Practical Guide to FDA Medical Device Submissions: 510(k), PMA and Exemption Pathways (WEBINAR)

The main market opportunities include navigating US regulatory pathways like 510(k), PMA, and DeNovo for medical device approvals. The modified 510(k) process encourages submission of new technologies ...
SCOTUSblog

Argument recap: Riegel v. Medtronic

Allison Zieve, arguing on behalf of the petitioner, began by discussing the PMA process and stressing what PMA is and what it isn’t. Notably, Ms. Zieve argued, the FDA grants the PMA if the ...
TCTMD

Cardiovascular Devices Make Up Largest Class of FDA Device Recalls Since 2005

While the overall percentage of medical devices approved and recalled by the US Food and Drug Administration (FDA) is relatively low, the recent increase in recalls for devices approved via the 510(k) ...
Nasdaq

United Health Products Provides Update on FDA PMA Application Process

MOUNT LAUREL, NJ - (NewMediaWire) - June 24, 2024 - United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company's FDA Premarket Approval (PMA) application process. Following the ...
Nasdaq

enVVeno Medical Submits the VenoValve PMA Application Seeking FDA Approval

Company to Host a Conference Call with the PIs Presenting the Pivotal Trial Data on Wednesday, November 20th at 2:00 PM Eastern Time - Click Here to Access IRVINE, CA / ACCESSWIRE / November 19, 2024 ...