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
- Analyst Sentiment on Outset Medical (OM) Remains Strong Following Q4 Results [Yahoo! Finance]Yahoo! Finance
- Outset Medical (NASDAQ:OM) had its price target lowered by analysts at BTIG Research from $17.00 to $15.00. They now have a "buy" rating on the stock.MarketBeat
- 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