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 ...
Modern Healthcare15d
Medical device recalls hit a four-year high in 2024. Here’s why
Medical device recall events in 2024 reached their highest level ... It’s largely because the agency is working to improve ...
MedPage Today on MSN2d
FDA's Deadline Ignored in Nearly 30% of Device Safety Reports
The FDA has allowed a substantial amount of late reports and undated reports into its Manufacturer and User Facility Device ...
JD Supra3d
Prescription Medical Device Manufacturers, Distributors, and the NABP: The Role in State Licensing
The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers ...
MedTech Dive3d
New FDA pulse oximetry guidelines could stall under Trump
The draft guidance addresses concerns that pulse oximeters are less accurate for people with dark skin tones. Experts raised ...
More than 1.2 million medical device side-effect reports not submitted within legal timeframe, analysis finds
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
Modern Healthcare8d
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 ...
Medical Design & Outsourcing9d
Regulatory consultant offers help for FDA’s tougher pulse oximeter draft guidance
MethodSense says it is helping pulse oximeter manufacturers with FDA draft guidance to enhance accuracy across diverse skin ...
Makary tells Senate panel he plans to review FDA job cuts
FDA nominee Marty Makary asked about abortion drugs, vaccine panels during a Senate hearing to advance his bid to lead agency ...
GlobalData on MSN7d
FDA clears Qiagen’s QIAstat-Dx Gastrointestinal Panel 2 Mini B
The FDA has granted clearance to Qiagen’s QIAstat-Dx Gastrointestinal Panel 2 Mini B, expanding the company’s syndromic ...
EurekAlert!2d
Over 1.2 million medical device side-effect reports not submitted within legal timeframe
Over 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data ...