two clip arms that can clip tissue, a control element, and a sheath that covers at least a portion of the control element, and which is releasably coupled to the capsule.

MicroTech and Henry Schein did not immediately offer comment on the lawsuit.

 

 

 

 

 

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Merit Medical wins FDA nod for EmboCube embolization gelatin

Merit Medical received FDA 510(k) clearance for its EmboCube embolization gelatin.

EmboCube is used in the embolization of hypervascular tumors. It features uniformly cut cubes of gelatin foam that have been designed to address preparation concerns and inconsistent particle sizes that come with traditional gelatin foam sheets as an embolic. Embocube gets preloaded into a Medallion syringe to deliver the gelatin smoothly and with minimal to no resistance.

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Pulmatrix raises $3m in offering

Pulmatrix (NSDQ:PULM) said this week that it inked a deal with an institutional investor to sell 9,375,000 shares of common stock at
32¢ apiece.

The Lexington, Mass.-based company expects to reel in $3 million in total gross proceeds from the offering.

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

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ParaGen Technologies closes $3m bridge funding round

ParaGen Technologies recently closed a $3 million bridge funding round. Ikove Venture Partners managed and organized the round through its network of investors. About 70% of the funds came from 10 different countries.

ParaGen has developed a platform scaffold technology that uses tissue engineering to address biologic and synthetic implants. Its four portfolio companies include RenovoDerm, Atreon Orthopedics, Vascular Genesis and Tarian Medical. Each company is making products for wound care, orthopedic, peripheral vascular and hernia markets.

Get the full story on our sister site Medical Design & Outsourcing.

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Monteris Medical scores reimbursement win with Aetna

More epilepsy patients could have access to procedures involving Monteris Medical’s NeuroBlate system after a new coverage update from health insurance giant Aetna.

The coverage update, which Monteris Medical announced today, involves Aetna’s medical policy for laser interstitial thermotherapy (LITT). It provides coverage for Aetna beneficiaries with refractory epilepsy who have met the established medical necessity criteria for a surgical treatment option.

“Our aim is to ensure that physicians can choose the most appropriate surgical approach for their patients. For many epilepsy patients, a minimally-invasive alternative will be the right choice,” Monteris Medical Martin J. Emerson said in a news release.

“By reducing the barriers for epilepsy patients seeking minimally-invasive intervention options, Aetna has empowered more individuals and their families to pursue options that will best meet their needs,” Emerson said.

The NeuroBlate surgical system is minimally invasive and robotic. It uses lasers to ablate brain lesions.

The coverage update from Aetna represents more good news for Monteris Medical after a rocky start to 2018, when FDA labeled a Monteris recall as Class I. The recall involving unexpected heating and damage to the tip of the probe when it interacted with an MRI.

Monteris Medical resolved the heating issue last month when it received FDA clearance for a laser probe with fiber optic controlled cooling to use in the NeuroBlate system. The probe replaced metal thermocouple inside the laser probe, and enabled Monteris to lift MR scan restrictions.

Also last month, Monteris announced that more than 2,000 patients have been treated with the NeuroBlate system since its market release in 2013.

Monteris Medical in June announced the completion of a $26.6 million Series C financing.

 

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Ex-Zimmer Biomet SVP loses in court

A former Zimmer Biomet executive has temporarily lost her bid for severance pay and cannot claim company stock options after her 2016 resignation.

Robin Barney resigned from her post as a senior vice president claiming a hostile work environment, alleging sex discrimination, breach of contract, and constructive or involuntary discharge.

Barney became Zimmer’s SVP of global operations and logistics after serving as an SVP at Biomet since 2008. (The companies merged in 2015.) Barney alleged that Zimmer told her in August 2016 that her position would be moved from Indiana to Switzerland by the end of 2017, requiring her to relocate. Barney refused.

She also alleged that in October 2016, “Zimmer’s CFO demanded that she concoct a story to mislead Zimmer’s investors about the cause of recent quarterly shortfalls,” court documents said. Barney refused again. She also claimed that the company pressured her about sales and product shipments related to one of its facilities, even though production had already been shut down at that facility due to an FDA audit.

Barney claimed that Zimmer CEO David Dvorak ordered her to terminate employees under a false pretext in October 2016. Again she refused and claimed she was told that Dvorak “was not happy with her refusal, and that they would talk further about it.”

Barney submitted her resignation that same day, later claiming that she had no choice because these incidents constituted intolerable conditions, and “she further wished to extricate herself from the potential securities fraud being committed by other executives,” court documents said.

