The FDA said today that it will hold a two-day public advisory committee meeting looking for comments and data on surgical staplers and hemostatic agents next month. During the meeting, set to take place on May 30 and 31, the FDA will seek recommendations on reclassifying surgical stapler devices intended for internal use from Class […]
BaroNova wins FDA nod for TransPyloric Shuttle weight loss device
BaroNova said today that it won FDA approval for its TransPyloric Shuttle non-surgical device intended for treating obesity, now cleared as a weight loss solution for adults with obesity and a body mass index of 30 to 40 kg/m2. The San Carlos, Calif.-based company said that the device is approved for up to 12 months […]
FDA Form 483s could get easier for medical device companies: Here’s how
FDA in the U.S. is setting up a formal way for medical device companies to get nonbinding feedback about Form 483s, which raise potential manufacturing process problems. FDA is taking comments through today about the draft guidance, which it issued Feb. 19 under a requirement in the FDA Reauthorization Act of 2017. The proposed process […]
Nipro’s Infraredx wins expanded FDA nod for Makoto intravascular imager
Nipro (TYO: 8086) subsidiary Infraredx said today that it won expanded FDA 510(k) clearance for its Makoto intravascular imaging system, now cleared to identify patients and coronary plaques at an increased risk of major adverse cardiac events. The approval came based on results from the Lipid-Rich Plaque study in which researchers explored the ability of intravascular […]
NeuroSigma wins FDA nod for ADHD device
NeuroSigma won de novo clearance from the FDA last week to put the first medical device for treating attention-deficit hyperactivity disorder on the U.S. market. Los Angeles-based NeuroSigma makes the Monarch eTNS system, which is designed to deliver mild electrical signals through a forehead patch to stimulate branches of the trigeminal nerve during sleep. The device won […]
The grim stories behind seven of medtech’s worst failures
Medical devices save or restore thousands of patient lives every year, but the dark side to medtech innovation is increasingly drawing attention. For all the good the industry does, it’s worth remembering that the costs can be high – even fatal – when medical device companies don’t get things right. The examples range from women […]
FDA clears Tela Bio’s Restella soft tissue bioscaffolds
Tela Bio said yesterday that it won FDA 510(k) clearance for its Restella reconstructive bioscaffolds, now cleared for use in reinforcing soft tissue in patients requiring soft tissue repair or reinforcement during plastic or reconstructive procedures. The Malvern, Penn.-based company’s tech platform is based on interwoven polymer through layers of biologic tissue in a patented pattern […]
MedTech Europe warns of device flight to U.S. and China if MDR not ready
Europe’s medical device trade group is again warning the European Commission that its new Medical Device Regulation (MDR) system will not be ready by its 2020 deadline and that E.U. medtech companies are taking their business elsewhere as a result. In an open letter to Jyrki Katainen, the commission’s vice president for jobs, growth, investment and competitiveness, […]
Penumbra VR device wins FDA clearance
Penumbra recently announced that it has received FDA 510(k) clearance for its Real Immersive virtual reality system. The Real Immersive System is an immersive virtual reality and display system that tracks upper extremity rehabilitation exercises for adults who have symptoms related to acute pain, cerebral palsy, stroke, orthopedic or neurodegenerative diseases. The exercise routines with the […]
FDA approves Intact Vascular’s Tack dissection repair device
The FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular. The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient […]
FDA clears Gelesis weight-loss hydrogel pill Plenity
Gelesis (Boston) recently announced that it has received FDA clearance for its Plenity weight management prescription drug. The drug is a weight management aid for adults who have a body mass index of 25-40 kg/m2 and is supposed to be used with diet and exercise. It can be used in people with and without […]
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