Outset Medical falls after receiving FDA's warning letter

Outset Medical

10/07/2023 14:04

** Shares of medtech co Outset Medical Inc  OM.O  fall 4.69%
 to $19.5 premarket
    ** Co in a filing late on Friday said it had received a
warning letter dated July 5 from the U.S. FDA 
     ** The first observation asserts that certain materials
reviewed by the FDA and found on co's website promote continuous
renal replacement therapy, a modality outside its dialysis
machine Tablo Hemodialysis System's current indications 
    ** Co believes the concern has been addressed through
labeling and promotional changes are underway
    ** The letter adds co's TabloCart with Prefiltration, which
is an accessory to Tablo, requires prior 510(k) clearance for
marketing authorization
    ** Co intends to work with FDA and potentially submit a
510(k) for the same
    ** The warning letter does not place any restrictions on
Tablo's US manufacturing, production or shipment, or request for
withdrawal in the market -  OM
    ** Up to last close, stock down ~21% YTD

 (Reporting by Sriparna Roy in Bengaluru)
 ((Sriparna.Roy@thomsonreuters.com;))