Outset Medical, Inc., a medical technology company focused on innovative dialysis solutions, announced that the FDA has confirmed the resolution of all issues raised in a Warning Letter the company ...
The investigation focuses on the propriety of Outset Medical’s disclosures concerning marketing authorizations and commercialization of its flagship dialysis device, the Tablo Hemodialysis System ...
SAN JOSE, Calif., Feb. 13, 2025 (GLOBE NEWSWIRE) -- Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and ...