Exclusive: FDA staff struggle to meet product review deadlines after DOGE layoffs
Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...
Fierce Biotech7h
FDA’s novel medical device clearances slow to a crawl
According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...
Medical Device Network on MSN10h
MedCAD secures FDA 510(k) clearance for AccuStride foot and ankle system
The AccuStride System is intended to enhance surgical outcomes for proximal phalanx and metatarsal arthroplasty.
Targeting FDA user fees would leave agency gutted, experts say
Critics worry that the user fee program creates a conflict of interest between the FDA and pharmaceutical companies.
Med Device Online1d
Navigating The 2025 Medtech Regulatory Landscape In Switzerland And The U.K.
Switzerland is working toward reestablishing its relationship with the EU while exploring new avenues. Meanwhile, the U.K. is ...
US FDA approves first treatment for rare genetic disorder Prader-Willi syndrome
The U.S. Food and Drug Administration on Wednesday approved Soleno Therapeutics' drug to treat a rare genetic disorder, ...
GovInfoSecurity1d
Reading the Tea Leaves in FDA's AI-Enabled Device Guidelines
While recent draft guidance from the Food and Drug Administration pertaining to artificial intelligence-enable medical ...
Powerful Medical Receives FDA Breakthrough Device Designation for PMcardio STEMI AI ECG Model
Press Release Powerful Medical, a leader in AI-driven cardiovascular diagnostics, announces that its PMcardio STEMI AI ECG model has been granted Breakthrough Device Designation by the US Food and ...
JD Supra1d
Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical ...