Hemodialysis device maker Phraxis raises $6m
Early stage medical device company Phraxis has raised approximately $5.6 million in a new round of equity and options financing, according to a recently posted SEC filing. Phraxis is developing a novel treatment for patients who need vascular access for hemodialysis, according to the company’s website. The St. Paul, Minn.-based company’s first product for commercialization is the InterGraft, a percutaneously delivered arteriovenous shunt intended to provide a unique, non-surgical approach for patients who need vascular access, according to the site. Money in the round came from seven unnamed investors, with the...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Phraxis Inc. Source Type: news

Homeland Security details vulnerabilities in Medtronic ICD, CRT-Ds, CareLink devices
The U.S. Dept. of Homeland Security today released a medical advisory warning of exploits within a number of Medtronic (NYSE:MDT) implanted cardiac devices and associated equipment that could allow an attacker to affect the functionality of the devices or intercept transmitted sensitive data. The vulnerability affects Fridley, Minn.-based Medtronic devices using its Conexus radio frequency telemetry protocol, according to the release, and requires only a low level of skill and adjacent access to exploit. Successful exploitation could allow an outside actor to “interfere with, generate, modify, or intercept” the...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Software / IT Medtronic Source Type: news

IceCure Medical touts interventional radiology cryoablation study data
IceCure Medical yesterday released data from an interventional radiology study of its liquid-nitrogen-based cryoablation technology. Results from the study were presented at the Annual European Association of Urology Congress in Barcelona, the Israel-based company said. IceCure Medical’s ProSense cryoablation system uses liquid nitrogen technology for the treatment of benign and cancerous tumors through freezing, the company said. “The ProSense system has already demonstrated excellent progress as a rapid, in-office solution for the treatment of breast tumors. This new data adds to our growing clinical evi...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials IceCure Medical Ltd. Source Type: news

FDA approves Otimizer Smart heart failure device from Impulse Dynamics
The FDA today said it approved the Optimizer Smart heart failure device developed by Impulse Dynamics under its breakthrough device designation. The Stuttgart, Germany-based company’s device is designed to remodel the myocardium to increase the heart’s efficiency using “cardiac contractility modulation” – non-excitatory electrical pulses delivered to the heart muscle. An FDA advisory panel last December recommended approval for Optimizer Smart, voting voted 12-1 on safety, 11-2 on efficacy and 12-0, with a single abstention, that its benefits outweigh the risks. The system has had CE Mark appr...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Food & Drug Administration (FDA) Regulatory/Compliance Impulse Dynamics Source Type: news

Semtech, Sonova ink hearing aid development deal
Sonova Holding AG (SIX:SOON) and semiconductor maker Semtech said today they jointly developed a new advanced radio system intended for use in Sonova’s hearing aids. The new technology, an ultra-small integrated circuit, will serve as the main component in a new generation of hearing aids and enable support for multiple radio protocols in the 2.4GHz band, the companies said. “This chip allows Sonova to move in a new direction with our hearing aids. The breakthrough radio technology and power management are the game changers for hearing aids. It allows them to support a number of applications that have prev...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Otolaryngology Ear, Nose & Throat Research & Development Sonova Holding AG Source Type: news

Appeals court declines full review of $254m Zimmer loss to Stryker
A federal appeals court declined a full review of its earlier decision to affirm a $248 million win for Stryker (NYSE:SYK) in its surgical tool patent case against Zimmer Biomet (NYSE:ZBH). The U.S. Court of Appeals for the Federal Circuit last December upheld treble damages in the case, based on a U.S. Supreme Court decision in Halo Electronics v. Pulse Electronics that relaxed the standard for enhanced damage awards in patent infringement cases. Zimmer Biomet appealed that per curiam decision, asking for both a three-judge panel and the full Federal Circuit bench to re-evaluate the case. The court denied both petiti...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Legal News Orthopedics Wall Street Beat Stryker Zimmer Biomet Source Type: news

Teleflex touts real-world UroLift study data
Teleflex (NYSE:TFX) today released results from real-world studies of its UroLift minimally invasive treatment for benign prostatic hyperplasia, touting its safety and effectiveness. Data from the studies were presented at the 2019 European Association of Urology meeting in Barcelona, Spain. The UroLift system uses tiny devices inserted into the urethra in a minimally invasive procedure to reopen the lower urinary tract by pushing aside tissue from the enlarged prostate, the Wayne, Penn.-based company said. Teleflex said that it presented data from a real-world retrospective study of 30 men with urinary rete...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Urology Teleflex Source Type: news

NE Ohio biomedical industry investments on the rise
Investment in the northeast Ohio biomedical sector totaled nearly $294 million in 2018 with 71 regional companies receiving funding, according to regional healthcare trade group BioEnterprise. Those figures make this region the third largest for total healthcare investment in the Midwest, following Minneapolis ($664 million) and Chicago ($551 million). These were among the findings of BioEnterprise’s 2018 Midwest Healthcare Growth Capital Report, which tracks capital investments made in biomedical companies across 11 Midwestern states in three sectors — medical device; biotechnology and pharmaceuticals; and hea...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Biotech Blog Business/Financial News Funding Roundup News Well Athersys Inc. BioEnterprise ViewRay Inc. Source Type: news

Appeals court reverses Organogenesis win in gender bias, retaliation lawsuit
A U.S. federal appeals court this week reversed a win for Organogenesis in an employment discrimination and retaliation lawsuit from former employees, according to recently released court documents. The U.S Court of Appeals for the Ninth Circuit reversed and remanded the case filed by former employees Angela Gonzales, Linda Boyd and Brandee Colombo against Canton, Mass.-based Organogenesis. In the case, which had previously been granted a summary judgement in Organogenesis’ favor, the employees levied one claim of retaliation and three claims of gender discrimination. The appeals court said it believed that the distr...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Legal News Organogenesis Inc. Source Type: news

Abiomed ’ s stake in Shockwave is worth at least $58m
The $10 million Abiomed (NSDQ:ABMD) put into Shockwave Medical (NSDQ:SWAV) has paid off so far no matter how you slice it. Shockwave raised nearly $97 million in an initial public offering earlier this month, inking a private-placement deal with Abiomed on the side for $10.0 million worth of SWAV shares at the $17-per-share IPO price. In a regulatory filing today, Santa Clara, Calif.-based Shockwave said Abiomed owns nearly 1.7 million shares, or a 6.0% stake. With SWAV shares trading at $34.55 apiece today in mid-morning activity (up 4.8%), Danvers, Mass.-based Abiomed’s share would be worth roughly $58.7 million if...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Wall Street Beat Abiomed Shockwave Medical Source Type: news

Neovasc claims win in German TMVR patent case against Edwards unit CardiAQ Valve
Neovasc (NSDQ:NVCN) today claimed a win in its patent infringement war with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve Technologies, saying a German appeals court dismissed a case there. In June 2017 the District Court in Munich ruled that CardiAQ Valve contributed to the creation of Neovasc’s Tiara transcatheter mitral valve replacement, awarding”co-entitlement” rights to the patent in Europe. Both sides appealed that ruling, in the course of which CardiAQ withdrew its total ownership claim but asserted partial ownership, Vancouver-based Neovasc said today. Munich’s Higher Re...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Legal News Replacement Heart Valves Wall Street Beat CardiAQ Valve Technologies Edwards Lifesciences neovasc Source Type: news

Novo Nordisk seeks FDA nod for oral diabetes pill
Novo Nordisk (NYSE:NVO) said this week that it submitted applications to the FDA for its oral formulation of semaglutide, a once-daily glucagon-like peptide-1 receptor agonist therapy. The company is hoping its pill will be approved as an adjunct to diet and exercise to improve blood sugar control in adults with Type 2 diabetes. Novo Nordisk also submitted for approval of an indication related to risk reduction of major adverse cardiovascular events. Get the full story at our sister site, Drug Delivery Business News. The post Novo Nordisk seeks FDA nod for oral diabetes pill appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Diabetes Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Novo Nordisk Source Type: news

