Outset Medical Inc. has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation Tablo platform, which is designed to deliver enterprise-level security, reliability, and connectivity for hospitals, health systems, and home dialysis providers.

With the clearance, Tablo becomes the first hemodialysis system to incorporate the FDA’s most rigorous and recent guidance on medical device cybersecurity, published in June 2025. Additionally, enhancements to the hardware, operating system, and software have been designed to further enhance Tablo’s reliability and user experience.

“We are proud to be the first dialysis company to clear the high standard for cybersecurity set by the FDA—a milestone that reflects Outset’s ongoing commitment to innovation, patient safety, and data stewardship,” Outset Medical Chair/CEO Leslie Trigg stated. “Our next-generation platform is designed to protect and amplify the clinical, financial, and operational value delivered to our customers, and extend Outset’s technology lead.”

The new Tablo platform is specifically built to offer enterprise-grade cybersecurity, reliability, and usability.

• Enterprise Cybersecurity: Security is embedded at the hardware, software, and cloud level; it is designed to meet current hospital information technology standards.
• Device Performance: Operating system modernization, hardware upgrades, and software advancements improve system performance and are designed to lengthen the time between planned maintenance in high-acuity environments.
• Exterior Enhancements: A new exterior aimed at providing hospital-grade durability that withstands the rigors of acute environments.

The next-generation Tablo platform is expected to begin shipping to customers in the second quarter this year. Healthcare providers currently using Tablo can upgrade to the new cybersecurity platform.

Outset is a medical technology company transforming the dialysis experience across the continuum of care with a first-of-its-kind technology. The Tablo Hemodialysis System, FDA-cleared for use from hospital to home, has enabled millions of treatments delivered by thousands of nurses. Designed to reduce the cost and complexity of dialysis, Tablo combines water purification and on-demand dialysate production into a single, integrated system that connects seamlessly with electronic medical record systems and a proprietary data analytics platform. This enterprise solution empowers providers to develop an in-house dialysis program where they are in control—enabling better operational, clinical, and financial outcomes.