Outset Medical has received the US Food and Drug Administration (FDA) 510(k) clearance for its next-generation Tablo haemodialysis system.
The clearance aligns with the FDA’s most recent guidance on medical device cybersecurity, published in June 2025, and is aimed at hospitals, health systems and home dialysis providers.
Operating system, software, and hardware enhancements have been implemented to bolster the system’s reliability and user experience.
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They are aimed at increasing the system performance while extending maintenance intervals in acute healthcare settings.
The Tablo platform aims to deliver enterprise-level cybersecurity across hardware, software and cloud layers to address hospital IT requirements.
A new exterior for the Tablo platform provides added durability suitable for hospital environments.
The company plans to begin shipping the updated platform during the second quarter of 2026. Healthcare providers using the Tablo system will be able to access upgraded cybersecurity features.
The platform is cleared for use from hospital to home settings, is deployed in more than 1,000 healthcare facilities in the US and integrates water purification with on-demand dialysate production.
It supports connectivity with electronic medical record (EHR) systems and Outset Medical’s data analytics platform.
Outset Medical chair and CEO Leslie Trigg said: “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.
“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.”
In April 2024, Outset Medical entered a multi-year agreement with US Renal Care to provide patients and caregivers access to home dialysis with the Tablo system.
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