Taking a more rigorous approach to investigating fatal medical errors in the U.S.
By Stewart Eisenhart, Emergo Group On Friday, March 1, 2019, a Tesla automobile was involved in a fatal crash in Palm Beach, Florida. Considering the possibility that the vehicle crash occurred while the vehicle was in autopilot mode, the National Highway Traffic Safety Administration (NHTSA) and the National Transportation Safety Board (NTSB) initiated an investigation of the accident. 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. The post Taking a more rigorous approach...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

Establishment Labs shares up on mixed-bag Q4, FY2018 earnings
Shares in breast implant maker Establishment Labs rose in after-hours trading today after the company posted fourth quarter and full year 2018 earnings that beat sales expectations but missed loss-per-share consensus on Wall Street. The New York-based company posted losses of $10.5 million, or 52¢ per share, on sales of approximately $16.4 million for the three months ended December 31, seeing sales grow 38.8% while losses grew 47.4% compared with the same period during the previous year. Losses per share were ahead of the 36¢ loss-per-share consensus on Wall Street where analysts expected to see sales of ap...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat Establishment Labs Source Type: news

Carbon debuts dental technology platform
Carbon’s L1 3D printer (Image from Carbon) 3D printing company Carbon unveiled an integrated technology platform for the dental market this week at the International Dental Show in Cologne, Germany. The platform combines software, hardware and materials in an end-to-end solution designed to meet the needs of dental and orthodontic labs and enable them to scale quickly and economically, according to the Redwood City, Calif. company. Carbon also debuted its new M2d printer for mid-sized dental and orthodontic labs with lower volume needs, as well as its L1 Production Solution for high-volume production of clear al...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Dental Featured News Well Carbon Dentsply Sirona dreve internationaldentalshow keystoneindustries Source Type: news

PolarityTE reveals SEC investigation
PolarityTE (NSDQ:PTE) this week revealed that it is the target of an SEC investigation into possible violations of federal securities laws. The Salt Lake City, Utah-based company said that it received a copy of a formal order of investigation from the SEC on March 4, exploring possible violations of fraud and price manipulations, according to an SEC filing. Read the whole story on our sister site, Drug Delivery Business News The post PolarityTE reveals SEC investigation appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Legal News Regenerative Medicine polarityte Source Type: news

Nyxoah sleep apnea neuro-stim therapy gains CE Mark
Nyxoah said it has won the CE Mark for its novel hypoglossal nerve stimulation therapy for treating obstructive sleep apnea (OSA). The Genio system is a battery-free, leadless and minimally invasive neurostimulator designed to deliver bilateral hypoglossal nerve stimulation for moderate to severe obstructive sleep apnea patients who have failed conventional continuous positive airway pressure (CPAP) therapy. Get the full story on our sister site, Medical Design & Outsourcing. The post Nyxoah sleep apnea neuro-stim therapy gains CE Mark appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Source Type: news

OptiScan raises $20m for bedside glucose monitoring system
OptiScan Biomedical said today that it closed a $20 million Series E round to support the commercialization of its continuous monitoring system, the OptiScanner 5000, in the U.S. The company’s device is an automated bedside blood glucose monitor designed for use in the intensive care unit. The system can measure glucose values from a micro-sample of blood without the need for calibration, according to OptiScan. Get the full story at our sister site, Drug Delivery Business News. The post OptiScan raises $20m for bedside glucose monitoring system appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Diabetes Featured Funding Roundup Hospital Care OptiScan Source Type: news

