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Outset Medical Wins FDA Clearance for Next-Gen Tablo System

Story Highlights
  • Outset Medical gains FDA clearance for its next-generation Tablo hemodialysis platform.
  • New Tablo system sets cybersecurity benchmark and will ship from Q2 2026 with upgrade paths.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Outset Medical Wins FDA Clearance for Next-Gen Tablo System

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Outset Medical ( (OM) ) has provided an update.

On January 27, 2026, Outset Medical announced that the U.S. Food and Drug Administration granted 510(k) clearance for its next-generation Tablo hemodialysis platform, which becomes the first dialysis system to meet the FDA’s most rigorous, recently updated medical device cybersecurity standards. The upgraded Tablo system features enterprise-grade cybersecurity across hardware, software and cloud, modernized operating system and hardware to boost performance and extend maintenance intervals, and a more durable exterior suited to acute hospital environments, with shipments planned to begin in the second quarter of 2026 and existing Tablo customers eligible to upgrade, strengthening the company’s technology lead and value proposition for hospitals, health systems and home dialysis providers.

The most recent analyst rating on (OM) stock is a Hold with a $7.00 price target. To see the full list of analyst forecasts on Outset Medical stock, see the OM Stock Forecast page.

Spark’s Take on OM Stock

According to Spark, TipRanks’ AI Analyst, OM is a Neutral.

The score is held back primarily by continued losses and only moderate cash-flow progress, despite strong trailing revenue growth and sharply improved leverage. Technicals remain mixed with a pressured longer-term trend, and valuation offers limited support given the negative P/E and no dividend. Recent updates (earnings call and preliminary results) show improving margins/cash use, but guidance was lowered and execution risk persists due to sales leadership disruption and deal timing variability.

To see Spark’s full report on OM stock, click here.

More about Outset Medical

Outset Medical, Inc. is a medical technology company focused on transforming the dialysis experience across the continuum of care with its Tablo Hemodialysis System, a first-of-its-kind, FDA-cleared platform for use from hospital to home. Trusted by more than 1,000 U.S. healthcare facilities and used in millions of treatments, Tablo integrates water purification and on-demand dialysate production into a single system that connects with electronic medical records and proprietary analytics, enabling providers to run in-house dialysis programs aimed at improving operational, clinical and financial outcomes in kidney care.

Average Trading Volume: 989,796

Technical Sentiment Signal: Strong Sell

Current Market Cap: $90.12M

For an in-depth examination of OM stock, go to TipRanks’ Overview page.

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