Next-Generation Tablo Hemodialysis System Receives FDA Clearance, Second Quarter Launch Planned
Outset Medical, Inc. (OM)
Company Research
Source: GlobeNewswire
SAN JOSE, Calif., Jan. 27, 2026 (GLOBE NEWSWIRE) -- Outset Medical, Inc. (Nasdaq: OM), a medical technology company pioneering a first-of-its-kind technology to improve clinical outcomes in dialysis with less cost and complexity, today announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) of its next-generation Tablo platform, designed to deliver enterprise-level security, reliability and connectivity for hospitals, health systems and home providers of dialysis. With the clearance, Tablo becomes the first hemodialysis system incorporating FDA’s most rigorous and recent guidance on medical device cybersecurity published in June 2025. Additionally, enhancements to the hardware, operating system and software have been designed to further enhance Tablo’s reliability and user experience. “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, pati
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- Outset Medical, Inc. (OM) Q4 2025 Earnings Call Transcript [Seeking Alpha]Seeking Alpha
- Outset Medical outlines 5%–9% revenue growth for 2026 with next-gen Tablo launch and gross margin expansion [Seeking Alpha]Seeking Alpha
- Outset Medical Q4 Earnings Call Highlights [Yahoo! Finance]Yahoo! Finance
OM
Earnings
- 2/11/26 - Miss
OM
Sec Filings
- 3/27/26 - Form SCHEDULE
- 3/4/26 - Form 3/A
- 2/19/26 - Form 4
- OM's page on the SEC website