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 ...
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 ...
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While recent draft guidance from the Food and Drug Administration pertaining to artificial intelligence-enable medical ...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 ...
BioWorld8d
FDA hits Q’Apel Medical with warning for design changes to Hippo
The U.S. FDA warning letter to Q’Apel Medical Inc., of Fremont, Calif., lists several deviations from the regulation, but the ...
FDA classifies recall of Medtronic embolization devices as 'most serious'
The U.S. Food and Drug Administration on Tuesday classified the recall of Medtronic's embolization device as "most serious", ...
Medical Design & Outsourcing9d
De-risking medical device startups with a systematic approach to innovation
XBeta founder Frederick Kruger offers advice for medical device startups based on his firm's development of the Spiro Wave ...
Business Wire14d
Paragonix Secures EU MDR Approval for Five Organ Preservation Devices
Paragonix organ preservation devices are FDA cleared and have been used in ... reinforcing our commitment to delivering innovative and regulatory-compliant medical devices,” said Dr. Lisa ...
Yahoo Finance14d
Nearly a third of FDA medical device adverse event reports filed late
Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug Administration ... concerns or pursue other regulatory actions.