Jan. 27 at 3:00 PM
Outset Medical announced FDA approval for its next-generation Tablo dialysis platform, marking a major regulatory milestone. The updated system is the first hemodialysis platform to comply with the FDA’s most stringent cybersecurity guidelines issued in June 2025, integrating enterprise-grade cybersecurity protections across hardware, software, and cloud layers.
The next-generation Tablo platform features operating system modernization, hardware upgrades, and software enhancements designed to improve performance, extend maintenance intervals, and better align with hospital IT standards. The system also includes a redesigned exterior to improve durability in demanding clinical environments. Management highlighted the approval as a reflection of the company’s commitment to patient safety, data security, and innovation.
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