Japan clears CardioFocus’ HeartLight

CardioFocus said today it won approval from the Japanese Ministry of Health, Labour and Welfare for its HeartLight endoscopic ablation system with an indication for treating paroxysmal atrial fibrillation.

The Marlborough, Mass.-based company’s HeartLight system is designed to allow electrophysiologists to control the delivery of laser energy through direct visual guidance to isolate pulmonary veins with a high procedural flexibility. The device includes a compliant balloon to accommodate diverse PV anatomies and has a short learning curve to allow for quick adoption of the tech, the company said.

To support the newly cleared device in the region, CardioFocus said it inked a distribution partnership with Japan Lifeline, which will sell the HeartLight system through its electrophysiology division.

“By achieving approval for the HeartLight System in Japan, we are able to continue our long tradition of providing innovative products for the treatment of arrhythmias in Japan. Our trusted partnership with CardioFocus will allow us to bring this revolutionary and promising treatment option to AF patients as quickly as possible,” Japan Lifeline prez & CEO Keisuke Suzuki said in a prepared statement.

CardioFocus said it expects to launch the system in Japan during the 1st quarter of 2018 after select medical centers have received training and national reimbursement is established.

“Japan is the 2nd largest market for medical technologies in the world and the utilization of catheter ablation technologies for AF is increasing at substantial rates. It is estimated that more than 1 million people in Japan suffer from AF and together with our well-established distribution partner, JLL, we are excited to bring this clinically-validated treatment to patients in this region,” exec chair Paul LaViolette said in a press release.

Last month, CardioFocus said it launched 3 studies of its HeartLight endoscopic ablation system, touting that over 1,000 patients with atrial fibrillation will be enrolled across the studies.

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Enteromedics wins approval for Gastric Vest study in Spain

EnteroMedics (NSDQ:ETRM) said today it won approval from Spain’s Ministry of Health, Social Services and Equality to initiate a clinical trial of its Gastric Vest system in Spain.

The Gastric Vest system is a minimally invasive, laparoscopically implanted device designed to aid obese and morbidly obese patients lose weight. The device wraps around the stomach to emulate the effective of conventional weight-loss surgery, and allows for gastric volume reduction without permanent anatomical changes, EnteroMedics said.

The St. Paul, Minn.-based company is looking to enroll between 50-100 patients at 4 sites within the European Union, hoping to use the study to support CE Mark approval in the region.

“We are thrilled to have reached this significant clinical milestone, which supports our plans for CE Mark approval and takes us one step closer to bringing our Gastric Vest product to market. We believe that the Gastric Vest, which is designed to allow rapid excess weight loss over a short period of time through a minimally invasive, non-anatomy-changing procedure, will offer a novel solution for the obesity continuum of care,” prez & CEO Dan Gladney said in a prepared statement.

Earlier this month, EnteroMedics said it inked a collaborative deal with Galvani Bioelectronics, a joint venture between GlaxoSmithKline (NYSE:GSK) and Alphabet‘s (NSDQ:GOOGL) Verily Life Sciences, through which Galvani will use a modified vBloc system for pre-clinical research.

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Accuray wins FDA nod for iDMS data management system

Accuray (NSDQ:ARAY)  said today it won FDA 510(k) clearance for its iDMS data management system designed for sharing data between the company’s treatment delivery platforms.

The Sunnyvale, Calif.-based company said the iDMS system is designed to integrate data from its technology platforms, including the Radixact, TomoTherapy and CyberKnife systems, as well as the company’s Accuray Precision treatment planning and oncology information systems.

The iDMS allows users to store and manage all patient and treatment data across multiple devices to allow for more informed, efficient radiation treatments, Accuray said.

“This most recent clearance reinforces Accuray’s commitment to providing clinicians with options for seamless, fully integrated treatment planning and data management, enhancing department workflow efficiency. The common database will make it possible for clinicians to use any available Accuray treatment system, expanding patient access to the precision and treatment versatility of our advanced radiation therapy systems,” chief commercial officer Lionel Hadjadjeba said in a press release.

Earlier this month, Accuray released data from a prospective study comparing its TomoTherapy intensity-modulated radiation therapy system with Varian Medical‘s (NYSE:VAR), RapidArc radiotherapy system, touting a higher survival rate for patients treated with its TomoTherapy

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Align Technology shares dip despite Q2 beat

Shares in Align Technology (NSDQ:ALGN) fell today despite the orthodontic device maker beating expectations on Wall Street with its 2nd quarter earnings results.

The San Jose, Calif.-based company posted profits of $69.2 million, or 85¢ per share, on sales of $356.5 million for the 3 months ended June 30, for bottom-line growth of 37.9% while sales grew 32.3% compared with the same period the previous year.

Earnings per share came in well above the 73¢ consensus on Wall Street, where analysts were expecting to see sales of $343.3 million for the quarter.

“Our 2nd quarter results were better than expected across key financial metrics including revenue, volume, margins, and EPS. Q2 revenues increased 32.3% year-over-year driven by strong Invisalign case shipments across all channels and especially in the teen segment. Solid execution of our strategy and key investments continue to deliver strong growth across the board, with record Invisalign volume in almost every geography. The 2nd quarter also had an all-time high of nearly 5,000 newly trained Invisalign doctors in a quarter. Our iTero scanner business also performed well this quarter with revenues up 36.7% year-over-year,” CEO Joe Hogan said in a press release.

Align Technology updated its guidance for the coming quarter, expecting to see sales between $355 and $360 million and diluted EPS between 78¢ and 81¢.

Align Technology shares are down 3.8% today, at $166.52 as of 3:22 p.m. EDT.

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Anika names medtech veteran as new president | Personnel Moves – July 31, 2017

Anika Therapeutics (NSDQ:ANIK) last week named medtech veteran Joseph Darling as president, taking over the role from CEO Charles Sherwood. The chief exec plans to stay in the corner office as he transitions the role of president to Darling.

Previously, Darling worked as an executive in privately-held orthopedic companies. He has also held senior level executive roles at ConMed Corp. and Smith & Nephew.

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

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Why you should care about intellectual property

David Dykeman

What do early stage companies really need to focus on? Patent attorney David Dykeman says, first and foremost, that it’s intellectual property protection.

Dykeman –who co-chairs Greenberg Traurig’s global Life Sciences & Medical Technology Group – will speak at DeviceTalks Boston on October 2.

We asked him to give us some ideas on the important issues surrounding M&A and patenting.

MDO: What’s going on in M&A? What are you seeing in the medtech industry?

Dykeman: After a couple years of major consolidations in the industry, we’re seeing those work their way through the system. There is still a very strong appetite for M&A among the major players buying up these smaller and earlier stage companies. I think companies that are addressing a large market and an unmet medical need are particularly attractive for acquisition.

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

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FDA grants priority review to Indivior’s monthly buprenorphine depot

Indivior (LON:INDV) said today that the FDA accepted the new drug application for its once-monthly injectable buprenorphine depot as a treatment for adults with opioid use disorder.