Ex-NuVasive CEO Lucier to head new M & A firm Corza Health
Ex-NuVasive CEO Gregory Lucier will lead new M&A-focused company Corza Health. Recently departed NuVasive (NSDQ:NUVA) CEO Gregory Lucier will lead a new company formed to acquire medtech and life sciences firms and assets. Lucier, 54, is partnering with Chicago-based private equity firm GTCR to form the new company, Corza Health, in San Diego. GTCR holds stakes in Regatta Medical, which owns laser micro manufacturer Resonetics and Sotera Health along with life sciences, technology, and financial and business services companies. Get the full story on our sister site, Medical Desig...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Featured Mergers & Acquisitions News Well Orthopedics Robotics bestbuy corzahealth greatcall gtcr Life Technologies Corp. Nuvasive Thermo Fisher Scientific Source Type: news

Ex-NuVasive CEO Lucier to head new M & A firm
Ex-NuVasive CEO Gregory Lucier will lead new M&A-focused company Corza Health. Recently departed NuVasive (NSDQ:NUVA) CEO Gregory Lucier will lead a new company formed to acquire medtech and life sciences firms and assets. Lucier, 54, is partnering with Chicago-based private equity firm GTCR to form the new company, Corza Health, in San Diego. GTCR holds stakes in Regatta Medical, which owns laser micro manufacturer Resonetics and Sotera Health along with life sciences, technology, and financial and business services companies. Get the full story on our sister site, Medical Desig...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Featured Mergers & Acquisitions News Well Orthopedics Robotics bestbuy corzahealth greatcall gtcr Life Technologies Corp. Nuvasive Thermo Fisher Scientific Source Type: news

Boston VC shop Flagship Pioneering raises $824m with 8th fund
Life-sciences focused venture capital group Flagship Pioneering said today that it raised $824 million for its new Special Opportunities Fund II, which aims to support companies created by its Flagship Labs unit. The funds join an existing capital pool of more than $700 million Flagship said it raised between late 2017 and 2018 to finance its in-house plays. Investors in the new Special Opportunities Fund II include long-time limited partners, new institutional investors and family offices and follows the $285 million Special Opportunities Fund I which closed in 2016. Flagship said that it has launched more than 75 venture...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Source Type: news

Syneron Candela, InMode settle patent suits
Syneron Candela (NSDQ:ELOS) said today it inked a settlement deal with InMode Aesthetic Solutions to end a patent dispute between the companies. Through the settlement deal, Wayland, Mass.-based Syneron Candela said that it offered InMode a sublicense to continue to market its bi-polar fractional radiofrequency product line. The companies did not release terms of the settlement deal. Each party in the suit will cover their own costs, attorney’s fees and expenses, according to court documents from the U.S. District Court for the District of Massachusetts, while the charges were dismissed with prejudice. “Ca...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Fink Densford Tags: Legal News Patent Infringement Syneron Medical Ltd. Source Type: news

Siemens wins FDA nod for Mobilett Elara Max mobile X-ray
Siemens (NYSE:SI) Healthineers said today that it won FDA 510(k) clearance for its Mobilett Elara Max mobile X-ray system. The Erlangen, Germany-based company touted that the newly cleared system features improved IT security and secure system integration to allow access of patient data at any time. Siemens Healthineers also said that the system features antibacterial coating and an improved ergonomic design for better maneuverability. “Siemens Healthineers is pleased to offer the Mobilett Elara Max, a mobile X-ray system with advanced cybersecurity features that provide state-of-the-art patient data protec...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Imaging Regulatory/Compliance Siemens Healthineers Source Type: news

Brainlab acquires Medineering ’ s robotics platform
Brainlab said today that it acquired Medineering and its line of robot-assisted surgery devices for an undisclosed amount. Brainlab, which earlier this month dealt its orthopedic joint reconstruction assets to Smith & Nephew (NYSE:SNN), is already an investor and markets the Medineering robot-assisted surgical arm under the Cirq brand. The Munich-based company said it plans to fold the Medineering tech into its open-architecture surgery offering. “Medineering introduced a fresh new approach to surgical robotics when we entered into our partnership less than three years ago,” pesident & CEO Stefan Vilsme...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Mergers & Acquisitions Robotics Wall Street Beat Brainlab Medineering Source Type: news

