Outset Medical Receives FDA 510(k) Clearance
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2d ago
0mins
Outset Medical announced 510(k) clearance by the U.S. Food and Drug Administration of its next-generation Tablo platform, designed to deliver enterprise-level security, reliability and connectivity for hospitals, health systems and home providers of dialysis.
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Analyst Views on OM
Wall Street analysts forecast OM stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for OM is 11.75 USD with a low forecast of 7.00 USD and a high forecast of 17.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
4 Analyst Rating
3 Buy
1 Hold
0 Sell
Strong Buy
Current: 5.025
Low
7.00
Averages
11.75
High
17.00
Current: 5.025
Low
7.00
Averages
11.75
High
17.00
About OM
Outset Medical, Inc. is a medical technology company. It offers Tablo Hemodialysis System (Tablo), which is a single enterprise solution for hemodialysis, comprised of a compact console with integrated water purification, on-demand dialysate production and advanced software and connectivity capabilities. It designed Tablo from the ground up to be a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere, and by virtually anyone. Tablo comprises various components, including Tablo Console, Tablo Cartridge, and Tablo Data Ecosystem. Tablo Console is a proprietary, compact, mobile and versatile machine consisting of an integrated water purification, on-demand dialysate production system and simple-to-use touchscreen interface with 3D animations. It also offers various key platforms, such as TabloHub, a customer-facing portal; MyTablo, a patient-facing portal, and TabloDash, an internal data analytics platform.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Outset Medical Secures FDA 510(k) Clearance for Next-Gen Tablo Platform
- FDA Clearance Milestone: Outset Medical's next-generation Tablo platform has received FDA 510(k) clearance, becoming the first hemodialysis system to comply with the latest 2025 cybersecurity guidelines, underscoring the company's leadership in medical technology innovation.
- Cybersecurity Enhancements: The new platform incorporates enterprise-grade cybersecurity at the hardware, software, and cloud levels, designed to meet modern hospital IT standards, thereby enhancing security and reliability for dialysis providers in hospitals and homes.
- Performance Improvements: With modernization of the operating system, hardware upgrades, and software enhancements, the Tablo platform's system performance is significantly improved, expected to extend the time between planned maintenance in high-acuity environments, thus increasing healthcare service efficiency.
- Market Launch Plans: The new platform is expected to begin shipping to customers in Q2 2026, with existing Tablo users eligible for upgrades to this new cybersecurity platform, further enhancing their clinical and financial outcomes.
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Outset Medical Reports Q3 Earnings Miss, Stock Plummets 48.47%
- Earnings Miss: Outset Medical reported a non-GAAP loss of -$0.69 per share for Q3 2025, missing consensus estimates by $0.03, indicating significant pressure on profitability that could undermine investor confidence.
- Revenue Decline: The company generated $29.43 million in revenue for the quarter, falling short of estimates by $1.27 million, reflecting weak sales growth that may complicate future financing efforts.
- Outlook Revision: Outset Medical revised its 2025 revenue guidance to a range of $115 million to $120 million, down from $122 million to $126 million, signaling delays in closing several large opportunities that could impact long-term strategic planning.
- Stock Plunge: Following the earnings report, Outset Medical's stock price fell by $5.85, or 48.47%, closing at $6.22, highlighting strong market concerns regarding the company's future performance.
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