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 ...
AUSTIN, TX / ACCESSWIRE / July 7, 2020 / Apollo Endosurgery, Inc. ("Apollo") (NASDAQ:APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, announced ...
NEW YORK, April 17, 2026 (GLOBE NEWSWIRE)-- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing ...
The US Food and Drug Administration (FDA) has released a new draft guidance for its staff members and industry instructing them on how to assess the safety risks of small-bore connectors submitted ...
Recently, the U.S. Food and Drug Administration (FDA) issued final guidance on deciding when to submit a new 510(k) premarket notification application for a change to an existing medical device. 1 The ...
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 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 ...
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 ...
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