An expert shares four things he's learned about the 510(k) submission process that you can use to your advantage. Jon Speer As you are probably aware, a 510(k) submission is required in order to get ...

The U.S. Food and Drug Administration (FDA) has finalized its guidance “Electronic Submission Template for Medical Device 510(k) Submissions,” which will require medical device 510(k) submissions to ...

Celularity (CELU) issued a Corporate Update to Shareholders from Robert Hariri, Founder, Chairman, and CEO, which read in part, “Let me start by reiterating what we said in our announcement last week, ...

The US Food and Drug Administration is one step closer to requiring electronic submission of all premarket applications for both 510(k) and de novo medical devices, according to two newly released ...

The U.S. Food and Drug Administration (FDA) announced new Q&A draft guidance on the “Transfer of a Premarket Notification (510(k)) Clearance,” which provides information on the most frequently asked ...

Please Note: Blog posts are not selected, edited or screened by Seeking Alpha editors. Earlier today Cardium Therapeutics, an asset-based, health sciences and regenerative medicine company, announced ...