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 ...
TCT Magazine

Cairn Surgical submits De Novo 510(k) FDA application for 3D printing-enabled Breast Cancer Locator System

A medical device can be designated for the De Novo pathway when it offers novel technology with a reasonable assurance of ...

Cairn Surgical Announces FDA De Novo 510(k) Submission for Breast Cancer Locator System

Cairn Surgical announces FDA submission of a De Novo 510(k) application for its Breast Cancer Locator (BCL) System.
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 ...