San Jose, California–based Outset designed the latest version of Tablo to deliver enterprise-level security, reliability and connectivity for hospitals, health systems and home providers of dialysis.
With clearance, Tablo becomes the first hemodialysis system incorporating the FDA’s most recent guidance on medical device cybersecurity. It also features enhancements to the hardware, operating system and software. Outset said these upgrades further enhance the system’s reliability and user experience.
Outset said it architected the next-generation platform to offer enterprise-grade cybersecurity, reliability and usability. It embedded enterprise security at the hardware, software and cloud level. The company said it meets today’s hospital information technology standards.
Additional new features include a modernized operating system to accompany hardware upgrades and software advancements, all aimed at improving system performance and lengthening the time between planned maintenance in high-acuity environments. The system also has a new exterior that provides hospital-grade durability that withstands the rigors of acute environments.
Outset plans to begin shipping the next-generation Tablo to customers in the second quarter of 2026. Healthcare providers currently using Tablo can upgrade to the new cybersecurity platform.
“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, Chair and CEO. “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.”
A big step forward for Outset and Tablo
This marks a major milestone for Outset, which previously faced hurdles for the Tablo system.
In July 2023, the company announced that it received a warning letter from the FDA related to its Tablo system. The FDA said certain materials it reviewed on Outset’s website promote continuous renal replacement therapy (CRRT). That modality fell outside the listed indications for the Tablo hemodialysis system. Outset said it believes it effectively addressed this concern through labeling and promotional changes already underway.
The FDA said Outset Medical needed to seek 510(k) clearance for its TabloCart with Prefiltration, an accessory for Tablo. By August, the company announced a shipment hold for the accessory while it sought clearance.
Outset Medical began selling the TabloCart with Prefiltration in May 2024, following FDA clearance. However, days later, the company announced cost-reduction efforts that included headcount reductions, continuing the topsy-turvy run.
In February 2025, Outset announced that it resolved all issues cited in the warning letter.