The regulatory agency also granted priority review designation to the company’s NDA. Indivior’s application was supported by data from a pivotal Phase III trial, which evaluated the safety and efficacy of RBP-6000.

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

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TransEnterix touts 1st micro-laparoscopic robotic surgeries with Senhance

TransEnterix (NYSE:TRXC) today touted that its Senhance Surgical Robot system was used in the 1st 3mm micro laparoscopic robotic surgeries globally.

The surgeries were performed at France’s CHU Saint-Ètienne and at Rome’s Policlinico A. Gemelli Foundation, the Research Triangle, N.C.-based company said, by Dr. Celine Chauler, Dr. Salvatore Aletti and Dr. Gabriele Barabino.

“Patients are consistently interested in the least invasive approach possible. Utilizing 3mm microlap instruments with the Senhance Surgical Robot creates a virtually scarless approach with the precision of robotics to control such small instruments with delicate haptic force feedback,” Dr. Barabino said in a prepared statement.

The system was used in multiple general surgical and gynecologic procedures, including an ovarian cystectomy, endometrial excision, total laparoscopic hysterectomy, bilateral salpingo-oophorectomy and cholecystectomy, TransEnterix said.

“Microlaparoscopy with robotic assistance is now a reality utilizing Senhance. The use of microlaparoscopy is a growing trend, but it can be challenging to manually control and stabilize such small instruments. We believe Senhance robotic assistance can enable surgeons to expand their use of virtually scarless surgery in more patients, and creates an additional way robotics can bring value over traditional manual approaches,” CEO Todd Pope said in a press release.

In May, TransEnterix said it took out a $17 million term loan with an affiliate of Innovatus Capital Partners that it plans to use to get its Senhance robot-assisted surgery platform past the FDA.

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Boston Scientific to end Renuvia bioresorbable coronary stent program

Boston Scientific (NYSE:BSX) is looking to terminate its Renuvia bioresorbable coronary stent program, according to a Minneapolis Star Tribune report.

The move comes after new clinical studies of Abbott‘s (NYSE:ABT) Absorb bioresorbable stent indicated that use of the device resulted in a higher risk of serious adverse events compared to metal stents.

Marlborough, Mass.-based Boston Scientific said that while the bioabsorbable plastic stents do “show promise”, the company will be focusing on different areas of development.

“We’ve just decided strategically that there are bigger problems to deal with, and more socially impactful problems, like stroke, like heart failure, that need our attention. And it is better to invest in those things that will have bigger impacts than to try and overcome the technical challenges [of bioresorbable stents] in the short term,” global chief medical officer Dr. Ian Meredith told the Star Tribune.

So far, Abbott is the only medical device company in the US to have won approval for a completely bioresorbable stent with its Absorb GTI BVS device.

While the market for such stents was expected to reach the billions by 2021, data on heightened adverse events associated with the Absorb stent have damaged those prospects. A study released this month backed up earlier data, released in March, which showed increased rates of adverse events at 2-years with the Absorb when compared against metallic drug-eluting stents.

“The current findings … provide evidence beyond any reasonable doubt that Absorb BVS is inferior to new-generation [metal stents made by Abbott] on both efficacy and safety throughout 2 years. It cannot be anticipated that the potential long-term benefits of the current version of Absorb BVS will offset the excess in adverse events reported during the first 2 years,” wrote authors of a Lancet comment piece published earlier this month, according to the Star Tribune.

Data from the recent study, also published in Lancet this month, reported that while mortality rates were similar between Absorb and metal-stent patients, those treated with the Absorb showed statistically significantly higher rates of blood vessel blockage and subsequent heart attacks.

Boston Scientific is still set to release 6-month results from a trial of its Renuvia at the Transcatheter Cardiovascular Therapeutics meeting later this year, and while data looks solid, the company is still planning on cutting support for the program, according to the report.

“You have to ask the question, do we actually put the effort into studying this in much more complex patients, many of whom are at higher risk of events anyway, against a background of literature from all over the world showing consistently that this strategy is associated with worse outcomes? We think it doesn’t make sense to do this, and … we should put our energies into treating bigger problems affecting the human race in the 21st century,” Meredith told the Star Tribune.

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These wheelchair wheels function like airplane landing gear

[Image courtesy of PlastiComp]

Frog Legs has partnered with PlastiComp to make carbon fiber composite wheelchair caster wheels that function like airplane landing gear for a smoother ride.

Frog Legs wanted to switch the wheels of its wheelchairs from machined aluminum to carbon fiber composite. Mark Chelgren, the company’s founder, also wanted to create a wheelchair that had a smoother ride using a patented pivot point and wedge shaped shock absorber instead of having the wheels going up and over obstructions. The shock absorbers allow for the wheels to move over obstructions in an arc path like landing gear and make the ride smoother.

“An arc is a much more efficient movement,” said Chelgren in a press release. “But its compression zones are not linear, so instead of a traditional cylinder shaped shock absorber, Frog Legs uses a wedge shape to better handle the differential loadings from front to rear.”

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

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Myomo wins CE Mark for next-gen MyoPro powered orthotic

Myomo said today it won CE Mark approval in the European Union for its next-gen MyoPro myoelectric arm orthosis device.

Cambridge, Mass.-based Myomo develops and produces myoelectric orthotics for patients with neuromuscular disorders, including its flagship MyoPro line. The orthosis devices are non-invasive, powered braces used to support weak or deformed arms and hands to allow for functional activity.

Myomo touted the MyoPro as the only lightweight wearable device designed to restore function to paralyzed or weakened arms and hands in individuals who have suffered a stroke, spinal cord or nerve injury or other neuromuscular disability.

“The MyoPro powered brace allows individuals suffering from paralysis or stroke to perform routine daily activities. Gaining CE Mark approval is an important milestone for our Company and for the many people in Europe who will now be able to experience the benefits of MyoPro as they struggle with upper limb paralysis. We are currently working with our partner Ottobock to plan our European launch beginning in Germany. Myomo recently conducted sales and clinical training for Ottobock staff, which has begun evaluating patients for the MyoPro device. With revenue of over a billion Euros and operations in 50 countries, Ottobock is a global market leader in technical orthopedics and prosthetics,” CEO & chair Paul Gudonis said in a prepared statement.

Last month, Myomo released results from an investigator-led study of its MyoPro myoelectric orthotic, touting reduced upper extremity impairment with the use of the device.

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This artificial heart is made from silicone

[Image from ETH Zurich]

Researchers have developed an artificial heart made of silicone that beats almost like a human heart, according to new research from Eidgenössische Technische Hochschule (ETH).

The ETH researchers set out to develop a heart that looks like the real time and functions like one too. It was designed by Nicholas Cohrs, a doctoral student in the group, and was led by Wendelin Stark, professor of functional materials engineering at ETH Zurich

Currently, blood pumps are likely to have complications, according to the researchers. The new model tries to eliminate complications that arise from mechanical parts in other blood pumps.

