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 approving high-...
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 to ...
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.
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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, touting its Red...
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 a c...
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. “O...
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 other p...
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 Alcon and its...
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, Histogenics re...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Featured Wall Street Beat Histogenics Source Type: news
