Examining The FDA's Recommendations For AI-Enabled Medical Devices
The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...
FDA moves to rehire medical device, food safety and other staffers fired days earlier
Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news ...
FDA rehires staff to its medical devices division after mass layoffs
The Trump administration is reinstating some employees in the Food and Drug Administration's medical devices division after ...
Medical Device Network3h
FDA issues early alert for Baxter’s Spectrum infusion pump
The US Food and Drug Administration (FDA) has issued an early alert over a ‘potentially high-risk’ issue with certain Baxter ...
Modern Healthcare19h
FDA labels Philips' recall of Tack Endovascular Systems a Class I
Complications with the implant used to treat blood vessel dissection after balloon angioplasty or stent placement can result ...
Modern Healthcare7d
Medical device recalls hit a four-year high in 2024. Here’s why
Medical device recalls surged last year, driven by stricter FDA oversight and a big jump in the most serious type of recalls.
The Manila Times15m
NEXTBIOMEDICAL Secures FDA Breakthrough Device Designation for Innovative Resorbable Microsphere 'Nexsphere-F™'
SEOUL, South Korea, March 6, 2025 /PRNewswire/ -- NEXTBIOMEDICAL CO., LTD, a leading developer of cutting-edge Devices, announced that its groundbreaking product 'Nexsphere-F™,' a resorbable ...
InnovationRx: Trump’s Tariffs Could Hit Medical Devices, While USAID Cuts Cost Lives
In this week’s InnovationRx newsletter, tariffs could hit medical devices, a gene therapy company that helps blind kids see ...
FDA says Philips to discontinue distribution of Tack Endovascular System
The U.S. Food & Drug Administration said that Philips has removed and discontinued distribution of Tack Endovascular System ...
CNET7d
I Tested Microcurrent Devices for 2 Months. This Is the One I Like Best Overall
In the market for a microcurrent device? After two months of testing popular brands like ZIIP, FOREO, NuFACE and Therabody, ...
ABC News10d
FDA moves to rehire medical device staffers fired only days earlier
Beginning Friday night, FDA employees overseeing medical devices and other key areas received calls and emails notifying them that their recent terminations had been “rescinded effective ...