U.S. District Court Judge Jon DiGuilio dismissed Barney’s claim for severance pay because Barney did not specifically claim in her lawsuit that she told Zimmer within 30 days that she would not relocate to Switzerland. DiGuilio allowed her the ability to make this claim again.

The court also found that she didn’t qualify for vesting of stock options because she hadn’t worked for Zimmer for 10 years. Ruling from U.S. District Court for Northern Indiana, South Bend Division, DiGuilio also said that Barney had “not made sufficient allegations that anyone at Zimmer led her to reasonably believe that she would be terminated for refusing to mislead investors (or for refusing to terminate employees, for that matter)….

“In sum, Barney has failed to adequately allege that Zimmer breached its Employment Agreement with her, or that Zimmer subjected her to a wrongful constructive discharge,” the judge concluded.

 

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FDA issues revised draft guidances for blood glucose monitors

The FDA issued two revised draft guidances today relating to over-the-counter and prescription blood glucose monitors.

The new documents, which are intended to update guidances issued in 2016, were based on feedback from stakeholders, who requested more clarification on design considerations and recommended standards, according to the U.S. regulatory agency.

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

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Reshape Lifesciences settles with institutional investors for $700K

Just days after it announced that it had raised $10 million in a registered direct offering, ReShape Lifesciences (NSDQ:RSLS) disclosed in a regulatory filing that it’s paying $350,000 to each of the two institutional investors involved.

The U.S. Securities and Exchange Commission filing, dated yesterday, said the money settles a dispute that arose prior to the closing of the registered direct offering.

The two investors agreed to buy 8 million shares of ReShape common stock as well as warrants to purchase 8 million shares, at a purchase price of $1.25 per share, according to a previous news release. H.C. Wainwright & Co. acted as the exclusive placement agent.

On top of the $10 million raised in the registered direct offering, the weight loss device maker has also brought in $15 million related to an at-the-market facility that commenced in October.

“We are really pleased with the progress we have made in getting our capital structure back to health,” ReShape CEO Dan Gladney said in a news release yesterday.

“We believe that the completion of these recent financings combined with the previous series of financings, the elimination of the series D convertible preferred shares and the reduction of our monthly burn rate from $3.5 million to $1.5 million, position ReShape Lifesciences with a solid runway to execute our strategic plan,” Gladney said.

This isn’t the first time this year that ReShape has run into troubles with a money raise. In August, the company disclosed that it withdrew from an underwriting agreement with H.C. Wainwright & Co. because Nasdaq determined that the offering was not a public offering and therefore could not be completed without shareholder approval.

The company’s stock has been trading under $1 per share in recent days.

ReShape (San Clemente, Calif.) has been developing minimally invasive medical devices to treat obesity and metabolic diseases. Its portfolio includes the ReShape Balloon, ReShape vBloc, and ReShape Vest.

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Abbott faces suit from FlexStent over stent patent

FlexStent alleged in a lawsuit this week that Abbott infringes a vascular stent patent with its Xience line of drug-eluting devices.

The suit, filed Nov. 26 in the U.S. District Court for Central California, accused Abbott’s Xience stents of infringing on U.S. Patent 6,187,035. The Xience devices infringe Claim 1 of the ‘035 patent, which specifies a stent with specific width and thickness ranges for its vertical and horizontal branches.

The FlexStent patent calls for vertical branches with thicknesses between 0.09mm and 0.12mm, horizontal branch thickness of 0.05mm to 0.09mm and branch thickness ranging from 0.08mm to 0.12mm. The Xience device cited in the lawsuit has vertical branches of 0.09906mm to 0.1016mm, horizontal branch width of 0.0762mm and thickness 0.08128mm – all within the range specified in the FlexStent patent, according to the lawsuit.

Abbott knew of the infringement because the patent’s prior owner told it in May 2015, the suit alleged.

“The prior owner also provided additional materials to defendants’ representatives demonstrating infringement of the patent, and corresponded and met with defendants’ representatives regarding defendants’ infringement of the patents. As a result, defendants knew and understood that offering to sell, selling, and using their accused products, including according to their encouragement and instructions, would infringe the ’035 patent,” the lawsuit alleged.

The suit seeks compensatory damages, costs, expenses, and pre- and post-judgment interest, enhanced damages for willful infringement and attorney’s fees and costs.

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Zeus: Try our heat shrink products at no cost

Polymer extrusion and tubing company Zeus seems to be taking a page out of the sales playbook of software companies and direct marketers.

Zeus (Orangeburg, S.C.) is telling medical device companies interested in switching to its peelable heat shrink tubing that they can initially try it out for free.

