B-Series OCT with ImgAssist AI (Claire)
Breast-Conserving Surgery (AI-assisted margin assessment)
PMA ReviewPMA Application Submitted
Key Facts
Indication
Breast-Conserving Surgery (AI-assisted margin assessment)
Phase
PMA Review
Status
PMA Application Submitted
Company
About Perimeter Medical Imaging AI
Perimeter Medical Imaging AI's mission is to transform cancer surgery by providing real-time, high-resolution visualization of surgical margins. The company has achieved a significant milestone with the FDA Premarket Approval (PMA) submission for its next-generation B-Series OCT with ImgAssist AI, following positive pivotal trial results demonstrating a statistically significant reduction in residual cancer. Its strategy focuses on commercializing its AI-enabled OCT platform initially in breast-conserving surgery, with a clear path to expand into other solid tumor indications.
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