STAT1h
Texas judge strikes down FDA’s plan to regulate lab-developed tests
The FDA has long believed it has the power to regulate lab-developed tests, but it only put out the rules under former President Biden.
Fierce Biotech4d
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 ...
abc2725d
MedRhythms Announces FDA Class II Listing for Movive™ to Support Gait Rehabilitation and Motor Function for Parkinson's Disease
PORTLAND, Maine, March 6, 2025 /PRNewswire/ -- MedRhythms today announced that MR-005, the company's neurorehabilitation system to support gait rehabilitation and motor function in adults with ...
Modern Healthcare1mon
Medical device recalls hit a four-year high in 2024. Here’s why
Medical device recall events in 2024 reached their highest level since 2020 and more than 10% of them involved the most serious type of recall. There were 1,048 medical device recalls in 2024, an ...
JD Supra5d
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 ...
Medical Device Network on MSN12d
FDA tags Medtronic embolisation device recall as Class I
Medtronic initiated the recall of certain Pipeline Vantage embolisation devices in January 2025 following reports of four ...
Mena FN25d
Medrhythms Announces FDA Class II Listing For Movivetm To Support Gait Rehabilitation And Motor Function For Parkinson's Disease
PORTLAND, Maine, March 6, 2025 /PRNewswire/ -- MedRhythms today announced that MR-005, the company's neurorehabilitation system to support gait rehabilitation and motor function in adults with ...