Perimeter Medical Imaging AI's 'Claire' Becomes First FDA-approved AI-Enabled Imaging Device for Breast Cancer Surgery

Claire demonstrated a statistically significant reduction in patients with residual cancer post-surgery compared to the standard of care alone

Mar. 3, 2026 at 10:51pm

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Perimeter Medical Imaging AI, Inc. announced that it has received U.S. Food and Drug Administration (FDA) premarket approval for Claire, the first AI-enabled imaging device approved in the United States for intraoperative breast cancer margin assessment. Claire combines Perimeter's proprietary AI with its patented wide-field OCT imaging to enable high-resolution, real-time evaluation of excised tumor margins, with the goal of reducing repeat surgeries for breast cancer patients.

Why it matters

Repeat breast cancer surgeries due to residual disease remain a significant clinical, health, and economic burden. Claire's FDA approval marks a major milestone in breast cancer care, as it advances the goal of reducing repeat surgeries so that no patient has to be told 'we didn't get it all.' The technology has the potential to become a new standard in breast surgical care, helping reduce re-excisions while improving patient outcomes.

The details

Claire's pivotal trial demonstrated an 88.1% margin accuracy and a statistically significant reduction in patients with residual cancer post-surgery compared to the standard of care alone. The technology uses AI trained on Perimeter's proprietary and growing OCT image library of over 2 million breast tissue images to identify areas of concern during surgery, helping surgeons determine whether to remove more tissue before completing the procedure.

  • Perimeter received FDA premarket approval for Claire on March 3, 2026.

The players

Perimeter Medical Imaging AI, Inc.

A commercial-stage medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools.

Adrian Mendes

The CEO of Perimeter Medical Imaging AI, Inc.

Dr. Alastair Thompson

Surgeon and Professor, Section Chief of Breast Surgery, Olga Keith Wiess Chair of Surgery at Baylor College of Medicine, Breast Cancer Program Leader at the Dan L Duncan Comprehensive Cancer Center, and the Primary Principal Investigator of the pivotal trial that supported Claire's PMA application.

Andrew Berkeley

The Chief Innovation Officer and co-founder of Perimeter Medical Imaging AI, Inc.

Chamath Palihapitiya

A renowned Silicon Valley venture capitalist, entrepreneur, and former Facebook executive who has been a major investor in Perimeter for several years.

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What they’re saying

“Repeat breast cancer surgeries due to residual disease remain a significant clinical, health, and economic burden. Claire's FDA approval marks a major milestone in breast cancer care, as we advance our goal of reducing repeat surgeries so that no patient has to be told 'we didn't get it all.' We plan to begin a nationwide launch in the coming weeks so that surgeons can rapidly adopt the industry's first FDA-approved real-time AI-powered imaging technology for breast cancer surgery.”

— Adrian Mendes, CEO, Perimeter Medical Imaging AI, Inc.

“Despite progress in breast cancer treatment, intra-operative margin assessment remains challenging, often leading to excess removal of healthy tissue, re-operations, and anxiety for patients as they await pathology results. Claire has the potential to become a new standard in breast surgical care helping reduce re-excisions while improving patient outcomes.”

— Dr. Alastair Thompson, Surgeon and Professor, Section Chief of Breast Surgery, Olga Keith Wiess Chair of Surgery at Baylor College of Medicine, Breast Cancer Program Leader at the Dan L Duncan Comprehensive Cancer Center, and the Primary Principal Investigator of the pivotal trial that supported Claire's PMA application

“Developing AI for clinical use is incredibly challenging, requiring large, high-quality datasets that reflect real-life patient diversity. This approval reflects years of hard work with our clinical partners integrating AI directly into surgical decision-making and advancing its role from operational support to real-time patient care.”

— Andrew Berkeley, Chief Innovation Officer and co-founder, Perimeter Medical Imaging AI, Inc.

“I've been a major investor in Perimeter for several years, and it's been the incredible clinical and commercial potential of Claire that has driven my excitement all along. After rigorous development, clinical and regulatory engagement, and collaboration with the medical community, I believe Perimeter is at the starting line of something truly transformational.”

— Chamath Palihapitiya

“Claire delivers greater peace of mind. Both for the surgeon who currently faces nearly 1-in-5 odds of needing to perform repeat surgery due to positive margins, and for the breast cancer patient, who, under the current paradigm, typically has to wait (and worry) for up to 10 days to learn whether an additional surgery is required. A second surgery is an emotional and physical journey that we are trying to prevent. This is exactly the kind of AI-driven innovation that can improve the standard of care by delivering measurable, real-world medical impacts.”

— Chamath Palihapitiya

What’s next

Perimeter plans to begin a nationwide launch of Claire in the coming weeks so that surgeons can rapidly adopt the industry's first FDA-approved real-time AI-powered imaging technology for breast cancer surgery.

The takeaway

Claire's FDA approval represents a major milestone in breast cancer care, as it has the potential to become a new standard in surgical care by reducing repeat surgeries and improving patient outcomes through the use of innovative AI-powered imaging technology.