Becker's Hospital Review

FDA expands pilot program for electronic submission of 510(k) applications

The U.S. Food and Drug Administration’s Center for Devices and Radiological Health made the CDRH eSubmissions Pilot Program available and has expanded it to include more participants. The program is a ...
Nasdaq

Medtronic Submits 510(k) Application To FDA For Interoperable Insulin Pump

(RTTNews) - Medtronic plc (MDT), Thursday announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of ...
GlobalData on MSN

HeartBeam submits 510(k) application to FDA for ECG software

HeartBeam has submitted a 510(k) application to the US Food and Drug Administration (FDA) for its 12-lead electrocardiogram ...
Morningstar

Lunit Submits 510(k) Application for Image-Based Breast Cancer Risk Prediction Model

Submission marks a key regulatory milestone toward bringing SEER-calibrated, imaging-based risk assessment to U.S. screening programs SEOUL, South Korea, Dec. 8, 2025 /PRNewswire/ -- Lunit (KRX:328130 ...