“Our goal is to develop an artificial heart that is roughly the same size as the patient’s own one and which imitates the human heart as closely as possible in form and function,” said Cohrs in a press release.

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

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InVivo temporarily halts Inspire study enrollment after patient death

InVivo Therapeutics (NSDQ:NVIV) said today it is temporarily suspending enrollment in its Inspire trial of its neuro-spinal scaffold after its most recent patient, implanted last month, passed away suddenly following hospital discharge.

While the death was deemed to be unrelated to the neuro-spinal scaffold or the implantation procedure, the company said it was initiating a temporary enrollment halt while it discusses possible patient enrollment criteria changes with the FDA.

Due to the enrollment halt, Cambridge, Mass.-based InVivo said it expects it will complete enrollment for the trial during the 1st half of 2018, with a slated submission seeking humanitarian device exemption from the FDA during the 2nd half of 2018.

“Our thoughts and condolences are with the patient’s loved ones at this difficult time. We remain committed to monitoring carefully all aspects of the Inspire study to ensure the ongoing safety of subjects. Regarding the enrollment halt, we are working toward an expeditious resolution. Based on the compelling clinical results to date, particularly the 2 most recent AIS conversions, we hope to reopen enrollment as soon as possible,” CEO Mark Perrin said in a press release.

The company’s neuro-spinal scaffold is a novel, biodegradable device designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.

InVivo updated on patient conversions within the trial, saying that 1 patient had improved from a complete AIS A SCI to motor complete AIS C SCI at a 1 month visit, while a 2nd patient improved from a complete AIS A SCI to sensory incomplete AIS B SCI at their 6-month visit. A total of 6 of 11 patients in the trial have had an AIS grade improvement at the 6-month primary endpoint visit, the company said.

A patient who had shown to have initially converted from a complete AIS A SCI to sensory incomplete AIS B SCI at 2 months reverted back to AIS A at 3 months, but then was deemed to have converted from AIS A to AIS B at 6 months, the company said.

“This patient has demonstrated motor improvements from baseline assessments, and the conversion to AIS B at the 6-month visit is encouraging,” site principal investigator Dr. Travis Dumont of Banner – Univeristy Medical Center Tucson said in a prepared statement.

A separate patient was shown to have converted from AIS A SCI to motor incomplete AIS C SCI between their discharge from the hospital and 1-month visit. The company said that the patient was assessed to have a T6 neurological level of injury, and that they were the 2nd to have reached AIS C motor incomplete classification at the 1-month evaluation.

“A conversion to AIS C at one month for a patient with a T6 level of injury is rare. I look forward to continuing to track the patient’s progress and hope that the patient continues to show signs of neurological recovery,” site principal investigator Dr. Terrence Julien of Pittsburgh, Penn.’s Allegheny General Hospital said in a prepared statement.

Earlier this month, InVivo said it added Stanford Medicine as the 34th clinical site in the Inspire study of its neuro-spinal scaffold.

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Injectable, extended-release bipolar drug wins FDA nod

Otsuka Pharmaceutical (TYO:4578) and Lundbeck said last week that its extended-release injectable aripiprazole suspension, Abilify Maintena, won FDA approval as a maintenance monotherapy for adults with bipolar I disorder.

The once-monthly intramuscular formulation was created by Otsuka and co-developed and commercialized with Lundbeck, the companies reported.

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

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Medtronic wins CE Mark for CoreValve Evolut Pro

Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its CoreValve Evolut Pro transcatheter aortic heart valve, indicated for the treatment of severe aortic stenosis for symptomatic patients at intermediate, high or extreme risk for open heart surgery

The CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based Medtronic said.

“We are excited to introduce the next evolution of our Evolut TAVI platform to provide physicians in Europe with a comprehensive portfolio to address their patients’ needs,” heart valve therapies GM Rhonda Robb said in a press release.

Medtronic said that the clearance was supported by data from a clinical study of the CoreValve Evolut Pro, which met its primary endpoint at 30 days and reported a 98.3% rate of survival and a 1.7% rate of disabling stroke. A total of 72.4% of patients in the trial experienced trace amounts of paravalvular leakage or none at all, with no incidents of moderate or severe PVL reported at 30 days.

The Evolut Pro system is designed to be delivered through the EnVeo R delivery catheter system and is indicated for vessels as small as 5.5mm, Medtronic said. The CoreValve Evolut Pro is now available in Europe in 23mm, 26mm and 29mm sizes, the company said.

“The Evolut PRO valve has shown impressive clinical outcomes, with low paravalvular leak and pacemaker rates. With its ease-of-use and deliverability, the Evolut Pro valve will bring TAVI practice to a higher level, and I look forward to seeing it utilized in patients across Europe,” Dr. Nicolas Van Mieghem of Rotterdam, The Netherlands’ Erasmus Medical Center said in a prepared statement.

Medtronic won FDA approval for the Evolut Pro in March.

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NantCell takes on troubled CytRx chemotherapeutic

NantCell, one of controversial biotech entrepreneur Patrick Soon-Shiong’s many businesses, said last week that it inked a deal to acquire CytRx‘s (NSDQ:CYTR) aldoxorubicin cancer drug.

The compound has faced several obstacles in clinical trials, including when it missed the primary endpoint of a late-stage clinical trial, failing to help patients with second-line soft tissue sarcoma in a significant way compared to a control therapy.

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

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Cantel Medical to buy BHT Group for $60m

Cantel Medical (NYSE:CMN) said today it inked a definitive agreement to purchase German endoscope reprocessor BHT Hygienetechnik Holding for $60.8 million.

BHT Group has approximately 100 employees and provides automated endoscope reprocessing alongside related equipment, services and flexible endoscope repairs, Little Falls N.J.-based Cantel Medical said. Over the past year, BHT Group reported revenues of $24.5 million.

“Establishing leadership in our international markets is a key component of our strategy and this milestone will help us achieve this goal. The addition of BHT Group will enable us to become the market leader in automated endoscope reprocessors in Germany. We’re excited to combine BHT’s expertise and the talent with our Cantel Germany operations. Together we will deliver a market leading portfolio of endoscopy products and services to our customers. This important milestone will also position us well for future growth in Germany as well as add new products with strong global potential,” prez & CEO Jorgen Hansen said in a prepared statement.

Cantel Medical said it expects the acquisition to be accretive ot non-GAAP earnings per share during its current fiscal year, and accretive to GAAP EPS in its fiscal year ending July 30, 2019, and beyond. The acquisition is expected to close at the end of August.

“BHT Group is an excellent strategic fit with our endoscopy division and aligns well with the growth aspirations outlined in our strategic plan Endodry Cabinets are an essential part of our future growth profile, and integrating this franchise into our portfolio will enable us to continue to innovate critical infection prevention products worldwide,” endoscopy division prez Dave Hemink said in a press release.

In April, Cantel Medical said it closed its buy of endoscopy business assets from Australian distributor CR Kennedy.

The assets picked up by Little Falls, N.J.-based Cantel include its Mediators-branded automated endoscope reprocessors, chemistries and procedure room products. The sale also includes a full sales and service organization from CR Kennedy, the company said.

