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OM.US
id: 992, Created by , Scout

Outset Medical (OM) FDA Warning Letter Case

  • In July 2023, Outset Medical (OM) disclosed having received a Warning Letter from the FDA, asserting unauthorized promotion of a treatment on the Company’s website.
  • On it, $OM fell 5.9%, losing $60M+ of shareholder value.
  • Investors may have grounds to suspect that Outset hid its regulatory problems, which led to their losses.
On July 7, 2023, Outset Medical disclosed that it had received a Warning Letter from the FDA asserting that continuous renal replacement therapy (CRRT) promoted on the Company’s website requires prior 510(k) clearance for marketing authorization.

On this news, $OM fell 5.9% and lost over $60 million of its market capitalization, seriously damaging shareholders.

Considering all the information, investors might have grounds to suspect that Outset failed to timely disclose company’s regulatory setbacks, which consequently led to their losses.

The case is already under investigation by at least one of the reputable law firms.
Alleged Offence
Misleading Statements
Failure to Disclose
Omissions
Suspected Party
Directors
Management
Security Type
Stocks
Trade Direction
Long
Shock Event Date
10 July 2023
Collecting participants…

Outset Medical Inc

Outset Medical, Inc., a medical technology company, develops a hemodialysis system for dialysis. It provides the Tablo Hemodialysis System, which comprises a compact console with integrated water p...

    Ticker
    OM.US
    ISIN
    US6901451079
    CIK
    1484612
    Sector
    Healthcare
    Industry
    Medical Devices
    Country
    USA
    Address
    3052 Orchard Drive, San Jose, CA, United States, 95134