Outset Medical, Inc. (OM)
Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Outset Medical, Inc. (“Outset Medical” or the “Company”) (NASDAQ: OM). Investors who purchased Outset Medical securities are encouraged to obtain additional information and assist the investigation.
The investigation concerns whether Outset Medical has violated federal securities laws.
On July 7, 2023, Outset 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’s stock price fell $1.20, or 5.9%, to close at $19.26 per share on July 10, 2023. Then, on October 12, 2023, healthcare company Novo Nordisk announced that one of its diabetes treatments could also be used to treat chronic kidney disease. On this news, Outset Medical’s stock price fell $2.05 per share, or 21.16%, to close at $7.64 per share on October 11, 2023.
If you are aware of any facts relating to this investigation or purchased Outset Medical shares, you can assist this investigation.You can also contact Peretz Bronstein or his law clerk and client relations manager, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC: 212-697-6484.
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