Get the full story on our sister site Medical Design & Outsourcing. 

 

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FDA clears Innovative Health to reprocess major manufacturers’ catheters

Innovative Health said it has nabbed FDA clearances to reprocess diagnostic catheters made by St. Jude Medical, Medtronic and Biosense Webster.

The catheters include St. Jude Medical’s Advisor FL, Medtronic’s Torqr and Marinr and Biosense Webster’s Decanav. Innovative Health said it is the first in the industry to receive clearances to reprocess the Advisor and the Decanav, and the only reprocessor to offer services to cardiac mapping and diagnostic ultrasound catheters from all major electrophysiology device manufacturers.

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Wishbone Medical picks up pediatric device maker Response Ortho

WishBone Medical said this week that it acquired Turkish pediatric fixation device maker Response Ortho for an undisclosed amount.

Istanbul-based Response’s portfolio includes 30 pediatric orthopedic systems; WishBone had eight before the acquisition, the Warsaw, Ind.-based company said.

Eighteen of the Response Ortho products are cleared or approved for the U.S. market. Wishbone said it’s opursuing 501(k) clearance for the others.

“With the acquisition of Response Ortho, we are thrilled about our pediatric orthopedic product offerings. The combination of Response Ortho’s thirty product systems and WishBone’s eight product systems will give WishBone Medical the broadest product portfolio in pediatric orthopedics worldwide,” founder, chairman & CEO Nick Deeter, who also founded OrthoPediatrics, said in prepared remarks. “These pediatric orthopedic products can be delivered in sterile packed, procedural kits anywhere in the world, next day, to the surgeons that care for children.”

“We are excited that Response Ortho is now part of WishBone Medical. Our primary focus has been outside the U.S., and we will now be able to offer these innovative orthopedic product systems everywhere. Having more than 50 years of combined experience, Nick and I understand the unmet needs and will provide global solutions to children with orthopedic issues,” added Response Ortho CEO Sehmuz Isin.

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Neural Analytics adds $10m for robot-assisted brain ultrasound

Neural Analytics yesterday reported raising nearly $10 million in for the robot-assisted brain ultrasound device it’s developing.

Los Angeles-based Neural Analytics’ NeuralBot is designed to work with its Lucid M1 transcranial doppler utrasound to provide non-invasive blood flow monitoring. In June the company won CE Mark approval in the European Union for NeuralBot.

In a funding round begun in May, Neural Analytics said it raised $9.5 million from 18 unnamed investors in an offering of debt, options, warrants and other securities, according to a Nov. 28 regulatory filing.

In January the company raised $15 million in a Series B round led by Alpha Edison.

“We are committed to advancing brain healthcare through transformative technology that empowers neurologists with the critical information needed to make clinical decisions and improve patient outcomes,” co-founder & CEO Leo Petrossian said in June. “Our products provide clinicians with a cost effective and non-invasive assessment of a patient’s brain health, and can help clinicians diagnose brain disorders, potentially without the need for more invasive testing.”

“This technology allows us to look inside the brain, evaluate blood flow characteristics and track emboli in patients. It provides us with critical information on brain health in real-time to help us diagnose neurological disorders, prior to the need for additional, more invasive testing,” added Dr. Claudio Baracchini of Italy’s University of Padua.

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Eyenovia touts publication of intraocular pressure data for micro-dose tech

Eyenovia (NSDQ:EYEN) said this week that the results of its Phase II PG21 study were published in the Nov. issue of the journal Clinical Ophthalmology.

The New York-based company’s Phase II study evaluated the effect of self-administered micro-dose latanoprost on intraocular pressure.

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

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Millar ends CD Leycom distribution agreement

Millar said today that it is discontinuing its exclusive North American distribution agreement with CD Leycom, maker of the clinical Inca pressure-volume (PV) loop system.

Officials at Houston-based Millar – a pressure sensors and medical device contract manufacturing company – plan to focus more on the company’s OEM division, which integrates pressure sensors based on microelectromechanical systems (MEMS) into medical devices.

Get the full story on our sister site Medical Design & Outsourcing.

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FDA delays some UDI compliance dates

Under pressure from manufacturers, the FDA is pushing back Unique Device Identification (UDI) compliance deadlines for some non-sterile, class I, and unclassified devices.

Devicemakers will have until September 24, 2020 before they must comply with standard date formatting, labeling and Global Unique Device Identification Database (GUDID) data submission requirements for these devices, according to the new guidance, published in the Federal Register Nov. 5. Manufacturers will also have until Sept. 24, 2022 before they must comply with direct-mark requirements for these devices.

