BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith continues its investigation on behalf of Outset Medical, Inc. (“Outset Medical” or the “Company”) (NASDAQ: OM) investors concerning the Company’s possible violations of federal securities laws.
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.
If you purchased Outset securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to firstname.lastname@example.org, or visit our website at www.howardsmithlaw.com.
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