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 (NASDAQ:OM) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=OM&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen</a>MarketBeat
- Outset Medical secures FDA clearance for Tablo haemodialysis system [Yahoo! Finance]Yahoo! Finance
- Outset Medical to Report Fourth Quarter 2025 Financial Results on Wednesday, February 11, 2026GlobeNewswire
- Outset Medical (OM) Soars 22.2%: Is Further Upside Left in the Stock? [Yahoo! Finance]Yahoo! Finance
- Download the CNN app [CNN]CNN
OM
Earnings
- 11/10/25 - Beat
OM
Sec Filings
- 1/27/26 - Form 8-K
- 1/21/26 - Form 4
- 1/21/26 - Form 4
- OM's page on the SEC website