OM Stock Gains on FDA Clearance for Next-Gen Tablo Dialysis System

Outset Medical, Inc. OM recently announced that its next-generation Tablo hemodialysis system has received 510(k) clearance, marking a key regulatory milestone for the company. The clearance positions Tablo as the first dialysis system to meet the FDA’s most stringent and up-to-date cybersecurity standards, reinforcing OM’s technology leadership in a highly regulated market.

The upgraded Tablo platform brings meaningful enhancements across cybersecurity, reliability and usability, aimed at hospitals, health systems and home dialysis providers.

Likely Trend of OM Stock Following the News

Following the announcement, the company's shares gained 14.3% at yesterday’s trading session. However, in the last six-month period, shares have lost 68.6% compared with the industry’s 19.8% decline. The S&P 500 has gained 11.4% in the same time frame.

Over the long run, this clearance helps OM by making Tablo easier to adopt for hospitals and health systems that prioritize security, reliability and regulatory compliance. Meeting the FDA’s latest cybersecurity standards reduces risk concerns for buyers, supports upgrades within the existing customer base, and strengthens OM’s position as a credible, long-term partner, which can gradually translate into steadier adoption and revenue visibility.

OM currently has a market capitalization of $90.2 million.

More on the News

The next-generation Tablo platform has been redesigned with a strong focus on enterprise-level needs, particularly for large hospital systems operating in high-acuity settings. Security is embedded across the full technology stack—hardware, software and cloud—allowing the system to align with modern hospital IT requirements rather than relying on add-on protections. Alongside cybersecurity, OM has modernized the operating system and upgraded key hardware components, resulting in improved overall performance and greater system reliability, which is expected to extend the time between scheduled maintenance.

In addition, Outset Medical has introduced exterior enhancements to improve durability, making the system better suited to withstand the daily wear and tear of acute-care environments. The company expects the new Tablo platform to begin shipping to customers in the second quarter of 2026. Importantly, existing Tablo users will be eligible to upgrade to the new cybersecurity platform, creating a clear pathway for OM to refresh its installed base while maintaining continuity for current customers.

More on the Tablo Hemodialysis Platform

The Tablo hemodialysis platform is designed to simplify dialysis by integrating water purification, on-demand dialysate production and treatment delivery into a single, compact system. Built for use across hospitals, outpatient centers and home settings, Tablo aims to reduce setup complexity, lower operational burden for providers and deliver a more consistent, patient-centric dialysis experience.

A Recent Development by OM

In November 2025, OM announced new research findings based on more than 1 million Tablo hemodialysis treatments conducted across roughly 750 facilities, alongside five-year outcomes from a large Florida hospital that insourced dialysis using Tablo. The data, to be presented at the American Society of Nephrology’s Kidney Week 2025, highlighted strong clinical outcomes, including a 94% reduction in serious cardiac or respiratory events at AdventHealth’s Ocala site, high staff satisfaction and retention, and consistent achievement of treatment goals across long-duration and high-acuity dialysis cases.

OM’s Zacks Rank & Key Picks

Currently, OM carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are IDEXX Laboratories IDXX, Boston Scientific BSX and STERIS STE. Each stock presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Estimates for IDEXX’s 2025 earnings per share (EPS) have remained constant at $12.93 in the past 30 days. Shares of the company have risen 12.6% in the past year compared with the industry’s 11.1% growth. IDXX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 7.1%. In the last reported quarter, it delivered an earnings surprise of 8.3%.  

Boston Scientific shares have gained 2.9% in the past year. Estimates for the company’s 2025 EPS have remained constant at $3.04 in the past 30 days. BSX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 7.4%. In the last reported quarter, it posted an earnings surprise of 5.6%.

STERIS shares have risen 9.1% in the past year. Estimates for the company’s 2025 EPS have increased by 2 cents to $10.23 in the past 30 days. STE’s earnings topped estimates in three of the trailing four quarters and matched on one occasion, delivering an average surprise of 2.6%. In the last reported quarter, it posted an earnings surprise of 2.6%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research