FDA warns Integra ’ s TEI Biosciences over quality, validation issues
The FDA recently revealed a warning letter it sent to Integra LifeSciences‘ (NSDQ:IART) TEI Biosciences over four noted violations it found during an inspection of TEI’s Boston-based facilities. The federal watchdog said that it inspected the company’s facilities where it produces collagen-based medical devices, including its Xenform soft tissue repair matrix, from last October to November last year. The recently released letter covers both the noted violations and a number of responses from the company it received from last November to February. The FDA’s first noted violation was a failure properl...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Integra LifeSciences TEI Biosciences Source Type: news

Nevro taps ex-Thoratec CEO Grossman | Personnel Moves, March 20, 2019
Nevro Corp. (NYSE:NVRO) said yesterday that it named former Thoratec CEO Keith Grossman to replace president & CEO Rami Elghandour after striking a deal with one of its investors, Broadfin Capital. Grossman re-joined Thoratec after taking over at Conceptus in December 2011 and leading it to a $1.1 billion sale to Bayer in June 2013 (he’d been Thoratec’s CEO from 1996-2006). Grossman helmed Thoratec until St. Jude Medical (now Abbott) acquired it in October 2015 for $3.3 billion. Nevro said the deal with Broadfin also involves the expansion of its board of directors with the addition of Warburg Pincus l...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Business/Financial News AdvaMed California Life Sciences Assn CardioMech Check-Cap electroCore LivaNova Nevro Corp. Personnel Moves renovia Synaptive Medical Tactile Systems Technology Source Type: news

Sage wins historic FDA nod for postpartum depression therapy
Sage Therapeutics (NSDQ:SAGE) this week won FDA approval for the first medicine indicated to treat postpartum depression. The Cambridge, Mass.-based company’s injection therapy, Zulresso, is slated to be available in late June. Postpartum depression is the most common medical complication of childbirth, according to Sage, and affects roughly one in nine women who have given birth in the U.S. Get the full story at our sister site, Drug Delivery Business News. The post Sage wins historic FDA nod for postpartum depression therapy appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Drug-Device Combinations Featured Food & Drug Administration (FDA) Neurological Pharmaceuticals Wall Street Beat sagetherapeutics Source Type: news

FDA warns J & J, Sientra over lack of post-approval silicone gel breast implant studies
The FDA today released warning letters it sent to Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide and Sientra (NSDQ:SIEN) over failures to conduct appropriate post-approval studies to analyze the long-term safety and risks associated with their silicone gel-filled breast implants. The federal watchdog said that every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies of the devices to maintain appropriate data on the long-term safety and potential risks associated with the devices that premarket trials cannot foresee. In its letter to J&J&rsq...
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Featured Food & Drug Administration (FDA) Women's Health johnsonandjohnson Mentor Worldwide Sientra Source Type: news

Baxter, Biom érieux ink acute kidney injury biomarker dev deal
Baxter (NYSE:BAX) said today that it inked a partnership deal with Biomérieux looking to develop biomarkers to identify acute kidney injury. The partnership was announced at the International Symposium on Intensive Care and Emergency Medicine, Deerfield, Ill.-based Baxter said. Both companies said they hope to develop the biomarkers to help rapidly identify and inform treatment of acute kidney injuries, which can lead to death if untreated. “We’re committed to improving outcomes for critically ill patients across the continuum of care, which includes identifying opportunities to diagnose AKI ea...
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Diagnostics Research & Development Baxter BioMerieux Inc. Source Type: news

Report: French commission calls for massive medtech regulation overhaul
A French parliamentary body is calling for a significant overhaul of medical device regulations in the country and across Europe, calling the existing system “massively dysfunctional,” according to a new report from the International Consortium of Investigative Journalists’ Implant Files. A French Specially Convened Commission on Medical Devices, composed of parliamentarians Julein Borowczyk and Pierre Dharréville, recently endorsed a 97-page report advocating for 36 separate reforms, according to the report. Endorsed reforms include the creation of a centralized European agency in control of appro...
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Regulatory/Compliance European Medicines Agency (EMA) Source Type: news

