FDA Grants Premarket Approval to AI-Enabled System for Breast Cancer Margin Assessment

Perimeter Medical Imaging AI announced it has received FDA premarket approval (PMA) for its artificial intelligence (AI)–enabled wide-field optical coherence tomography, “Claire,” the first AI-integrated imaging device indicated for intraoperative margin assessment during breast-conserving surgery.¹ The regulatory milestone marks a shift toward real-time, microscopic-scale visualization intended to reduce the high rates of reoperation associated with positive surgical margins.

Clinical Challenge of Surgical Margins

In the US, approximately 300,000 breast cancer surgeries are performed annually. Despite advances in surgical technique, the national average for re-excision remains approximately 20%, largely due to the limitations of current intraoperative assessment tools. Traditional methods, such as specimen radiography and gross touch preparation, often fail to identify microscopic residual disease at the margins. When postoperative pathology identifies malignant cells at the specimen edge, patients must undergo a second surgical procedure, which is associated with increased physical morbidity, psychological distress, compromised cosmetic outcomes, and significant healthcare costs.

The CLAIRE Trial Outcomes

The FDA approval was primarily based on results from the CLAIRE trial, which were presented at the 26^th Annual Meeting of the American Society of Breast Surgeons in May 2025.² The trial evaluated the efficacy of AI-enabled wide-field optical coherence tomography in identifying positive margins in real-time compared with the standard of care (SOC) alone.

The findings demonstrated that the AI-enabled wide-field optical coherence tomography system achieved a margin accuracy of 88.1%. Furthermore, the study met its primary end point, showing a statistically significant reduction in patients with residual cancer postsurgery compared with the SOC arm (P =.0050). The trial data demonstrated super-superiority, a regulatory threshold indicating that the treatment effect’s lower confidence interval bound exceeded a predetermined minimal clinically meaningful difference.

Technological Specifications and AI Integration

The AI-enabled wide-field optical coherence tomography system provides 3-dimensional, volumetric, cross-sectional views of excised tissue.¹ The technology utilizes light to deliver image resolution down to 10 microns—approximately 10 times higher than traditional ultrasound or X-ray and 100 times higher than standard MRI. The system specifically evaluates tissue to a depth of 2 mm, which is the clinically relevant width for margin assessment in breast oncology.

A critical component of the platform is the proprietary AI algorithm, which was trained on an image library exceeding 2 million proprietary images of both cancerous and healthy breast tissue. This algorithm acts as a computer-aided detection tool, identifying and marking focal areas suspicious for malignancy. This real-time "second set of eyes" allows surgeons to make immediate decisions regarding the need for additional cavity shaves while the patient remains in the operating room.

Implications for Surgical Oncology

"Repeat breast cancer surgeries due to residual disease remain a significant clinical, health, and economic burden," said Perimeter CEO, Adrian Mendes, in a news release. "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."

Perimeter Medical Imaging AI indicated that the system is noninvasive and requires no injectable contrast agents or oral medications, eliminating risks of drug-related adverse reactions. Following the PMA, the company plans a nationwide commercial launch to integrate the technology into high-volume surgical centers across the United States.

REFERENCES

1. Perimeter Medical Imaging AI's 'Claire' becomes first FDA-approved AI-enabled imaging device for breast cancer surgery. News release. Perimeter Medical Imaging. March 3, 2026. Accessed March 4, 2026. https://tinyurl.com/3cptem2n

2. Detailed results from B-Series OCT with ImgAssist AI 2.0 pivotal trial presented at ASBrS 2025. News release. Perimeter Medical Imaging. May 5, 2025. Accessed March 4, 2026. https://tinyurl.com/yc2ndx7y