Outset Medical (Nasdaq: OM) announced today that the FDA says it addressed all issues cited in a 2023 warning letter.

Inc. (NASDAQ:OM), a medical technology company focused on innovating dialysis treatment, has resolved all concerns raised in a Warning Letter from the U.S. Food and Drug Administration (FDA) dating ...

We are pleased to achieve this important milestone and remain vigilant as we work to continuously improve everything we do on behalf of the patients and providers we serve.” About Outset Medical, Inc.

Outset Medical (OM) announced it has been notified by the FDA that all issues cited in a warning letter the company received in July of 2023 ...