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Titan Pharmaceuticals lands $10m debt facility

Titan Pharmaceuticals (NSDQ:TTNP) said last week that it inked a $10 million venture loan and security deal with Horizon Technology Finance Corp.

The first $7 million tranche was triggered after the groups inked a deal, Titan reported, and a second option of $3 million is available to the California-based company until March 31, 2018, contingent upon certain revenue and development milestones.

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

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Cardinal Health closes $6B buy of Medtronic patient care, DVT and nutritional insufficiency biz

Cardinal Health (NYSE:CAH) said today it closed its $6.1 billion acquisition of Medtronic‘s (NYSE:MDT) patient care, deep vein thrombosis and nutritional insufficiency business.

Dublin, Ohio-based Cardinal Health said that the acquisition was funded through a combined $4.5 billion in new senior unsecured notes alongside existing cash and borrowings from credit facilities.

The deal includes a total of 23 product categories across multiple market sites of care, Cardinal Health said, including the brands Curity, Kendall, Dover, Argyle and Kangaroo.

Cardinal Health said it expects the acquisition to be accretive to non-GAAP diluted earnings per share by more than 21¢ per share during its next fiscal year, including up to $100 million of inventory step-up costs during the 1st few quarters after the deal closes.

The company said it expects the deal to be accretive to non-GAAP EPS by more than 55¢ per share by its fiscal 2019 year, and increasingly accretive moving forward.

The company said that the newly acquired businesses will become part of its Cardinal Health Medical segment, and that integration and transition work have begun with a slated completion at 18 months out.

“This business provides our customers with more product offerings and includes some well-established brands that fit naturally within our portfolio and are complementary to our current medical products business. We know these products and many of the employees well, and have seen that our team members share a common commitment to quality, customer service and the patients who we all ultimately serve. We are extremely excited about welcoming our new colleagues from around the world to Cardinal Health,” Cardinal Health CEO George Barrett said in a press release.

Cardinal Health shares have gained 0.5% today, at $78.02 as of 10:08 a.m. EDT.

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QT Vascular launches pivotal trial for drug-coated peripheral balloon

QT Vascular said today that it launched the U.S. pivotal trial for its Chocolate Touch drug-coated peripheral balloon in the hopes of winning FDA approval. The device won CE Mark clearance in September 2015.

The trial is slated to compare the safety and effectiveness of the Chocolate Touch balloon with Bard‘s(NYSE:BCR) Lutonix drug-coated balloon catheter. The company said it plans to evaluate non-inferiority and superiority of its DCB over Bard’s device.

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

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Aerie inks deal for implantable drug-delivery system

Aerie Pharmaceuticals (NSDQ:AERI) said today that it inked a collaborative R&D and licensing agreement with DSM to develop an implantable drug-delivery system for patients with glaucoma and other retinal diseases.

DSM has reportedly developed an injectable drug-delivery fiber using polyesteramide polymers that has proven successful in preclinical work with Aerie’s compounds.

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

 

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Patient Reps: Bringing the voice of patients to FDA

By: Jack Kalavritinos

At FDA we never lose sight of the fact that the work we do in evaluating and approving new medical products is done to benefit patients.

Increasingly, that means taking into account the views and expertise of patients and their caregivers, because they provide a unique voice and perspective and know best what they are living with on a day-to-day basis. Earlier this month, for instance, we announced the creation of the first advisory committee made up solely of patients and caregivers, who will provide advice on complex issues related to medical devices.

Another way we incorporate the patient viewpoint is through FDA’s Patient Representative Program. This program brings patients – and their caregivers – and the extraordinary breadth of knowledge and personal experience in more than 300 diseases and conditions they possess, directly into the regulatory medical product development and review process. They serve on 47 FDA Advisory Committees and panels to advise on drugs, devices and biologics currently being considered for approval or clearance. They also serve as a consultant for the review divisions (doctors and scientists who review data to determine whether the medical product’s benefits outweigh the potential risks), and as presenters at FDA meetings and workshops on disease-specific or regulatory and health policy issues.

Every year our team at FDA’s Office of Health and Constituent Affairs brings new FDA patient representatives to the Washington, D.C. area, for training and orientation. They receive briefings on everything from medical product review policies and clinical trials to the life cycles of drugs, biologics, and devices, and even a brief primer on statistical analysis.

Without a doubt, the most moving moments of the recently completed two-day workshop  were when the patient representatives told their own stories, how they are making a difference in so many lives as advocates for their own patient communities, and explaining why they had decided to make the commitment to become patient reps. One was more compelling than the next. Here are some of their stories:

• A woman with fibromyalgia who said she joined the program “to give a voice to those who suffer with chronic, life-altering conditions.”  She believes her training in qualitative research, combined with her personal experience with her disease, will help her listen to and understand patient experiences and to “sort out the ‘noise.’”

•  A caregiver whose husband survived for three years after being diagnosed with glioblastoma multiforme, a form of brain cancer. During that period, he received four surgeries and took 15 different chemotherapy drugs. She became a patient advocate as a result of her experience so she could be involved in the process of finding new treatments for “this daunting disease.” She also works with other caregivers to help them cope with the diagnosis. As she explained, “Being able to talk to someone who has experienced this same disease helps to reduce their level of anxiety and some of the unknowns that accompany this diagnosis.”

• A patient with schizoaffective disorder who talked about how her disease first appeared when she was in college, when the voices she would hear interfered with her ability to learn and function. But with proper treatment, and incredible discipline and support, she was able to learn to control her disease and not let it take over her life. Today, she is a mental health therapist who works to combat stereotypes that prevent psychiatric patients from getting the help they need, when they need it. Her goal has been “to put a face to those of us who struggle with psychosis, but yet are seen as being ‘functionally well.’”

• A father and uncle to two women with Friedreich’s ataxia, a life-shortening genetic mitochondrial nerve disorder that has no treatment. He has watched as his daughter, now 31, has become a quadriplegic. As he said with incredible honesty and pain, “she will die soon.” But he also has turned his pain into action. In addition to assisting his daughter and niece, he also has lent his energy to helping others with the disease and to generating attention and resources for finding a treatment. He became a patient representative, in part, he explained, so that he “could be at FDA on the day a treatment needs his yes or no vote.”

Space prevents including every one of their stories, but each of these remarkable individuals offered a compelling history of courage. All are committed to fighting the disease that had so directly affected them, whether as a patient or a caregiver. But, in a comment that could be applied to all of them, one woman noted, she “works hard to not let my identity be defined by my illness.” They do this, remarkably, by turning their focus outward, rather than inward, and using their strength and expertise to the benefit of others.

This understated, but courageous, spirit is echoed in one way or another by each of FDA’s patient representatives. We want to thank each of these individuals for their inspiring commitment — to the FDA, to better health, and for their role in these critical public health efforts.

