Outset Medical, Inc.
|Company Name||Outset Medical, Inc.|
On July 7, 2023, Outset Medical disclosed that it had received a Warning Letter from the United States Food and Drug Administration (“FDA”) which “assert[ed] that certain materials reviewed by the FDA and found on the Company’s website promote continuous renal replacement therapy (CRRT), a modality outside of the current indications for the Tablo Hemodialysis System” and that “the TabloCart with Prefiltration . . . requires prior 510(k) clearance for marketing authorization.”
On this news, Outset Medical’s stock price fell $1.20, or 5.9%, to close at $19.26 per share on July 10, 2023, thereby injuring investors.
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