Outset Medical secures FDA clearance for Tablo haemodialysis system [Yahoo! Finance]
Outset Medical, Inc. (OM)
Company Research
Source: Yahoo! Finance
The clearance aligns with the FDA's most recent guidance on medical device cybersecurity, published in June 2025, and is aimed at hospitals, health systems and home dialysis providers. Operating system, software, and hardware enhancements have been implemented to bolster the system's reliability and user experience. They are aimed at increasing the system performance while extending maintenance intervals in acute healthcare settings. The Tablo platform aims to deliver enterprise-level cybersecurity across hardware, software and cloud layers to address hospital IT requirements. A new exterior for the Tablo platform provides added durability suitable for hospital environments. The company plans to begin shipping the updated platform during the second quarter of 2026. Healthcare providers using the Tablo system will be able to access upgraded cybersecurity features. The platform is cleared for use from hospital to home settings, is deployed in more than 1,000 healthcare faci
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News
- 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
- Next-Generation Tablo Hemodialysis System Receives FDA Clearance, Second Quarter Launch PlannedGlobeNewswire
- 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