Jack Kalavritinos is FDA’s Associate Commissioner for External Affairs

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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Invacare shifts Rea wheelchair production from Sweden to France

Invacare (NYSE:IVC) said today it is transferring the production of its Rea manual wheelchairs from its Dïo, Sweden facilities to its wheelchair manufacturing facilities in Fondettes, France, beginning next January.

Elyria, Ohio-based Invacare said the move will allow the company to “better optimize its wheelchair manufacturing facility” in Fondettes, and allow the Dïo facility to focus on the production of beds for the Nordic market and its distribution center for lifestyle products.

“As we continue to make progress in phase 2 of our strategic transformation, we will continue to leverage our existing global infrastructure and further increase efficiencies. By transferring wheelchair production from Dïo to Fondettes, we are able to create a European wheelchair center of excellence that is centrally located to our European customers. We will continue to stay close to our Nordic customers and maintain the on-time and reliable delivery that they have come to expect from us,” prez & CEO Matthew Monaghan said in a press release.

The transfer is expected to generate an incremental $1.6 million in annualized pre-tax savings in its European business segment, the company said, but will incur restructuring charges of approximately $1.4 million, including the severance of approximately 70 employees.

Earlier this week, Invacare said it received notice from the FDA that it can resume wheelchair production operations at its Elyria, Ohio-based manufacturing facility.

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Report: Amazon developing stealthy healthcare development lab

Amazon (NSDQ:AMZN) reportedly has a healthcare skunkworks lab working in areas including electronic medical records and telemedicine, dubbed 1492, according to a CNBC report.

The team, headquartered in Seattle, is engaged in both hardware and software products, according to the report.

Amazon’s secretive team is reportedly considering development in fields that would see them pushing and pulling data from electronic medical record systems, possibly angling to make that data available to both consumers and doctors.

The team is also working to build a platform for telemedicine to create virtual-physician consultations with doctors, according to CNBC.

Projects are taking into account Amazon’s existing tech, including the Echo and Dash Wand. Amazon’s Echo unit and its associated Alexa voice assistant have already been used in a handful of products in the healthcare field and in clinical studies.

Amazon has not yet responded to requests for comment on the matter.

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UK-based Surgical Innovations to buy Elemental Healthcare for $12m

UK-based surgical instrument maker Surgical Innovations is looking to purchase UK NHS medical product supplier Elemental Healthcare for $12.4 million (GBP £9.4 million), according to a Yorkshire Post report.

Elemental Healthcare operates as an exclusive distributor of Surgical Innovations products, according to the report, with the acquisition expected to have an immediate positive impact on SI’s margins and profitability.

Berkshire-based Elemental Healthcare has 19 employees, and is owned by co-founders Adam Power and David Marsh, who will join the board of Surgical Innovations as part of the deal.

“Coming together was the natural next step for 2 businesses that have had such a long-standing and​ ​fruitful partnership​. ​​Adam and David, the​ ​principals at Elemental, have a great pedigree in the medical device section and ​we ​look forward to benefiting​ ​from their insights into our new product initiatives and business development here and abroad,” Surgical Innovations exec chair Nigel Rogers said, according to the Yorkshire Post.

Surgical Innovations said it is looking to raise $7.2 million (GBP £5.5 million) through a new offering, alongside a $3.3 million (GBP £2.5 million) debt facility to help pay for the acquisition, according to the paper.

“There are clear and obvious benefits to margins and​ ​earnings as we add a highly profitable and cash generative business to the group, but this also provides us with access to an experienced direct sales force and the new products distributed by Elemental will widen​ ​the range of products on offer to surgeons in the NHS and UK private hospitals. All acquisitions have some integration risks attached to them, but having worked with the Elemental team​ ​and having such a high level of inter-dependency we expect this will ease the integration process,” Rogers said, according to the report.

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Mediware taps ex-Optum exec Miller for CEO | Personnel Moves July 28, 2017

Healthcare tech group Mediware Information Systems said it tapped former United-Health Group subsidiary OptumInsight chief exec Bill Miller as its new CEO, replacing Kelly Mann, who has served in the corner office since 2007.

Mediware said that Miller will work with the Lenexa, Kansas-based company’s management to “build and accelerate the company’s platform” to expand its footprint in the alternate care and human and social services market.

“I want to thank the team at Mediware for their dedication, innovation, and hard work over the last several years. Mediware is a best-in-class company and it’s been a privilege to have played a leading role. Bill is an accomplished industry executive with valuable operational skills and creative insights. With his leadership and the ongoing support of our partners at TPG, I am confident that Mediware is well positioned for its next chapter of growth,” former CEO Mann said in a press release.

Miller has more than 20 years of experience in healthcare and technology, and during his time at OptumInsight saw revenues grow from $1.5 billion to $5 billion. Prior to his time at OptumInsight, Miller served as tech VP at Cerner.

“Having spent my entire career in the healthcare and technology industries, I have known Mediware as an industry leader with a deep understanding of the marketplace and an ongoing commitment to quality and client service. I am excited about their strong position in the expanding markets they serve, and look forward to working with TPG and the Mediware team to build on the momentum that the company has achieved to-date,” Miller said in a prepared statement.

 OrthoAccel names Josza as CEO

OrthoAccel Technologies said this week it named former Zimmer Biomet dental GM David Josza as its new CEO, effective August 1.

Josza spent 14 years at Biomet before it was acquired by Zimmer in 2015, when Josza was tapped to lead the acquisition integration, Houston-based OrthoAccel said in a press release.

“OrthoAccel is a market leader in accelerated orthodontic technology and I am delighted to lead the company’s next phase of growth and innovation. This is an exciting stage in OrthoAccel’s trajectory and, based on the feedback of orthodontists and patients who have experienced the new AcceleDent Optima, there is significant opportunity for growth ahead for this best-in-class treatment technology,” Josza said in a prepared statement.

“We are excited to welcome David and recognize that his in-depth experience in dental and medical industries, combined with his many successes as a strategist and business developer, provide an excellent leadership platform for his role at OrthoAccel Technologies,” board chair Brian Smith said in a press release.

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 JustRight Surgical taps ViroCyt founder Kline as CEO

JustRight Surgical said yesterday it tapped Robert Kline as its new chief executive, replacing co-founder and CEO Russ Lindemann, who is retiring.

Prior to joining JustRight Surgical, Kline served as prez & CEO of biotech tools company ViroCyt which was acquired by Sartorious AG last July. Kline also served as founder, prez and CEO of Medivance, which was acquired by C.R. Bard in 2011 for $260 million.

“JustRight Surgical is gaining momentum in the marketplace and due to personal considerations, I felt it was an ideal time to reduce my involvement with the company to my Board responsibilities,” Lindemann sad in a press release.

“I am excited to join the JustRight team and the opportunity to build upon the exceptional accomplishments of Russ and the founding team,” Kline said in a prepared statement.

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 Zimmer Biomet group prez Johnson jumps ship for private equity

Zimmer Biomet (NYSE:ZBH) said today its spine, dental, craniomaxillofacial and thoracic biz unit prez Adam Johnson is resigning, effective September 1.