Get the full story on our sister site, Medical Design & Outsourcing.

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Varian receives China NMPA approval for cancer treatment system

[Image from Varian Medical Systems]

Varian has received approval from China’s National Medical Product Administration for its Halcyon system to treat cancer.

The Halcyon system is designed to treat cancer patients with radiotherapy to treat lung, prostate, breast, head & neck and other forms of cancer. The system has a human-centered and user-friendly design to improve clinical workflow, accelerate installation timeframes, expedite commissioning, simplify training and automate treatment.

Get the full story on our sister site Medical Design & Outsourcing.

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Teva launches generic EpiPen at the same price as existing device

Teva (NYSE:TEVA) this week launched its generic version of Mylan‘s (NSDQ:MYL) EpiPen auto-injector and announced that it would sell the emergency allergy therapy for $300 – the same price as Mylan’s own generic EpiPen product.

The price for Teva’s product inspired some head-scratching among patient advocates and healthcare professionals. After all, when the FDA first approved Teva’s generic EpiPen, the agency highlighted the notion that boosting competition with generics would ultimately make the product more accessible to a general population. But, at the same price as Mylan’s discounted EpiPen, some are wondering how Teva’s product will reach patients who couldn’t afford Mylan’s device.

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

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CVS closes $70B Aetna buy

CVS Health (NYSE:CVS) said yesterday that it closed the $70 billion buyout of health insurer Aetna (NYSE:AET).

When the deal was announced in December 2017, the chief executives of CVS and Aetna said that they plan to transform CVS’s pharmacies and clinics into community-based healthcare sites, where people can access care at a more reasonable price than for a visit to the doctor’s office.

“Today marks the start of a new day in health care and a transformative moment for our company and our industry,” CVS Health president & CEO Larry Merlo said in prepared remarks. “By delivering the combined capabilities of our two leading organizations, we will transform the consumer health experience and build healthier communities through a new innovative health care model that is local, easier to use, less expensive and puts consumers at the center of their care.

“By fully integrating Aetna’s medical information and analytics with CVS Health’s pharmacy data, we can develop new ways to engage consumers in their total health and wellness through personal contacts and deeper collaboration with their primary care physicians,” Merlo said. “As a result, we expect patients will benefit from earlier interventions and better-connected care, leading to improved health outcomes and lower medical costs.”

The 10,000 CVS locations across the country provide a strategic advantage in that they’re already available and established within communities, Aetna CEO Mark Bertolini told The New York Times late last year.

“CVS has the draw,” Bertolini said. “People trust their pharmacist.”

“We think of it as creating a new front door to healthcare in American,” Merlo added.

The deal calls for Aetna stockholders to receive $145 in cash and 0.8378 CVS shares for each AET share, for a total value of $212 per share or roughly $70 billion, CVS said. The Woonsocket, R.I.-based company said it financed the deal with cash on hand and debt, including a $40 billion senior notes offering and a two-tranche term loan of $5 billion.

In order to close the deal Aetna had to deal its 2.2-million-member Medicare Part D drug plan to WellCare Health Plans (NYSE:WCG) per the terms of an agreement with the U.S. Justice Dept., CVS said. That deal is slated to close within the next few business days, the company said.

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Cantel Medical’s fiscal Q1 earnings meet The Street, but sales miss

Fiscal first-quarter earnings for Cantel Medical (NYSE:CMD) equaled the consensus forecast on Wall Street, but the medical device company miss the mark with its top-line number.

Little Falls, N.J.-based Cantel posted profits of $19.2 million, or 46¢ per share, on sales of $225.6 million for the three months ended Oct. 31, for a bottom-line slide of -16.1% on sales growth of 6.0% compared with fiscal Q1 2018.

Adjusted to exclude one-time items, earnings per share were 62¢ per share, dead even with The Street, where analysts were looking for revenues of $228.2 million.

“We are pleased to report good sales and non-GAAP earnings performance this quarter, and a return to strong growth in our medical segment. Our 6.0% reported sales increase was driven by organic growth of 4.3%, the impact from acquisitions of 2.3%, and an unfavorable impact from foreign currency of 0.6%. We continue to perform well internationally where sales were up 9.3% overall, and our US business had a solid quarter with 5.0% growth,” president & CEO Jørgen Hansen said in prepared remarks. “Our medical division had a great quarter, with double-digit growth in all regions and U.S. capital sales that returned to solid growth compared to the prior year. Our life sciences and dental businesses started the year softer than anticipated mostly due to the timing of orders, however we expect both segments to accelerate throughout the remainder of the year.”

