Outset Medical (OM) Company Report

Outset Medical, Inc. (OM) announced on January 27, 2026, that its next-generation Tablo platform received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
This makes Tablo the first hemodialysis system to clear the FDA's most rigorous cybersecurity standards, published in June 2025, and includes enhancements for enterprise-grade security, reliability, and usability.
The company expects to begin shipping the next-generation Tablo platform to customers in the second quarter of 2026.

Jan 27, 2026, 2:10 PM

8-K

Outset Medical's Next-Generation Tablo Platform Receives FDA Clearance

Product Launch

New Projects/Investments

Outset Medical, Inc. (OM) announced FDA 510(k) clearance for its next-generation Tablo platform, designed for enterprise-level security, reliability, and connectivity in dialysis.
This platform is the first hemodialysis system to incorporate the FDA's rigorous guidance on medical device cybersecurity published in June 2025.
The next-generation Tablo platform is expected to begin shipping to customers in the second quarter of 2026, with current Tablo users eligible for upgrades.

Jan 27, 2026, 2:00 PM

Press Release

Outset Medical Discusses 2025 Financials and 2026 Outlook at J.P. Morgan Healthcare Conference

Guidance Update

New Projects/Investments

Revenue Acceleration/Inflection

Outset Medical, a medtech company, reported $119.5 million in total revenue for 2025, with 70% derived from recurring revenue.
The company entered 2026 with a strong balance sheet, holding $173 million in cash, and aims for cash flow breakeven and further gross margin expansion.
Outset Medical has significantly improved its gross margin from mid-negative 30s% at IPO to positive high 30s% in 2025, with a next milestone of 50% company-wide gross margin.
The company's Tablo device is used in over 1,000 hospitals in the acute and post-acute market, which accounts for 80-85% of its total revenue, and has an installed base of approximately 6,000 devices.

Jan 15, 2026, 12:30 AM

Transcript

Outset Medical Discusses 2025 Financials, Gross Margin Expansion, and 2026 Growth Strategy

Guidance Update

New Projects/Investments

Revenue Acceleration/Inflection

Outset Medical reported $119.5 million in revenue for 2025, with 70% derived from recurring revenue.
The company ended 2025 with a strong balance sheet, holding $173 million in cash, and significantly reduced cash usage to less than $50 million for the year, with a goal to reach cash flow breakeven and beyond.
Gross margin has substantially improved from negative 30% at IPO to the high 30s% in 2025, with a stated next milestone of achieving a 50% company-wide gross margin.
Outset Medical's installed base is approximately 6,000 devices, with the majority (80%-85%) in the acute market, where the company is strategically focusing due to better pricing power and utilization.
Key growth drivers for 2026 include expanding penetration within its existing customer base and pursuing new greenfield opportunities, leveraging its current presence in over 1,000 facilities.

Jan 15, 2026, 12:30 AM

Transcript

Outset Medical Discusses 2025 Financials, Market Strategy, and Future Growth at J.P. Morgan Conference

New Projects/Investments

Guidance Update

Outset Medical (OM) reported $119.5 million in revenue for 2025, with 70% derived from recurring revenue, and entered 2026 with a strong balance sheet, including $173 million in cash.
The company has a significant presence in the $2.5 billion acute and post-acute market, with over 1,000 hospitals utilizing its Tablo system for approximately one million treatments annually.
OM's Tablo system enables hospitals to insource dialysis care, leading to reported customer benefits such as a 36% reduction in ICU length of stay and a 75% reduction in CLABSI bloodstream infections.
In the home dialysis market, Outset Medical has achieved an industry-leading patient retention rate of over 90% at 90 days, with a mean patient time of approximately 1.5 years.
The company has significantly expanded its gross margin from negative 30s% at IPO to positive high 30s% by 2025, with a next milestone target of 50% company-wide gross margin.