Johnson will be leaving to ‘pursue his professional goals that include a career in private equity,” the Warsaw, Ind.-based company said, after having helped with the integration of LDR and the placement of new leaders in the company’s spine and dental business.

Current spine, dental, craniomaxillofacial and thoracic biz finance vp Chris Jefferis will operate as interim group prez until a permanent successor is named, Zimmer Biomet said.

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 G&L Scientific taps Fresenius vet Flanagan as clinical ops VP

Healthcare, clinical and scientific consulting provider G&L Scientific said today it appointed former Fresenius senior director Brigid Flanagan as its clinical operations VP.

During her time at Fresenius Medical Care North America, Flanngan set up and managed a CRO dedicated specifically to renal research, G&L Scientific said.

“We are very happy that Brigid is joining G&L Scientific. The experience that she has gained over 20-plus years in clinical operations will be extremely valuable to our clients. The fact that G&L was able to attract and secure such a talented and experienced individual speaks volumes for the reputation of our company for delivering world-class services,” CEO Stephen Loughrey said in a press release.

Read more

• Endogastric Solutions taps new sales, marketing VPs
• Myomo expands management team
• Ventripoint taps Hirson as dev & ops VP
• Wound Management Tech prez Hutchinson retires
• Millstone Medical adds 2 to exec team

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C.R. Bard faces DoJ FCA probe, posts Q2 earnings

C.R. Bard (NYSE:BCR) said today that the US Department of Justice is investigating possible False Claims Act violations related to the sales and marketing of its FloChec and QuantaFlow devices, alongside releasing Q2 earnings which topped expectations on The Street.

The Murray Hill, N.J.-based company said this month it was served with a “civil investigative demand” from the DoJ, which was seeking documents and information relating to possible FCA violations, according to an SEC filing.

Bard said it was cooperating with the requests, but that it could not give any solid assurances that the investigation and proceedings would not have a material adverse effect on the company’s business, results, financial condition or liquidity.

In its earnings report, the company reported profits of $139.7 million, or $1.86 per share, on sales of $979.7 million for the 3 months ended June 30, seeing the bottom-line shrink 12.2% while sales grew 5.2% compared with the same quarter during the previous year.

Adjusted to exclude 1-time items, earnings per share were $2.92, just ahead of the $2.84 consensus on The Street, where analysts were looking for sales of $979.7 million, just in line with Bard’s posted revenue.

“We continue to see strong, balanced growth across our portfolio and geographies. Half-way through 2017, each of our businesses has performed at or above the top of our forecasted constant currency revenue growth ranges for the full year. In the second quarter we reached a new milestone, with revenue from emerging markets now representing 12 percent of total company revenues. We are pleased with the continued momentum of our global business as we prepare to merge with Becton, Dickinson and Company in the fourth quarter of 2017,” CEO & chair Timothy Ring said in a press release.

Bard reiterated its guidance for the full 2017 fiscal year, expecting to see earnings per share between $11.70 and $11.90 with sales increasing between 6% and 7% compared to 2016.

Shares in C.R. Bard have stayed steady today in light of the news, down 0.1% at $321.04 as of 2:04 p.m. EDT.

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Omnicell shares surge after Q2 beat

Shares in Omnicell (NSDQ:OMCL) soared today after the company beat expectations on Wall Street with its second quarter results.

The Mountain View, Calif.-based company posted profits of $837,000, or 2¢ per share, on sales of $180.9 million for the 3 months ended June 30, for sales growth of 4.6% compared with the same period last year.

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

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Slug slime inspires new surgical glue

(Reuters) – Scientists have developed an experimental surgical glue inspired by the mucus secreted by slugs that could offer an alternative to sutures and staples for closing wounds.

While some medical glues already exist, they often adhere weakly, are not particularly flexible and frequently cannot be used in very wet conditions.

To get around those problems, a group of scientists from Harvard and other research centers decided to learn from slugs, which – as well as making slime to glide on – can produce extremely adhesive mucus as a defense mechanism.

The slugs’ trick is to generate a substance that not only forms strong bonds on wet surfaces but also has a matrix that dissipates energy at the point of adhesion, making it highly flexible.

The man-made version of this tough adhesive is based on the same principles and in a series of experiments reported in the journal Science on Thursday it was shown to adhere strongly to pig skin, cartilage, tissue and organs. It also proved non-toxic to human cells.

In 1 test the new glue was used to close a wound in a blood-covered pig’s heart and successfully maintained a leak-free seal after the heart was inflated and deflated tens of thousands of times.

In another case it was applied to a laceration in a rat’s liver and performed just as well as a hemostat, a surgical tool often used in operations to control bleeding.

“There are a variety of potential uses and in some settings this could replace sutures and staples, which can cause damage and be difficult to place in certain situations,” said researcher David Mooney, professor of bioengineering at Harvard.

Mooney and colleagues envisage the new adhesive will be made in sheets and cut to size, although they have also developed an injected version for closing deep wounds. The injection would be hardened using ultraviolet light, like dental fillings.

It is not the 1st time that scientists have taken inspiration from nature to devise a better medical adhesive.

Four years ago, another research group developed a glue inspired by the underwater sticking properties of mussels, but Mooney thinks slugs win hands-down in terms of stickiness and flexibility.

The scientists are applying for patents, although it will require a commercial company to then license the technology and take it into the next phase of human clinical trials.

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Haemonetics wins FDA 510(k) for NexSys PCS plasmapheresis system

Haemonetics (NYSE:HAE) said today it won FDA 510(k) clearance for its NexSys PCS plasmapheresis system designed for collecting blood plasma.

The NexSys PCS includes bi-directional connectivity to the Braintree, Mass.-based company’s NexLynk DMS donor management system, and allows for automated collection procedure programming and automated end of procedure documentation.

“NexSys PCS is designed to increase productivity and improve quality and compliance in plasma collection centers. Each of these benefits is noteworthy and when combined we believe will unlock meaningful value for our customers,” CEO Christopher Simon said in a press release.

Haemonetics said it plans to immediately begin a limited production of the NexSys PCS systems while pursuing other regulatory clearances for product enhancements.

In May, Haemonetics released 4th quarter and full 2017 fiscal year earnings results that beat expectations on Wall Street.

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Cyber attack stalls manufacturing for Merck, narrows outlook

Merck (NYSE:MRK) narrowed its full-year earnings outlook while announcing its second quarter results today. The company revealed that an international cyber attack, which hit the drugmaker in June, halted some of its manufacturing operations.

While touting its second quarter financial results, Merck said that it doesn’t yet fully comprehend the magnitude of the disruption caused by the cyber attack and that it is still restoring its operations.

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

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7 medtech stories we missed this week: July 28, 2017

[Image from unsplash.com]

From Accenture’s AI-powered app to help the visually impaired to Rayovac getting clearance from Health Canada, here are seven medtech stories we missed this week but still thought were worth mentioning.