Theranica raises $35m Series B for neuromod migraine patch
Theranica Bio-Electronics said yesterday that it raised a $35 million Series B round for the Nerivio Migra neurostim patch it’s developing to treat migraine headache. Netanya, Israel-based Theranica said VC shop aMoon led the round, joined by all of its existing backers, Lightspeed Venture Partners, LionBird, Corundum Open Innovation and Takoa. The company raised an unspecified amount in its seed round back in September 2016. Theranica closed out a nearly 300-patient pivotal study last October it used to back a bid for FDA clearance that met its primary endpoint and showed “high efficacy, safety and tolerabilit...
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Neuromodulation/Neurostimulation Pain Management Wall Street Beat Theranica Bio-Electronics Source Type: news

Boston Scientific touts Luminize catheter study
Boston Scientific (NYSE:BSX) this week touted results from a study of a single-shot ablation catheter for atrial fibrillation at a European cardiac rhythm conference. The Marlborough, Mass.-based medical device giant said the 100-patient AF-ficient I study of intermittent AF proceeded in two stages. Phase one, testing the original Luminize design, showed a pulmonary vein isolation rate of 88.9%; phase two, testing enhanced steering and electrodes, showed a PV isolation rate of 99.4%. The median balloon dwell time dropped from 92 minutes in the first phase to 29 minutes in the second, bringing total procedure time down...
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Clinical Trials Featured Boston Scientific Cardiac Rhythm Management Source Type: news

ACC 2019 Roundup – ReCor touts six-month Paradise renal denervation study results
This study effectively shows that by giving health consumers the tools they need to better manage their health, we can empower them to live healthier lives,” senior study author and chief medical officer Dr. Bimal Shah said in a prepared statement. Read more  Neovasc presents Reducer data Neovasc (NSDQ:NVCN) said today that it released data on its Neovasc Reducer device during the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans. During the session, researchers explored the treatment of refractory angina in patients with no options, Vancouver-based Neovasc said, tou...
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Featured Patient Monitoring ReCor Medical Source Type: news

Theranos whistleblower Tyler Shultz to participate in keynote interview at DeviceTalks Boston
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. DeviceTalks is excited to announce that Tyler Shultz will be the closing keynote speaker at DeviceTalks Boston. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos. Once the darling of Silicon Valley, Theranos collapsed after Shultz went public with his concerns about the company. “We are so excited that Tyler is joining DeviceTalks Boston as our closi...
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Featured DeviceTalks Boston Theranos Source Type: news

Medical device cybersecurity: It ’s time to get real
Medical device makers, regulators and healthcare delivery organizations are increasingly working together to strengthen cybersecurity. But are they doing enough? [Original image courtesy of istockphoto.com]Almost no one in the medtech industry disputes the vulnerability posed by cyberattacks. How to go about boosting security is another matter – one on which those stakeholders have recently stepped up their collaboration. One group, the Healthcare & Public Sector Coordinating Council, thinks it has a solution: Health providers and other customers buying a connected medical device should be able to remotely access...
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Business/Financial News Featured Health Information Technology Software / IT Abbott bectondickinson Cybersecurity Green Hills Software Mayo Clinic Source Type: news

Study shows catheter ablation for Afib significantly boosts quality of life
Patients who had catheter ablation for atrial fibrillation (Afib) had fewer symptoms, a significant long-term improvement in quality of life and fewer recurrences and hospitalizations than those who received drug therapy alone, according to a government-funded study. The same study showed that catheter ablation appeared no more effective than drugs in preventing strokes, deaths, and other complications. Get the full story on our sister site, Medical Design & Outsourcing. The post Study shows catheter ablation for Afib significantly boosts quality of life appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Catheters Clinical Trials News Well Mayo Clinic National Institutes of Health (NIH) Source Type: news

