Outset Medical receives FDA 510(k) clearance for next-generation Tablo dialysis system; Q2 2026 launch

Outset Medical, Inc.

FDA 510(k) clearance granted for next-gen Tablo platform on January 27, 2026.
Tablo is first dialysis system to meet FDA's most rigorous cybersecurity guidance (June 2025).
Hardware, operating system, and software enhancements improve reliability and user experience.
Shipping to customers expected to begin in Q2 2026; current users eligible to upgrade.
CEO Leslie Trigg highlights milestone as reflecting commitment to innovation and patient safety.

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