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Outset Medical rises after FDA clears upgraded dialysis system

ReutersJan 27, 2026 2:21 PM

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

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