Surmodics shares down following FDA ’s paclitaxel device update
Surmodics (NSDQ:SRDX) shares fell last week after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices. In an SEC filing, the company said that it’s working with the FDA to clarify how the company should proceed with an ongoing clinical trial of its paclitaxel-coated SurVeil balloon. Get the full story at our sister site, Drug Delivery Business News. The post Surmodics shares down following FDA’s paclitaxel device update appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Featured Food & Drug Administration (FDA) Pharmaceuticals Vascular Wall Street Beat SurModics Inc. Source Type: news

Zoll reveals data breach during email server migration
Zoll Medical said today that it experienced a data breach during an email server migration that exposed select confidential patient data. The data exposed included patient names, addresses, dates of birth, limited medical information and some social security numbers, the Chelmsford, Mass.-based company said. Zoll said that its email is archived by a third-party service provider and that during a server migration, some data from Zoll emails were exposed. The incident is believed to have occurred between November 8, 2018 and December 28, 2018. The company said that it has now secured all information and that it is not aware ...
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Zoll Medical Corp. Source Type: news

EOFlow wins breakthrough status for wearable closed-loop insulin delivery tech
Korean medtech company EOFlow said last week that it won breakthrough status from the FDA for its closed-loop automated insulin delivery system for people with Type 1 diabetes. The EOPancreas system features a wearable patch, continuous glucose monitoring systems and a closed-loop blood glucose control algorithm. Get the full story at our sister site, Drug Delivery Business News. The post EOFlow wins breakthrough status for wearable closed-loop insulin delivery tech appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Featured Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance eoflow Source Type: news

3M rejiggers, names healthcare EVP
3M Cos. (NYSE:MMM) said yesterday that it’s slimming its corporate profile by folding its safety and industrial segments together and announced a slew of changes to its executive roster. The Twin Cities conglomerate said it plans to start reporting the move from five to four divisions – healthcare, safety & industrial, transportation & electronics and consumer – with its second quarter results. “We are continuing to advance 3M into the future, and today’s actions will strengthen our ability to meet the fast-moving needs of our customers,” CEO Mike Roman said in prepared remarks. ...
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Business/Financial News Featured Wall Street Beat 3m Source Type: news

Aptar Pharma touts FDA approval of nasal spray device
Aptar Pharma said this week that its Bidose nasal spray device won FDA approval for use with a breakthrough depression therapy. The Crystal Lake, Ill.-based company’s Bidose tech enables two-shot nasal drug delivery. Aptar touted its manufacturing facility in Congers, NY, which supports the manufacture of nasal and injectable drug delivery systems. Get the full story at our sister site, Drug Delivery Business News. The post Aptar Pharma touts FDA approval of nasal spray device appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Neurological Pharmaceuticals aptarpharma Source Type: news

Report: Smiths Medical parent co to announce separation plans Friday
Smith Medical‘s parent company Smiths Group (LON:SMIN) is expected to disclose how it plans to separate its medical division from the rest of the organization on Friday, according to a report from the Minneapolis Star Tribune posted yesterday. The conglomerate has been seeking buyers for its medical division over the past few years, and has also mentioned the possibility of an initial public offering. Last September, Smiths Medical ended possible merger plans with ICU Medical (NSDQ:ICUI) in a deal reportedly worth approximately $4 billion. The companies had been in discussions since last May. Listed amongst...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Mergers & Acquisitions Wall Street Beat Smiths Group plc Smiths Medical Source Type: news

Novartis ’ Alcon picks up PowerVision for $285m
Novartis (NYSE:NVS) subsidiary Alcon said today that it acquired intraocular lens developer PowerVision for $285 million. PowerVision is developing fluid-based intraocular lens implants that use the eye’s natural accommodating response to transport fluid in the implanted lens, Fort Worth, Texas-based Alcon said. The fluid-based lens creates a continuously variable monofocal lens using the natural contractions of the eye’s muscles, Alcon said, allowing a patient to actively focus on objects in a style similar to a young eye’s crystalline lens. “We’re thrilled to officially join A...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Mergers & Acquisitions Optical/Ophthalmic Alcon Novartis PowerVision Inc. Source Type: news

