Becker's ASC

Medical Device Industry Generally Positive About FDA’s Proposed Changes to Medical Device Approval Process

The medical device industry has generally expressed satisfaction with the Food & Drug Administration’s move to revise the 510(k) device approval process, according to a Mass Device news report. • ...
Medical Device Network on MSN

JenaValve strikes US market first with approval in TAVR-AR indication

The FDA PMA for JenaValve's Trilogy device for TAVR-AR comes months after a court struck down Edwards Lifesciences attempt to ...

What Medical Device Companies Need to Know About DOJ Enforcement

Opinion: Medical device companies can create a competitive advantage by leveraging data to strengthen compliance programs and by ensuring effective oversight of quality and regulatory reporting ...
D Magazine

Perimeter Medical Receives FDA Approval for AI Imaging Device for Breast Cancer Surgery

Dallas-based Perimeter Medical Imaging AI earned premarket FDA approval for Claire—its AI-powered imaging device for breast cancer surgery. Claire is the first AI-enabled device cleared in the U.S. to ...
Medical Device Network on MSN

Medtronic’s OmniaSecure defib lead nets another FDA approval

OmniaSecure is now the first defibrillation lead approved for placement in the left bundle branch.
PBS

One medical device is raising questions about FDA’s approval process

Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products, ...
Becker's ASC

Is There a Middle Ground for Medical Device Approval?

Bloggers at the Millennium Research Group’s blog compared the FDA and the European CE mark and the effects on innovation in both markets. According to industry experts the MRG authors interviewed, the ...

Belfast medtech firm Neurovalens secure EU and UK approval for insomnia treatment device

Modius Sleep is currently available via prescription in the US for $2,265 (£1,690) ...
PBS

FDA-approved medical device raising safety concerns

Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products, ...