Outset Medical rises after receiving FDA clearance for its dialysis machine

Outset Medical

06/05/2024 15:21

** Shares of medtech co Outset Medical  OM.O  rise 49% to
$4.69 
    ** Co receives FDA clearance for its dialysis machine called
TabloCart with prefiltration
    ** OM says it has resumed distribution of the machine and
has product available to ship to customers in the United States
     ** Co paused the shipments of its dialysis machine
TabloCart with prefiltration after receiving an FDA warning
letter in January 2023 following an inspection at its San Jose
facility
    ** "We see the FDA clearance and resumed shipment of
TabloCart with prefiltration as a big win for OM. We expect the
company to now be able to work through a customer backlog," said
BTIG analyst Marie Thibault 
   ** Including session moves, stock down 25.9% YTD

 (Reporting by Sneha S K in Bengaluru)
 ((Sneha.SK@thomsonreuters.com;))