Hansen said Cantel stood by its prior forecast for adjusted EPS of $2.57 to $2.62 on sales growth of 6.5% to 7.5% for the full fiscal year. The company has said it aims to reach the $1.3 billion sales mark in fiscal 2021, when it hopes to pull down $150 million in adjusted net income.

CMD shares closed up 2.3% at $90.43 apiece yesterday.

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This total body scanner shows 3D images of the whole body

A University of California Davis-developed medical imaging scanner has produced the first 3D picture of the whole human body at once.

The scanner, known as the Explorer, is a combination of a positron emission tomography (PET) and X-ray computed tomography (CT). It is able to image the entire body using both scanning methods and can produce the image in as little as one second. Over time, Explorer can make videos that can track specially tagged drugs as they move through the body.

UC Davis scientists Simon Cherry and Ramsey Badawi developed the scanner and suggest that the technology could be used in a number of applications that include improving diagnostics, tracking disease progression and researching new drug therapies. Explorer was developed in a partnership with Shanghai-based United Imaging Healthcare and will manufacture the devices for a broader healthcare market.

Get the full story on our sister site Medical Design & Outsourcing.

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Malaysian regulators launch new medical device databases

By Stewart Eisenhart, Emergo Group

The Malaysian Medical Device Authority (MDA) has rolled out two new databases for medical device registration information.

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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ElectroCore wins cluster headache FDA 510(k) indication for GammaCore

ElectroCore said today that it won expanded FDA 510(k) clearance for its GammaCore non-invasive vagus nerve stimulation therapy, now cleared for adjunctive use for the preventive treatment of cluster headaches in adult patients.

The Basking Ridge, N.J.-based company’s GammaCore device is a non-invasive, hand-held vagus nerve stimulation device designed for the reduction of pain. The system is intended to be applied to the neck and applies a patented electrical stimulation through the skin to activate the vagus nerve.

The expanded approval was supported by results from two studies which demonstrated the safety and efficacy of the system in preventing the treatment of cluster headaches, ElectroCore said, including data from its pivotal Preva study and a real-world retrospective study.

Results from the Preva study indicated that patients who received the standard of care and treatment and treatment with the GammaCore had a greater reduction in the number of cluster attacks per week from baseline than those who only received the standard of care. Patients treated with the GammaCore device experienced a total of 3.9 fewer attacks per week, ElectroCore said.

Data also indicated that 40% of patients who received GammaCore treatment alongside the standard of care had a 50% or greater reduction in weekly cluster attacks, versus only 8.3% of patients who received the standard of care, ElectroCore said. Investigators also noted a 57% decrease in the frequency of abortive medication for GammaCore patients.

The incidence of adverse events was noted as similar between both treatment and control cohorts, with most reported adverse events noted as mild or transient. The most common adverse events reported in the GammaCore group were headache, dizziness and neck pain at 8%, 8% and 6%, respectively. No serious adverse events were considered device-related, the company said.

“The FDA clearance of gammaCore for adjunctive use for the preventive treatment of cluster headache has the potential to help the approximately 350,000 Americans impacted by this debilitating condition often referred to as a ‘suicide headache. We are pleased that cluster headache patients now have a FDA-cleared option, and one that is both safe and effective, especially given the difficulty in treating cluster headache and the limitations of current treatments,” CEO Frank Amato said in a press release.

In August, ElectroCore said that it inked a collaborative research deal with Massachusetts General Hospital exploring the use of ElectroCore’s non-invasive vagus nerve stimulation tech in targeted treatments for neuroinflammation.

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Nexstim pulls trigger on 30-to-1 reverse split

Nexstim said this week it pulled the trigger on a 30-to-1 reverse split of its stock as the company looks to reduce its share capital.

Through the move, each shareholder in the Helsinki, Finland-based company will receive a single share for every 30 shares they previously owned.

The shift went into effect on Monday, with the company’s share numbers reduced to approximately 3.2 million. The reduction in shares was approved by the company’s board of directors earlier this month, the company said in a press release.

In May, NexStim said that it launched its Navigated Brain Therapy transcranial magnetic stimulation system designed to treat major depressive disorder in the US, having won FDA approval for the device last November.

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Report: Folded Ranier Tech’s spinal implants cleared in EU after tiny trial, found to dissolve in patients

Plastic spinal implants from now-defunct Ranier Technology are allegedly moving and dissolving in patients, calling into question the validity of the short, low-powered trial that won the device’s approval, according to a Guardian report.

