Outset Medical Inc (NASDAQ:OM) experienced a notable premarket move Tuesday, with shares rising 9% after the company announced U.S. Food and Drug Administration clearance for its next-generation Tablo hemodialysis platform.
The company said the updated Tablo is the first hemodialysis platform to secure clearance under the FDA's most rigorous cybersecurity guidance, which was published in June 2025. That regulatory milestone affirms that the platform incorporates protections aligned with the FDA's highest expectations for device security.
Design and security features
Outset described the next-generation Tablo as embedding enterprise-grade cybersecurity protections across three layers: hardware, software, and cloud. The system has been engineered to interface with current hospital information technology standards while offering improved performance for dialysis treatment, according to the company.
- Hardware and exterior: The platform includes hardware upgrades and a redesigned exterior intended to increase durability for hospital use.
- Software and operating system: Operating system modernization and software advancements are intended to improve system responsiveness and reliability.
- Cloud and cybersecurity: Cloud-level protections, together with embedded safeguards at hardware and software layers, address the FDA's most demanding cybersecurity expectations.
Outset also said the platform updates are intended to extend maintenance intervals in high-acuity environments, suggesting a design focus on sustained operation where clinical demands are elevated.
Commercial timing and upgrade path
The company expects to begin shipping the next-generation Tablo to customers in the second quarter of 2026. Outset has indicated that current Tablo users will be eligible to receive upgrades to the new cybersecurity platform, offering a pathway to bring existing units in line with the cleared standard.
Outset markets Tablo as a technology aimed at improving clinical outcomes in dialysis while lowering cost and complexity for healthcare providers. The FDA clearance for the next-generation system represents a regulatory advancement for the company and its dialysis offering.
Note: This report focuses on the facts disclosed by the company about the FDA clearance, product features, shipping timeline and upgrade eligibility. It does not add information beyond those disclosures.