Outset Medical rises after FDA clears upgraded dialysis system

Outset Medical

27/01/2026 14:21

** Shares of medical device maker Outset Medical OM.O rise 8% to $5.30 premarket

** Co says the U.S. FDA cleared its next-generation dialysis system, Tablo, which has added reliability features

** Adds that Tablo's upgraded cybersecurity meets the FDA's latest standards

** Tablo is used for hemodialysis — a treatment that filters waste from the blood when kidneys fail

** Co says hardware and software updates are aimed at cutting maintenance needs and improving durability in hospitals

** Shipments of the new system to begin in Q2 2026; existing users can upgrade

** Shares fell ~78% in 2025

 (Reporting by Sahil Pandey in Bengaluru)

 ((Sahil.Pandey@thomsonreuters.com))