Jan 15, 2026, 12:30 AM

Transcript

Outset Medical Reports Unaudited Q4 and Full-Year 2025 Results and Appoints New Board Member

Earnings

Board Change

Outset Medical reported unaudited revenue of approximately $28.9 million for the fourth quarter of 2025 and approximately $119.5 million for the full fiscal year 2025, representing a 5% increase over $113.7 million in 2024.
The company's year-end cash position, including restricted cash, cash equivalents, and short-term investments, totaled $173 million as of December 31, 2025.
Net cash used in operations in 2025 was below $50 million, a reduction from $116 million in 2024.
Karen N. Prange was appointed to Outset Medical's Board of Directors and its Compensation Committee, effective January 9, 2026, replacing Andrea Saia.

Jan 12, 2026, 1:31 PM

8-K

Outset Medical Reports Unaudited Q4 and Full-Year 2025 Results, Appoints New Board Member

Earnings

Board Change

Outset Medical reported unaudited revenue of approximately $28.9 million for the fourth quarter of 2025 and approximately $119.5 million for the full fiscal year 2025.
The fiscal year 2025 revenue of $119.5 million represents a 5% increase over $113.7 million in 2024.
Year-end cash, including restricted cash, cash equivalents, and short-term investments, totaled $173 million. Net cash used in operations in 2025 was below $50 million, a notable improvement from $116 million in 2024.
Karen N. Prange was appointed to Outset Medical's board of directors and its Compensation Committee, replacing Andrea Saia.

Jan 12, 2026, 1:30 PM

Press Release

Outset Medical Discusses Q3 2025 Performance, Guidance, and Strategic Initiatives

Guidance Update

Demand Weakening

Management Change

Outset Medical reported a disappointing Q3 2025 and lowered its 2025 guidance, primarily due to a delayed large console deal and a mismatch in consumable order timing.
The company is addressing persistent challenges with the predictability of capital sales through new sales processes and a change in sales leadership.
While consumable sales were impacted in Q3 2025 by customer inventory management, the company notes that Q4 2025 trends have normalized.
A key strategic focus is to increase recurring revenue and improve gross margin towards a 50% goal, with EMR integration identified as a future meaningful revenue driver.
Recent data presented at ASN Kidney Week highlighted Tablo's clinical benefits, which the company plans to emphasize in future marketing efforts to drive sales.

Nov 12, 2025, 3:40 PM

Transcript

Outset Medical Reports Q3 2025 Results and Revises Full-Year Guidance

Guidance Update

Management Change

Profit Warning

Outset Medical reported Q3 2025 revenue of $29.4 million, representing 3% year-over-year growth, and expanded non-GAAP gross margin to 39.9%.
The company revised its 2025 revenue guidance downwards to a range of $115 million-$120 million from the previous guidance of $122 million-$126 million.
This revision is primarily due to a shift in timing for several large sales opportunities, now expected to close over Q4 2025 and into 2026, and the recent resignation of the Head of Sales.
Despite the revenue shortfall, non-GAAP operating expenses declined 17% to $22.1 million, contributing to a 39% lower non-GAAP net loss of $12.4 million compared to Q3 2024.
Outset Medical ended Q3 2025 with $182 million in cash and expects to use less than $50 million of cash for the full year 2025.

Nov 10, 2025, 9:30 PM

Transcript

Outset Medical Reports Q3 2025 Results and Revises Full-Year Guidance

Earnings

Guidance Update

Management Change

Outset Medical reported Q3 2025 revenue of $29.4 million, representing 3% growth over the prior year period, and achieved a non-GAAP gross margin of 39.9%.
The company revised its 2025 revenue guidance downwards to a range of $115 million-$120 million from the previous $122 million-$126 million.
This guidance revision is primarily due to a shift in timing for several large sales opportunities, which are now expected to close in Q4 2025 and into 2026, driven by the complex approval processes of large enterprise deals.
Non-GAAP operating expenses decreased 17% to $22.1 million in Q3 2025, leading to a 35% reduction in non-GAAP operating loss to $10.4 million compared to Q3 2024.
The recent resignation of the Head of Sales was also a factor considered in the revised guidance, potentially causing internal disruption in Q4.