The device in question, known as the Cadisc-L, won CE Mark approval in the European Union based on results from a six-month, 30-patient study, according to the report. The device underwent investigation by researchers from October 2009 until June 2010, winning approval in August.

Now, the devices are at the center of legal action from a number of patients who have undergone explant procedures to remove the disks, some of which have “completely disintegrated,” according to The Guardian.

Nearly 50% of patients implanted with the Cadisc-L have had to undergo follow-up surgeries, and scientific evidence seems to indicate that similar issues were noted during development, according to the report.

The discs were also implanted into nine baboons in an earlier animal trial, according to The Guardian. Data from a 2009 review of animals in the trial indicated that “overall six months is a relatively short time to follow and implant up,” and that there were “worrying changes between the implant and the bone in all but one subject.”

Details from the human trial were not published, according to the report.

Asked to respond to the accusations, former Ranier Tech CEO Dr. Geoffrey Andrews told The Guardian that the devices used in the baboons were custom-made and dissimilar to the devices that eventually made it to the market.

Andrews defended the devices, stating that “Ranier spent over eight years and more than £20 million in the design, development and testing of Cadisc-L,” according to the report.

He went on to state that the company’s decision to pull the devices from the market in March 2014 was based on the conditions of four patients who had to undergo follow-up surgeries related to the implants, according to The Guardian.

The paper’s data comes from the recently released ICIJ’s “Implant Files,” released earlier this week. The report raised a number of questions about the quality of the regulatory bodies that approve medical devices.

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Report: FDA-reported breast implant injuries kept hidden by summary reporting

The number of medical device reports sent to the FDA concerning issues with breast implants was kept artificially low through the use of summary reporting, according to a new report from the Honolulu Star Advertiser.

Between 2008 and 2015, the FDA received an average of approximately 200 medical device reports related to breast implants, significantly lower than the thousands the agency had come to expect prior to those dates, according to the report.

The lowered number of reports was due to a change at the FDA which allowed manufacturers of such devices to report issues in bulk, meaning a single filed report with the FDA could represent thousands of individual cases, according to the Star Advertiser.

Last year, however, the FDA instructed manufacturers to go back and file a single individual report for each case of patient injury after a lawyer’s discovery reported that his clients weren’t represented in the FDA’s databases, according to the report.

In the last half of 2017, the FDA received more than 4,000 injury reports related to breast implants. Another 8,000 reports followed during the first six months of this year, the Star Advertiser reports.

“It looked like these devices had become safer, but they hadn’t. The data was hidden. It’s a deceptive practice,” patient safety advocate Jamee Cook, who had textured saline breast implants removed after experiencing a number of health issues, told the Associated Press.

Public health advocates involved in the debate claim that summary reporting can be used to hide such data from patients and make devices seem safer, according to the report.

In August this year, the FDA made an adjustment that will allow 90% of all medical devices, including breast implants, to report malfunctions that don’t involve deaths or serious injuries in a quarterly tally instead of individual reports, the Star Advertiser reports.

The agency itself has dismissed claims that grouped reporting could create further issues or reduce transparency, saying that it believes the benefits will outweigh the negatives.

Earlier this month, the FDA laid out plans for improving post-market medical device oversight, including a significant investment in its new National Evaluation System for health Technology.

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5 keys to choosing a medical device CRO

John Lehmann, Director of Business Development, IMARC Research

When it comes to ensuring compliance, keeping your trial on track and bringing your medical device to market faster, having independent oversight from a strategic partner makes all the difference.

Because device trials bring unique compliance challenges, working with a contract research organization with specific expertise in medical devices will help your team be proactive in addressing them.

How can you be sure you hire a medical device CRO that is committed to ensuring compliance as you are?  Please review this slideshare that covers the five factors you need to look for when choosing a CRO that is the right fit.

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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Solaire Medical buys InnerSpace medical storage products lines

Solaire Medical (Marne, Mich.) said today that it has acquired the InnerSpace medical storage products lines from Stanley Black & Decker.

Financial terms of the deal, effective Sept. 28, 2018, were not disclosed. The purchase has resulted in redesigned products lines branded as InnerSpace by Solaire Medical. It also triples Solaire Medical’s number of employees to 75.

Get the full story on our sister site Medical Design & Outsourcing. 

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Amsel Medical wins FDA nod for Endo Occluder

Amsel Medical said today that it won FDA 510(k) clearance for its Amsel Endo Occluder device intended for occluding blood vessels during endoscopic procedures.

