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 […]
Featured
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 […]
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 […]
ACC 2019 Roundup – ReCor touts six-month Paradise renal denervation study results
ReCor Medical this week released “on-medication” results from the RADIANCE-HTN-SOLO clinical trial of its Paradise renal denervation system intended to treat uncontrolled hypertension, touting medication and blood pressure reductions at six months. Results from the trial was presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans and were simultaneously published […]
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 […]
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? 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 […]
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 […]
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 […]
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 […]
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 […]
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 […]