FDA Clears Outset Medical's Next-Generation Tablo Hemodialysis System

Outset Medical said on January 27 that the US Food and Drug Administration has granted 510(k) clearance for a next-generation version of its Tablo hemodialysis system, a machine used for dialysis in hospitals and at home, in a release the San Jose, California, company also filed with the Securities and Exchange Commission.

In a current report on Form 8-K, Outset said it expects to begin shipping the next-generation Tablo platform to customers in the second quarter of 2026. The press release attached to the filing did not give a 510(k) number or the date of the FDA's decision.

A cybersecurity-focused redesign

According to the release, Tablo is "the first hemodialysis system incorporating FDA's most rigorous and recent guidance on medical device cybersecurity published in June 2025." That is the company's characterization. Outset said security is embedded at the hardware, software and cloud level to meet hospital information technology standards.

The company said it also modernized the operating system, upgraded hardware and changed software to improve performance and lengthen the time between planned maintenance in high-acuity settings. Trade publication Medical Device Developments reported on January 28 that the platform also has a new exterior intended to add durability in hospital environments.

"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," said Leslie Trigg, Outset's chair and chief executive, in the release.

Upgrades for existing customers

Outset said healthcare providers already using Tablo will be eligible to upgrade to the new cybersecurity platform. The company describes Tablo as combining water purification and on-demand dialysate production in a single system that connects to electronic medical records, and says it is used by more than 1,000 US healthcare facilities.

Business context

The clearance came two weeks after Outset reported unaudited preliminary results on January 12. The company said fourth-quarter 2025 revenue was approximately $28.9 million and full-year 2025 revenue approximately $119.5 million, a 5% increase over $113.7 million in 2024. It said more than 1,000 sites of care had insourced dialysis with Outset by the end of 2025, performing roughly 1 million treatments a year, and that year-end cash, including restricted cash, cash equivalents and short-term investments, was $173 million.

In that release, Trigg said the company looked forward in 2026 to "delivering new services and technologies that continue to improve patient care outcomes with lower cost and less complexity than traditional dialysis." Outset said the figures were preliminary and subject to change when it completes its year-end closing. The company did not disclose pricing for the new Tablo platform or for upgrades.