The Cambridge, Mass.-based company touted that the clearance is the third the company has received from the FDA so far for its portfolio of occluder devices.

The Amsel Endo Occluder is a mechanical occlusion clip delivered through a fine needle intended to be deployed to transfix a target vessel while clamping it shut. The device is composed of an endoscopic litigating clip applier and clips which the company said are intended or use on tubular structures or vessels.

“We are thrilled to expand the Amsel Occluder family of single-use, site-specific vascular control devices into the endoscopic and minimally invasive surgery market with this recent Pre-Marketing Notification (510(k)) by the US Food and Drug Administration. The Amsel Occluder possesses the ability to transfix and ligate a selected vessel or duct. We anticipate significant clinical interest for this innovative technology in the markets where the Amsel Occluder device is cleared for commercial distribution,” founder & prez Dr. Arnold Miller said in a press release.

Last November, Amsel Medical touted the first-in-human clinical use of its Amsel AOD2 occluder device, which took place at the NYU Langone Medical Center in New York.

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Auris Health closes $220m equity funding round

Auris Health said today it closed a $220 million equity financing round to help support its next-generation robotic surgery platform.

The Redwood City, Calif.-based company said that the round was led by Partner Fund Management and joined by newly invested Wellington Management, D1 Capital Partners and Senator Investment Group and existing investors Mithril Capital, Lux Capital and Viking Global Investors.

The funding round brings the total raised for its Monarch surgical platform up to $700 million, Auris Health said.

“The support of this group of world-class investors will be instrumental as Auris transitions into a commercial-stage company. We are pleased with our progress in launching the Monarch platform, which was initiated earlier this year. This funding will enable us to expand our commercialization efforts for endobronchial applications, and will also support our mission to pioneer the next era of medical intervention across a broader spectrum of procedures,” founder & CEO Dr. Frederic Moll said in a press release.

Auris Health’s robotic Monarch platform has FDA clearance for diagnostic and therapeutic bronchoscopic procedures. The system features a controller interface for navigating the integrated flexible robotic endoscope into the periphery of the lung and combines traditional endoscopic views with computer-assisted navigation based on 3D patient models, the company said.

In October, Auris Health, previously known as Auris Surgical Robotics, touted results from a study of its Monarch platform that indicated that the system was able to reach lung nodules and biopsy tissue with “high accuracy.”

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FDA: Updated predicate devices will improve safety, efficacy in 510(k) clearances

The FDA yesterday released a notice explaining why it believes a push for modernizing predicate devices used in equivalence testing within the 510(k) clearance pathway will improve overall safety and effectiveness.

The plan to move towards newer predicate devices is part of the federal watchdog’s larger plans to “modernize” its 510(k) pathway and make itself the gold standard regulatory body globally, which it released details on earlier this month.

In a posting released today, FDA head Dr. Scott Gottlieb said that older predicate devices may not “reflect the newest performance standards” or the agency’s most recent understanding of the benefits and risks of such devices.

“We want to create policy vehicles that will move the market towards reliance on newer predicates that reflect more modern characteristics related to their safety and performance,” Dr. Gottlieb wrote in the release.

As announced earlier this week, those policies include making information about devices cleared based on substantial equivalence to systems 10 years or older available to the public. The federal watchdog said that it will be seeking public feedback on whether 10 year old devices “are the right starting point” and if there are other actions it could take to encourage the use of modern predicates.

Between 2015 and 2018, approximately 20% of 510(k)s cleared by the FDA were based on substantial equivalence to predicates that were more than 10 years old, Gottlieb wrote in the release.

“We don’t think these devices are unsafe—they met our standards for reasonable assurance of safety and effectiveness—but we are concerned that this practice of relying on predicates that are old, and may not reflect modern performance characteristics, means that some devices are not continually improving. Yet beneficial iteration is at the heart of health technology advancements that can truly benefit patients,” Dr. Gottlieb said.

As complexity increases and interconnectivity among devices becomes more important, so to does testing devices that incorporate the latest protections against cybersecurity threats, the FDA said. Other devices, such as those that use radiofrequency technology or laser technology, “may not meet the newer consensus standards adopted by the FDA,” the federal watchdog wrote.

The agency said that it will work to identify device types where “there are clear benefits to relying on more modern technology to demonstrate substantial equivalence and obtain FDA clearance of a 510(k).”

“We want to push product developers to embrace newer predicates with improvements in technology so that patients and providers will continually have access to safer and more effective devices. At the same time that we pursue efforts to sunset older predicates, we are advancing new policies to make it more efficient to develop new predicates that reflect modern principles of safety and performance,” Dr. Gottlieb wrote in the release.

