News

FDA warning hits Minnesota-made infusion pumps for missing regulatory checks
Medical device maker ICU Medical changed the designs of infusion pumps made in Minnesota without properly clearing important ...
JD Supra3d
Federal Court Blocks FDA’s Final Rule on LDTs: Key Considerations for Clinical Labs
The US District Court for the Eastern District of Texas issued a pivotal ruling in the consolidated lawsuit American Clinical Laboratory ...
When AI In Medical Devices Evolves Faster Than Regulations: How Do We Keep Up?
The question is not whether AI will transform healthcare; it’s whether regulators can keep pace with that transformation.
MedTech Dive1d
Medtronic seeks FDA nod for insulin pump, furthering Abbott collab
Receiving FDA clearance would allow Medtronic to pair its pumps with a glucose monitor being developed for the company by ...
Becker's Spine Review2d
Medtronic, FDA sued over spinal cord stimulator
A Kentucky woman is suing Medtronic and the FDA alleging that the devicemaker’s spinal cord stimulator made her pain worse and that the agency didn’t diligently review updates to the implant. Angela ...
National Law Review10d
Post‑Chevron Spotlight: Federal Court Nixes FDA Rule Reclassifying Laboratory Services as Medical Devices
In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court ...
United States Army2d
New FDA guidance on artificial intelligence will help MRDC field better drugs more quickly
DHA R&D-MRDC researchers are applying the latest regulatory guidance related to AI to better carry out their mission to develop life-saving medicines.
FDA Grants Authorisation for Minder®, the First and Only Implantable Continuous EEG Monitor Approved in US
Epiminder, a pioneering medical device and information solutions company, today announced that it has been granted FDA authorisation via the De Novo classification for Minder, its proprietary ...
Medscape2d
A Pacemaker to Control BP Gets FDA Breakthrough Designation
The device is designed to lower blood pressure while simultaneously modulating the autonomic nervous system by delivering ...
STAT4d
FDA Commissioner Marty Makary announces three new hires in leadership team
The commissioner of the FDA welcomed three new leaders to the agency this week, including a new deputy commissioner.
Orchestra BioMed Shares Rally After FDA Breakthrough Approval for Blood-Pressure Device
Orchestra BioMed Holdings shares rallied premarket after the maker of medical devices said a blood-pressure mechanism received breakthrough status from the U.S. Food and Drug Administration, allowing ...