Next-Generation Tablo Hemodialysis System Receives FDA Clearance, Second Quarter Launch Planned

Rhea-AI Summary

Outset Medical (Nasdaq: OM) announced FDA 510(k) clearance for its next-generation Tablo hemodialysis platform on Jan 27, 2026. The platform is the first dialysis system cleared to meet the FDA's June 2025 guidance on medical device cybersecurity and includes hardware, operating system, and software enhancements to improve reliability, performance, and durability. The next-generation Tablo is expected to begin shipping to customers in Q2 2026, and existing Tablo users will be eligible for an upgrade to the new cybersecurity platform.

Positive

• FDA 510(k) clearance for next-generation Tablo (Jan 27, 2026)
• First dialysis system cleared to meet FDA June 2025 cybersecurity guidance
• Planned customer shipments beginning Q2 2026
• Existing Tablo users eligible to upgrade to the new cybersecurity platform
• Platform enhancements: hardware, OS, and software to improve performance and reliability

Negative

• None.

Key Figures

Regulatory pathway: 510(k) clearance Launch timing: Second quarter 2026 Cybersecurity guidance date: June 2025

3 metrics

Regulatory pathway 510(k) clearance Next-generation Tablo hemodialysis system

Launch timing Second quarter 2026 Next-generation Tablo platform expected customer shipments

Cybersecurity guidance date June 2025 FDA medical device cybersecurity guidance referenced in clearance

Market Reality Check

Price: $5.68 Vol: Volume 254,514 is about 0...

low vol

$5.68 Last Close

Volume Volume 254,514 is about 0.14x the 20-day average of 1,772,975, indicating muted trading versus typical activity. low

Technical Price at $4.97 is trading below the 200-day MA of $12.64, well off the $21.98 52-week high.

Peers on Argus

Peers show mixed moves: BSGM up 39.91%, while CATX, NNOX, and QSI are down betwe...

Peers show mixed moves: BSGM up 39.91%, while CATX, NNOX, and QSI are down between -3.2% and -8.51%, and VMD is modestly higher, suggesting stock-specific dynamics for OM rather than a unified sector move.

Previous Clinical trial,fda approval Reports

1 past event · Latest: May 06 (Positive)

Same Type Pattern 1 events

Date	Event	Sentiment	Move	Catalyst
May 06	FDA device clearance	Positive	+20.7%	FDA 510(k) clearance for TabloCart with prefiltration accessory.

Pattern Detected

Prior FDA/clinical clearance news for Tablo was followed by a strongly positive price reaction.

Recent Company History

This announcement adds to Outset Medical’s track record of regulatory progress around the Tablo platform. A prior FDA 510(k) clearance for TabloCart with prefiltration on May 6, 2024 coincided with a 20.7% move, indicating past market sensitivity to similar approvals. Together with more recent financial updates showing revenue growth and ongoing Tablo adoption, the new next‑generation system clearance reinforces a theme of iterative product and platform enhancement.

Historical Comparison

clinical trial,fda approval

+20.7 %

Average Historical Move

Historical Analysis

Past FDA/clinical clearance news for OM (1 event) saw an average 20.7% move, framing today’s Tablo system clearance within a history of strong reactions.

Typical Pattern

Both the prior and current tagged events involve FDA <b>510(k)</b> clearances expanding capabilities of the Tablo hemodialysis platform, reflecting ongoing product evolution.

Market Pulse Summary

This announcement highlights FDA 510(k) clearance for Outset Medical’s next-generation Tablo hemodia...

Analysis

This announcement highlights FDA 510(k) clearance for Outset Medical’s next-generation Tablo hemodialysis system, emphasizing enhanced cybersecurity, reliability, and usability with an expected launch in the second quarter of 2026. Historically, similar Tablo-related clearances have coincided with a 20.7% move, underscoring the potential importance of regulatory milestones. Investors may watch execution on the rollout, upgrade uptake among existing Tablo users, and subsequent financial updates to gauge the platform’s commercial impact.

