
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