Outset Medical wins FDA nod for next-gen Tablo hemodialysis system

Outset Medical (Nasdaq: OM)+ announced today that it received FDA 510(k) clearance for its next-generation Tablo hemodialysis platform.

San Jose, California–based Outset designed the latest version of Tablo to deliver enterprise-level security, reliability and connectivity for hospitals, health systems and home providers of dialysis.

With clearance, Tablo becomes the first hemodialysis system incorporating the FDA’s most recent guidance on medical device cybersecurity. It also features enhancements to the hardware, operating system and software. Outset said these upgrades further enhance the system’s reliability and user experience.

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