The FDA said that it will continue to update on efforts to improve its functionality.

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DexCom prices $750m debt offering

Dexcom (NSDQ:DXCM) today priced its $750 million offering of convertible senior notes due 2023 which is slated to be offered to qualified institutional buyers.

The San Diego, Calif.-based company said that it will also offer a 13-day option to buy up to an additional $100 million aggregate principal amount of notes to purchasers in the offering.

Read the whole story on our sister site, Drug Delivery Business News

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GI Dynamics inks deal to launch Indian EndoBarrier trial

GI Dynamics (ASX:GID) said today it inked a deal with Apollo Sugar, a collaboration between Apollo Health & Lifestyle Limited and Sanofi, to jointly launch a safety and efficacy study of the EndoBarrier system in India.

Through the deal, the groups will launch a clinical trial that aims to collect data from 100 randomized patients, with 75 receiving treatment with the EndoBarrier device and 25 serving as a control arm for the study.

“Apollo Sugar is pleased to work with GI Dynamics to study EndoBarrier as an innovative means of treating patients diagnosed with type 2 diabetes and obesity. Apollo Hospitals have always focused on providing advanced, safe and effective treatments to its patients. We believe EndoBarrier can provide a novel and powerful clinical tool for our clinicians, and we look forward to studying EndoBarrier in our hospitals for patients based in India and Southeast Asia,” Apollo Sugar CEO Gagan Bhalla said in a press release.

Boston-based GI Dynamics said that it is hopeful it will launch the trial during the first half of next year and close it by the end of the third quarter. The company has not yet received regulatory approval for the trial.

“We are pleased to announce this clinical trial as a first part of a partnership with Apollo Sugar to study EndoBarrier in India. We look forward to working closely with the clinical team at Apollo Sugar to first study the safety and efficacy of EndoBarrier in the region and then supply EndoBarrier to appropriate patients within the region,” GI Dynamics prez & CEO Scott Schorer said in a prepared statement.

Both GI Dynamics and Apollo Sugar said they will negotiate a joint partnership for marketing, distribution and clinical support of the EndoBarrier system for patients in India and Southeast Asia.

Earlier this month, GI Dynamics said that it closed the second tranche of a private placement, bringing in a total of $2.8 million through the issuance of CHESS Depository Interests.

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Australian TGA sets new regulations for permanently implantable medical devices

By Stewart Eisenhart, Emergo Group

The Australian government is set to begin requiring new market registrants of some implantable medical devices to provide detailed consumer information leaflets with their products on December 1, 2018 as part of a broader effort to align Therapeutic Goods Administration (TGA) regulations with the European Medical Devices Regulation (MDR).

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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BioSig inks Pure EP first-in-human study deal with Texas Cardiac Arrhythmia Institute

BioSig Technologies (OTCQB: BSGM) said today that it inked a deal with Austin’s Texas Cardiac Arrhythmia Institute at St. David’s Medical Center to launch first-in-human studies using its Pure EP system.

The Santa Monica, Calif.-based company’s Pure EP system is designed for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology procedures. The device is intended to reduce noise and artifacts to produce high-fidelity cardiac signals, which the company claims could increase the diagnostic values of the signals.

BioSig Technologies said the first-in-human studies will be focused on validating “key value propositions” of the system and to reinforce results from pre-clinical studies that have already been released.

“To better understand complex arrhythmia disease states, the ability to detect the smallest of electrical activity in various clinical situations has been a critical need for our industry. I am looking forward to the possibility that the Pure EP System will uncover these signals and advance treatment options so physicians can make more informed decisions for our patients,” study lead Dr. Andrea Natale of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center said in a prepared statement.

The launch of the studies will act as the first step in BioSig’s targeted commercial launch of the Pure EP system, which won FDA 510(k) clearance in August, the company said.

“BioSig reached another important milestone after achieving FDA clearance in August 2018 and uplisting to Nasdaq in September 2018. We opened an office in Austin, Texas, earlier this year in anticipation of our present needs, and are now focused on providing TCAI full support during the first-in-human use of our technology, which will preface our commercial launch in the U.S. in May 2019. Dr. Natale inspired the founding of our company and has chaired our scientific advisory board since 2011. We are proud to be working with Dr. Natale and his team during this important stage of our company’s growth,” chair & CEO Kenneth Londoner said in a press release.

In September, BioSig Tech said that it uplisted onto the Nasdaq Capital Market.

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