FDA approved Perimeter Medical Imaging AI's Claire OCT System on March 3. The PMA, P250008, makes Claire the first FDA-approved AI-enabled imaging device for breast cancer surgery. Surgeons scan excised lumpectomy tissue for suspicious margins while the patient is still on the table. FDA received the application on March 13, 2025; the review took 355 days and the approval includes an authorized predetermined change control plan.
Claire pairs wide-field optical coherence tomography with a detection algorithm trained on more than 2 million OCT images of breast tissue. The supporting trial was funded by a $7.4M grant from the Cancer Prevention and Research Institute of Texas. It reported 88.1% margin accuracy and a statistically significant reduction in residual cancer versus standard of care alone. The device previously held Breakthrough Device designation. About 20% of U.S. breast-conserving surgeries end in a repeat operation, the problem Claire is meant to cut.
Perimeter, founded in 2013, trades on the TSX Venture Exchange as PINK and on OTCQX as PYNKF, with offices in Toronto and Dallas. CEO Adrian Mendes said a nationwide launch would begin within weeks, aimed at roughly 300,000 U.S. breast cancer surgeries a year. A PCCP written into the original PMA is still uncommon. For an algorithm that will keep retraining, it saves a supplement cycle every time the model moves.