1. Accenture touts AI-powered app for visually impaired

Accenture announced in a July 28 press release that it has developed an artificial intelligence–powered way to help the visually impaired experience their surroundings. The method involves a program called Drishti that is a smartphone-based assistant that uses AI technology like image recognition, natural language processing and natural language generation capabilities. All of those combined help describe the world around the user. It is able to tell the user the number of people in a room, their ages, gender and emotions as well as narrate books and documents like money.

2. Quantel Medical wins FDA nod for photocoagulator

Quantel Medical got approval from the FDA for its Easyret fully integrated 577nm yellow photocoagulator, according to a July 27 press release. The photocoagulator is designed to treat certain forms of macular edema and peripheral retinal pathologies. It has a wide range of settings to treat the pathologies and allows surgeons to select a Multispot mode to target multiple areas. It also has a SubLiminal mode that allows it to perform short pulses to manage the thermal effect on targeted tissues.

3. Orofacial Therapeutics wins CE mark

Orofacial Therapeutics announced in a July 27 press release that its QuickSplint interim oral appliance has received CE mark approval. The QuickSplint can be fabricated quickly and easily during dental procedures. It is one of the only applications that can be used for two to four weeks. It gives patients same-day treatment for acute jaw and orofacial pain, diagnostic aid for bruxism and offers a post-op healing aid after periodontal surgery, oral surgery and other long dental procedures.

4. 4WEB launches 3D-printed lateral spine device

4WEB Medical has announced that the first surgeries using its Lateral Spine Truss System were successfully performed, according to a July 27 press release. The 3D printed device was designed to solve surgical problems that come with legacy annular implant designs. With its unique bi-convex dome, loads are distributed across a large surface. It has three times more surface topography than other spine implants.

5. Cogstate wins FDA 510(k) for Cognigram cognitive assessment

Cogstate announced in a July 27 press release that its Cognigram cognitive assessment system has received FDA 510(k) clearance. The device is classed as a Class II Exempt Medical Device. The clearance allows for the company to market the device in the U.S. Cognigram is a digital cognitive assessment tool that can be done in a clinic or at home.It is designed to aid healthcare professionals with objective measurements of cognition for people who are ages 6 through 99 years old.

6. Agfa gets 510(k) clearance for Xero enterprise imaging platform

Agfa Healthcare has received FDA 510(k) clearance for its Xero Xtend functions of its Enterprise Imaging zero-footprint viewer, according to a July 27 press release. The device has been cleared for use on desktop devices and adds 3D processing and advanced clinical applications to the Xero Viewer.

7. Rayovac wins Health Canada nod for hearing aid batteries

Rayovac announced in a July 27 press release that its zinc air hearing aid batteries are the first hearing aid batteries to receive a medical device license from Health Canada. Hearing aid batteries are considered Class II medical devices and require special licensing to be marketed.

Here’s what we missed last week.

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Integer misses expectations on Q2 profits, but grows revenue

Medical device contract manufacturing giant Integer Holdings Co. reported a mixed bag when it came to second-quarter results.

Nearly two years after Greatbatch and Lake Region Medical merged to create Frisco, Texas–based Integer, sales are growing, but second-quarter profits did not meet analysts’ expectations, according to earnings released yesterday evening.

Integer earned $3.0 million, or 9 cents per share, off $362.7 million in revenue for the quarter ended June 30, versus a loss of $770,000, or 3 cents per share, off $348.4 million in revenue for the same quarter a year ago.

Adjusted second-quarter net income was 62 cents per share. Analysts on average expected 67 cents per share earnings, according to Yahoo! Finance.

Gary Haire, Integer’s EVP and CFO, told analysts during a conference call that earnings have improved amid “reduced spending on integration, restructuring, and consolidation and optimization activities.”

“These improvements were offset by the unfavorable foreign exchange impact of $5.5 million in the quarter and a $5 million impairment of a minority investment that was made back in the 2008 and 2009 time frame,” Haire said during the call, which was transcribed by Seeking Alpha.

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

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NuVasive shares drop amid mixed Q2 earnings, reorganization efforts

Shares in NuVasive Inc. (NSDQ:NUVA) fell today after the medical device maker posted 2nd quarter earnings that beat earnings per share expectations but fell short on sales with shrinking profits compared to the previous year, alongside announcing a number of changes to its executive roster.

The San Diego, Calif.-based company posted profits of $12.7 million, or 22¢ per share, on sales of $260.6 million for the 3 months ended June 30, seeing the bottom-line shrink 58.1% while sales grew 10.3% compared with the same period in the previous year.

Adjusted to exclude 1-time items, earnings per share were 46¢, just ahead of the 44¢ consensus on The Street, where analysts were expecting to see sales of $262 million for the quarter.

“NuVasive delivered better than expected operating profitability and earnings per share results in the 2nd quarter 2017, along with continued strength across our international business, growing at more than 20% for the 3rd quarter in a row. In addition, several of our industry-disrupting technologies completed alpha and beta testing this quarter and will commercially launch over the next few months, giving surgeons and patients access to some of the most innovative technologies to address spine and trauma conditions, as well as radiation reduction in the operating room,” chair & CEO Gregory Lucier said in a prepared statement.

NuVasive reiterated its guidance for the full 2017 fiscal year, expecting to see sales of $1.1 billion and non-GAAP earnings per share of $2.00.

Along with its earnings results, the company announced a number of personnel changes, the foremost being the departure of prez & COO Jason Hannon who is stepping away to “pursue other interests.”

NuVasive said 12-year company vet Hannon would stay on with NuVasive until the end of the year to serve in an advisory capacity. With his departure, the company announced a number of “organizational changes” as it seeks to align its strategy, technology and marketing and integrate US and international sales teams.

The company also said its chief financial officer Quentin Blackford would resign, effective Aug. 25, to pursue “another opportunity outside the spine industry.” Blackford will stay on with the company during his transition period, the company said, which clarified that the resignation was not related to any disputes, disagreements or matters related to financial reporting.

Independent board member Vickie Capps will “provide guidance and support to the company’s financial organization during the transition period,” the company said.

As part of the reorganization, the company said it is promoting Matt Link to the newly-created position as exec VP of strategy, technology and corporate development. NuVasive said it also appointed Skip Kiil as global commercial exec VP and Steve Rozow as global process transformation exec VP

“As the innovation pioneer and largest, pure-play spine technology company, NuVasive continues to deliver significant value to its customers and shareholders. With incredible opportunities ahead, we are taking steps to refine the company’s operating structure to tightly align strategy, product development and marketing and integrate our global commercial channels, while scaling global operations to best address the growing needs of our partners and patients. Since becoming CEO over 2 years ago, I have been working with our board to build a world-class leadership team to support our revenue growth and profitability goals. Together, we are executing against our 5-year strategic plan and building a deep bench of talent, positioning us well to execute against our short- and long-term initiatives. I remain more confident than ever in our company’s position to take on the next $1 billion in growth,” CEO Lucier said in a press release.

Shares in NuVasive have significantly dropped in early-hours trading, down 11.8% at $67.82 as of 11:17 a.m. EDT.

