Business Wire

Pi-Cardia Receives FDA Breakthrough Device Designation for ShortCut™

REHOVOT, Israel--(BUSINESS WIRE)--Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today it ...
TCTMD

The More Tweaks Made to PMA-Approved Devices, the More Likely a Recall

Medical devices cleared under the US Food and Drug Administration’s premarket approval (PMA) pathway are more likely to undergo a recall if their manufacturers have filed additional documentation with ...
RAPS

Higher recall risk for PMA-approved devices with supplements, study suggests

High-risk medical devices whose manufacturers file supplements to the US Food and Drug Administration (FDA) so modifications can be made to the PMA-approved products are more likely to be the subject ...