Outset Medical Announces Resolution of Warning Letter

Rhea-AI Summary

Outset Medical (Nasdaq: OM) announced that the FDA has confirmed all issues cited in their July 2023 Warning Letter have been successfully addressed. The medical technology company, which focuses on reducing dialysis cost and complexity through innovative technology, views this resolution as a significant milestone.

Chair and CEO Leslie Trigg emphasized the company's commitment to innovation and better dialysis outcomes, highlighting that product quality and regulatory compliance are fundamental to their success.

Positive

• FDA Warning Letter from July 2023 fully resolved
• Regulatory compliance issues successfully addressed
• Company maintains clear regulatory status for operations

Negative

• None.

SAN JOSE, Calif., Feb. 13, 2025 (GLOBE NEWSWIRE) -- Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, today announced it has been notified by the Food and Drug Administration that all issues cited in a Warning Letter the company received in July of 2023 have been addressed.

“A commitment to innovation and the advancement of better outcomes in dialysis remains at the core of Outset, which makes the quality of our products and regulatory compliance essential to our company’s success,” said Leslie Trigg, Chair and Chief Executive Officer. “We are pleased to achieve this important milestone and remain vigilant as we work to continuously improve everything we do on behalf of the patients and providers we serve.”

About Outset Medical, Inc.
Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis. The Tablo® Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally simplifies it for providers. Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by anyone. The integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission and a proprietary data analytics platform powering a new holistic approach to dialysis care. Tablo is a registered trademark of Outset Medical, Inc.

Contact
Media inquiries:
Jennifer Sipple
media@outsetmedical.com

Investor inquiries:
Jim Mazzola
jmazzola@outsetmedical.com

FAQ

What was the outcome of Outset Medical's (OM) FDA Warning Letter from July 2023?

The FDA has notified Outset Medical that all issues cited in the July 2023 Warning Letter have been fully addressed and resolved.

When did Outset Medical (OM) receive FDA clearance for their Warning Letter resolution?

Outset Medical received FDA notification of the Warning Letter resolution on February 13, 2025.

How does the FDA Warning Letter resolution impact Outset Medical's (OM) operations?

The resolution allows Outset Medical to continue operations with confirmed regulatory compliance, supporting their mission to innovate in dialysis technology.

What regulatory issues did Outset Medical (OM) resolve with the FDA?

The specific issues from the July 2023 Warning Letter were addressed to the FDA's satisfaction, though detailed issues weren't disclosed in the announcement.