Outset Medical Receives FDA Clearance for First-of-Its-Kind Tablo Hemodialysis Technology

Outset Medical, Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its next-generation Tablo hemodialysis system. 

The upgraded platform is designed to deliver enterprise-level cybersecurity, reliability, and connectivity, meeting the needs of hospitals, health systems, and home dialysis providers. 

This clearance makes Tablo the first hemodialysis system to comply with the FDA’s most recent and rigorous cybersecurity guidance, issued in June 2025, reflecting the company’s commitment to patient safety, data protection, and innovation.

The next-generation Tablo platform includes enhancements to hardware, operating system, and software, all aimed at improving system performance, reliability, and user experience. 

These improvements are intended to extend the time between planned maintenance, particularly in high-acuity clinical environments, while ensuring consistent and dependable operation. 

In addition, the platform has been designed with a hospital-grade exterior that provides enhanced durability to withstand the demands of acute care settings. 

The integration of modernised software and operating systems, combined with hardware upgrades, also supports enterprise-level connectivity and usability, ensuring healthcare providers can rely on the system for both clinical and operational needs.