News

FDA flags problems with two Boston Scientific heart devices tied to injuries and deaths
U.S. health regulators are warning doctors and patients about safety issues with two separate Boston Scientific heart devices ...
Wicked Local9h
Warning issued by FDA for 2 heart devices made by Boston Scientific. What to know
While neither warning is classified as a recall, the FDA has provided additional information for the two products. Boston Scientific told customers that its Endotak Reliance defibrillation leads with ...
Medical Design & Outsourcing3h
FDA issues its position on PFAS in medical devices
The FDA recently said there is no reason to restrict the use of certain PFAS in medical devices, citing decades of safe use and no evidence linking the materials to patient harm.
National Law Review1d
FDA’s Position on Medical Devices and PFAS
For now, FDA has determined that it will not seek to impose a blanket PFAS restriction for medical device applications, as ...
Boston Scientific updates instructions of devices linked to 17 deaths
Boston Scientific has updated the instructions for use for products deployed in the implantation of its Watchman heart device ...
MassDevice6h
FDA issues alert for updated instructions for certain Boston Scientific Watchman access systems
The FDA has issued an early communication to warn of updated instructions for use for certain Boston Scientific Watchman access systems.
FDA Warns About Safety Issues With Boston Scientific Heart Devices
The FDA said some of Boston Scientific ’s Endotak Reliance defibrillator wires can become calcified, which may stop the ...
TCTMD2d
FDA Warns of Air Embolism Risk With Watchman LAAO Access Systems
Boston Scientific is recommending updates to the instructions for use to minimize the issue, which has been tied to 17 deaths ...
GlobalData on MSN7d
FDA approves SetPoint’s neuroimmune modulation device for RA treatment
The agency’s decision was based on the outcomes of the double-blind, randomised, sham-controlled RESET-RA study.
Yahoo5mon
FDA moves to rehire medical device, food safety and other staffers ...
The FDA hasn’t released official numbers on the terminations, but former FDA officials have pegged the number at roughly 700, with more than 220 coming from the medical device center.
100 days into the job, FDA head talks to CNN about agency goals— and Coke’s switch to sugar
Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...
The Globe and Mail2y
FDA Medical Device Regulation Guide 2022: How the Courts and the FDA ...
The "FDA Medical Device Regulation" directory has been added to ResearchAndMarkets.com's offering. The Guide to Medical Device Regulation contains the highest quality analyses on the regulation of ...