FDA Grants Pre-Market Approval to AI Device for Breast Cancer Surgery

The FDA has granted pre-market approval to Claire (formerly known as Perimeter OCT B-Series with ImgAssist AI 2.0). This AI-imaging device will be the first in the US to be used for intraoperative breast cancer margin assessment for patients with stage 0 to III invasive ductal carcinoma and/or ductal carcinoma in situ.¹

The device will enhance the ability for surgeons to detect difficult-to-see cancer during breast-conserving surgery and may reduce the need for re-operations. Claire can deliver 10 times higher resolution than an x-ray or ultrasound at 2 mm imaging depth. The technology was developed and trained on Perimeter’s proprietary and growing OCT image library of over 2 million breast tissue images. During surgery, Claire can help to identify whether tissues should be removed prior to the procedure’s completion.

Additionally, a pre-determined change control plan was authorized as part of the pre-market approval. This will allow for AI enhancements without the need for FDA authorization or interaction. As more surgical procedures occur, Perimeter’s database expands allowing for additional data to improve the product and allow for better outcomes for future patients.

"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," said Alastair Thompson, BScHons, MBChB, MD, FRCSEd, FACS, 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 pre-market approval application. "Claire has the potential to become a new standard in breast surgical care helping reduce re-excisions while improving patient outcomes."

What Data Were Presented at the American Society of Breast Surgeons Meeting?

At the 26th Annual Meeting of the American Society of Breast Surgeons, Thompson presented comprehensive data relating to Claire.² Of 206 patients who were evaluated, 56 had residual disease margins in 17% of patients after intraoperative standard of care (SOC) alone, which consisted of a lumpectomy.

In 40% of patients, the use of Claire after SOC evaluation resulted in the correct detection of residual disease, and fully clearing 20% of additional patients from all residual disease. This met the pre-specified super-superiority performance goal for the primary end point (P = .0050).

Additionally, in the arm of the trial utilizing Claire, the mean total lumpectomy of the volume excised was 74 cm³, including 56.5 cm³ from primary lumpectomies, 14.7 cm³ from SOC shaves, and 2.8 cm³ from 115 Claire shaves. The overall Claire accuracy was 88.1%.

A total of 26 patients showed a clinical benefit rate from the identification of residual disease by Claire after SOC was completed. Of note, 6 patients who had Claire-aided shaves contained pathology-confirmed disease that was missed by SOC and histopathology at the pervious margin.

"Today, intraoperative margin assessment remains one of the most pressing problems for both surgeons and their patients. The final results of this pivotal trial clearly demonstrate that the use of [Claire] has the potential to change the current paradigm by empowering surgeons to identify regions of interest, enhance real-time intraoperative decision-making, and reduce the incidence of re-excision due to unaddressed residual disease following lumpectomy,” Thompson said during the conference presentation.

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/6ufu7ne7
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/f5jaca9x