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Quantitative Insights wins FDA de novo nod for QuantX machine learning cancer diag

Quantitative Insights said yesterday it won FDA de novo clearance for its QuantX Advanced computer-aided diagnosis platform designed for evaluating breast abnormalities, touting it as the 1st such program to integrate machine learning.

The Chicago-based company said the software platform includes embedded tools, including its QI Score and Similar Case Database Compare, which provide similarity assessment against a “robust database of abnormalities with clinically documented pathology.”

QI said that the system has resulted in a new device Indication for Use through the FDA’s de novo pathway.

“QuantX provides valuable additional information for multi-modality breast imaging decision support. With a single click, we have access to advanced machine learning analytics showing how the abnormality being analyzed compares to similar abnormalities with known pathology. This impacts a radiologist’s confidence and improves reading time, and now we have clinical-study proof that it also significantly improves diagnostic performance,” QI medical advisor Dr. Gillian Newstead said in a press release.

The QuantX platform includes licensed technology from Maryellen Giger’s research labs at The Univeristy of Chicago, which QI said it has had a long-standing collaborative relationship with.

“Quantitative Insights has demonstrated that they can successfully take meaningful clinical innovations from research labs and clinics, develop them into products, take them through the regulatory process, and to the market,” QI scientific advisor Maryellen Giger of The University of Chicago said in a preapred statement.

The company said it is pursuing a product launch in the US, as well as distribution partners for the US and international markets.

“This clearance marks a true breakthrough in the diagnosis and management of cancers, starting with breast. In our FDA clinical study, QuantX was shown to improve the diagnostic performance of radiologists, enabling faster and more accurate diagnosis, more personalized treatments, and better outcomes for patients. With QuantX Advanced, we are now ‘all-in’ in the fight against breast cancer,” CEO Keith Tipton said in a prepared statement.

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Trumpcare goes down on no vote for ‘skinny repeal’

US Senate Republicans failed today to pass a ‘skinny’ bill which would have begun the process of dismantling Obamacare, leaving the future of the GOP-led effort to repeal and replace former President Barack Obama’s signature healthcare law in question.

Three Republican senators – John McCain (R-Ariz.), Susan Collins (R-Maine) and Lisa Murkowski (R-Alaska) – joined Senate Democrats in a dramatic 51-49 vote to reject the ‘skinny’ bill during the early morning.

“It’s time to move on,” Senate Majority Leader Mitch McConnell (R-Ky) said after the bill was defeated. “This is clearly a disappointing moment. The American people are going to regret that we couldn’t find a better way forward.”

The ‘skinny bill’ would have repealed only a few key parts of Obamacare and came after broader legislation was defeated earlier in the week.

The bill, released only 3 hours before voting began, would have retroactively repealed Obamacare’s individual mandate, alongside an 8-year repeal of penalties on certain businesses which did not provide employees with insurance, a repeal of the medical device tax until 2020 and the defunding of Planned Parenthood for at least 1 year.

In its report, the nonpartisan Congressional Budget Office estimated that the bill would have resulted in 15 million individuals losing insurance in 2018.

John McCain, who cast a surprising ‘no’ vote which killed the last-resort repeal bill, said he did so because he didn’t think the bill would “actually reform our healthcare system” and improve coverage, according to The Hill.

“While the amendment would have repealed some of Obamacare’s most burdensome regulations, it offered no replacement to actually reform our healthcare system and deliver affordable, quality healthcare to our citizens,” McCain said, according to the report.

McCain returned to Washington DC this week after being diagnosed with brain cancer, and was a deciding vote in opening the bill to debate on the Senate floor.

In his speech after the vote, McCain urged a bipartisan approach, stating that “one of the major failures of Obamacare was that it was rammed through Congress by Democrats on a strict-party line basis without a single Republican vote.”

The failure leaves Trump without a major legislative win after more than 6 months in power, despite Republican control of the White House, Senate and House of Representatives.

“3 Republicans and 48 Democrats let the American people down. As I said from the beginning, let Obamacare implode, then deal. Watch!” Trump wrote in Twitter in his response to the failed bill.

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AtriCure gains on Q2 revenue beat, raised outlook

AtriCure (NSDQ:ATRC) shares gained today after the medical device company yesterday reported higher-than-expected sales and raised its outlook for the rest of the year.

The Mason, Ohio-based cardiovascular device company posted losses of -$6.9 million, or -21¢ per share, on sales of $45.2 million for the three months ended June 30, paring its losses by -16.1% on sales growth of 14.0% compared with Q2 2016.

Analysts on Wall Street were looking for losses per share of -21¢ on sales of $43.3 million.

“We are executing on our strategy to deliver solid, balanced, results across our business while progressing forward our clinical trials and strategic initiatives,” president & CEO Mike Carrel said in prepared remarks. “We are also continuing to strengthen our leadership team and look forward to sustained momentum across our business throughout 2017.”

AtriCure said it still expects to post losses of -94¢ to $1.04 per share this year, but raised the low end of its 2017 sales guidance to $177 million to $178 million, compared with $175 million to $178 million previously.

ATRC shares were up 6.4% to $24.14 in mid-morning trading today.

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Titan Medical closes $7m offering

Titan Medical (TSX:TMD) said today that it closed a stock offering worth about $7 million for the Sport robot-assisted surgery platform it’s developing.

The round consisted of two tranches, according to Toronto-based Titan: an initial round worth $5.7 million (C$7.3 million) and a subsequent $1.3 million (C$1.7 million)  tranche, for gross proceeds of roughly $7.1 million (C$8.9 million).

Funds from the offering will be used to continue support of its Sport robotic surgical system, according to a company press release, as well as to support working capital and other general corporate purposes.

Earlier this month, Titan Medical said it inked a collaborative deal with Florida Hospital Nicholson Center to engage in a feasibility and validation study of Titan’s Sport robotic surgical system as the company seeks regulatory approval for the platform.

($1 = C$1.24582)

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Tandem shares slide after Q2 sales miss

Shares in Tandem Diabetes Care (NSDQ:TNDM) fell yesterday after the medical device maker missed sales expectations but beat EPS estimates on Wall Street with its second quarter results.

The San Diego, Calif.-based company posted a loss of -$21.8 million, or -44¢ per share, on sales of $21.3 million for the 3 months ended June 30, for bottom-line loss of -19% on sales loss of -7% compared with the same period last year.

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

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Prolonging the lives & independence of Alzheimer’s patients with artificial intelligence

With modern medicine and public health measures extending the average person’s life expectancy, a growing population is coming face to face with the challenges of age – including cognitive decline.

Addressing the needs of people dealing with cognitive change is no simple task. And today’s healthcare workers are hungry for objective, meaningful data to help determine how to best treat their patients.

Ruth Poliakine is hoping that her 5-person analytics company, MyndYou, can help harvest that purposeful data.

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

The post Prolonging the lives & independence of Alzheimer’s patients with artificial intelligence appeared first on MassDevice.

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