Key Terms

510(k) clearance, hemodialysis, cybersecurity

3 terms

510(k) clearance regulatory

"today announced 510(k) clearance by the U.S. Food and Drug Administration (FDA)"

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

hemodialysis medical

"Tablo Hemodialysis System, improving clinical outcomes in dialysis"

Hemodialysis is a medical treatment that cleans a person’s blood when their kidneys can no longer do the job, by routing blood through a machine that filters out waste, excess fluid and adjusts salt levels—think of it as an external, mechanical kidney. It matters to investors because it drives demand for specialized machines, replacement filters, clinics, trained staff and related drugs, and is sensitive to reimbursement rules, treatment volumes and advances that can change costs or market share.

cybersecurity technical

"first dialysis system to clear FDA’s most rigorous cybersecurity standards"

Cybersecurity involves protecting computers, networks, and digital information from theft, damage, or unauthorized access. It is essential for safeguarding sensitive data and maintaining trust in digital systems, which matters to investors because strong cybersecurity reduces the risk of costly breaches and disruptions that can impact a company’s performance and reputation. Think of it as locking and safeguarding valuable information much like securing a safe to prevent theft.

AI-generated analysis. Not financial advice.

Tablo becomes first dialysis system to clear FDA’s most rigorous cybersecurity standards

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, patient safety and data stewardship,” said Leslie Trigg, Chair and CEO. “Our next-generation platform is designed to protect and amplify the clinical, financial and operational value delivered to our customers, and extend Outset’s technology lead.”

Next-Generation Tablo Platform
The new Tablo platform is architected to offer enterprise-grade cybersecurity, reliability, and usability.

• Enterprise Cybersecurity: Security is embedded at the hardware, software and cloud level designed to meet today’s hospital information technology standards.
• Device Performance: Operating system modernization, hardware upgrades and software advancements improve system performance and are designed to lengthen the time between planned maintenance in high-acuity environments.
• Exterior Enhancements: A new exterior aimed at providing hospital-grade durability that withstands the rigors of acute environments.
  

The next-generation Tablo platform is expected to begin shipping to customers in the second quarter of 2026. Healthcare providers currently using Tablo will be eligible to upgrade to the new cybersecurity platform.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, without limitation, statements regarding the anticipated launch and timing of product enhancements and new features, as well as new or expanded services, and the expected benefits, performance, and impact thereof. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, and are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, which could cause actual results and other events to differ materially from those expressed or implied in such statements. These risks and uncertainties include risks described in the Risk Factors section of Outset’s public filings with the U.S. Securities and Exchange Commission, including its latest annual and quarterly reports. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Outset disclaims any obligation to update these forward-looking statements.

About Outset Medical, Inc.
Outset is a medical technology company transforming the dialysis experience across the continuum of care with a first-of-its-kind technology. The Tablo® Hemodialysis System, FDA-cleared for use from hospital to home, is trusted by more than 1,000 U.S. healthcare facilities and has enabled millions of treatments delivered by thousands of nurses. Designed to reduce the cost and complexity of dialysis, Tablo combines water purification and on-demand dialysate production into a single, integrated system that connects seamlessly with Electronic Medical Record systems and a proprietary data analytics platform. This enterprise solution empowers providers to develop an in-house dialysis program where they are in control – enabling better operational, clinical, and financial outcomes. Outset is redefining what’s possible in kidney care through innovation, scale, and a relentless commitment to improving the lives of patients and the professionals who care for them. For more information, visit www.outsetmedical.com.

Investor Contact
Jim Mazzola
jmazzola@outsetmedical.com

FAQ

What did Outset Medical (OM) announce about the next-generation Tablo on Jan 27, 2026?

Outset Medical announced FDA 510(k) clearance for its next-generation Tablo platform, citing enterprise-grade cybersecurity, reliability, and usability enhancements.

Why is the Jan 27, 2026 FDA clearance for Tablo significant for cybersecurity?

Tablo became the first dialysis system cleared to meet the FDA's most recent cybersecurity guidance published in June 2025.

When will the next-generation Tablo begin shipping to customers (OM)?

The next-generation Tablo platform is expected to begin shipping to customers in Q2 2026.

Can current Tablo customers upgrade to the new cybersecurity platform?

Yes. Healthcare providers currently using Tablo will be eligible to upgrade to the new cybersecurity platform.

What technical improvements does the next-generation Tablo include?

The platform includes hardware, operating system, and software enhancements plus an exterior redesign to improve performance, maintenance intervals, and hospital-grade durability.