Outset Medical

Outset Medical's Next-Generation Tablo Hemodialysis System Receives FDA Clearance with Enhanced Cybersecurity

- Outset Medical announced FDA 510(k) clearance for its next-generation Tablo hemodialysis platform, making it the first dialysis system to meet FDA's most rigorous cybersecurity guidance published in June 2025. - The enhanced platform features enterprise-grade cybersecurity embedded at hardware, software and cloud levels, along with hardware upgrades and software improvements designed to enhance reliability and user experience. - The next-generation Tablo system is expected to begin shipping to customers in the second quarter of 2026, with existing healthcare providers eligible for upgrades to the new cybersecurity platform. - Outset Medical's Tablo system is currently trusted by more than 1,000 U.S. healthcare facilities and has enabled millions of dialysis treatments across hospital and home settings.