Histogenics to lay off all but 1 employee in restructuring
Histogenics (NSDQ:HSGX) said last week that its board of directors approved a restructuring plan that would result in layoffs for all but one of the company’s employees. The layoffs include CEO Adam Gridley and COO Stephen Kennedy. Gridley and Kennedy plan to evaluate “strategic alternatives” for the company in consulting capacities alongside up to four other unnamed employees, the company said in an SEC filing. The company noted that it expects to record a one-time charge for severance and related expenses of roughly $2.2 million by the end of the first quarter of 2019. Earlier this year, Histogenic...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Featured Wall Street Beat Histogenics Source Type: news

ACC 2019 Roundup: Abiomed Impella RP post-market study shows benefit in select patient group
Abiomed (NSDQ:ABMD) today released 18-month post-approval study data from patients treated with its Impella RP, touting a benefit to survival for specifically selected “Recover Right” protocol patients. Results from the study were presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans, the Danvers, Mass.-based company said. The review follows a release posted by the FDA last month warning of a 17.4% survival rate with the Impella RP heart pump system, approximately 55% lower than the rate noted in the premarket study of the device. Abiomed said that it met wi...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Featured Patient Monitoring Replacement Heart Valves Abbott Abiomed Medtronic Source Type: news

Can a lifetime guarantee boost value-based care?
Cheryl Bednar, 54, of Laflin, Penn., suffered from chronic pain from hip deterioration until Geisinger Dr. James Murphy performed a hip replacement in February 2018 and offered the lifetime guarantee. (Image from Geisinger) Swiss orthopedics company Medacta International and Geisinger Health System have said they will pilot a lifetime guarantee program for knee replacement surgeries. The program will cover full costs for screened Geisinger Health Plan members who receive knee replacement surgery while also ensuring reimbursement for any associated future care the patients may incur throughout their life...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Business/Financial News Featured Implants News Well Orthopedics Centers for Medicare and Medicaid Services (CMS) Geisinger Health System Medacta Source Type: news

ACC 2019: Abbott touts reduced stroke, bleeding and pump-clotting in HeartMate 3 trial
Abbott (NYSE:ABT) yesterday presented data from a new trial of its HeartMate 3 left ventricular assist device, touting a reduced rate of strokes, pump-related blood clots and bleeding episodes at two years as compared with the previous generation HeartMate II. Data in the trial was presented at the American College of Cardiology’s 68th Annual Scientific Session 2019 in New Orleans and published simultaneously in the New England Journal of Medicine, the Chicago-area medical device company said. Abbott touted its HeartMate 3 as the first implantable mechanical pump using fully magnetic levitation technology, makin...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Abbott Source Type: news

ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology. Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine. Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at ...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic Source Type: news

GI Dynamics touts results of U.K. study
GI Dynamics (ASX:GID) said a retrospective study of its EndoBarrier device for patients with type 2 diabetes and obesity shows a significant reduction in HbA1c, weight, liver fat and cardiovascular disease (CVD) risks as well as a reduction in the need for insulin in some patients. The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract, according to the Lexington, Mass.-based company. Get the full story on our sister site, Medical Design & Outsourcing. The post GI Dynamics touts results of U.K. study appeared ...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Clinical Trials Diabetes Featured News Well Research & Development Surgical Source Type: news

FDA updates docs on review of paclitaxel devices for PAD
The FDA said last week that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices. In a letter to healthcare providers, the U.S. regulatory agency reported that there was a 50% increased risk of mortality in people treated with paclitaxel-coated devices versus those treated with control devices in the three trials with five-year follow-up data. Get the full story at our sister site, Drug Delivery Business News. ...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Drug-Device Combinations Featured Food & Drug Administration (FDA) Pharmaceuticals Source Type: news