An artificial intelligence-enabled imaging device designed to assist surgeons during breast cancer operations has received U.S. Food and Drug Administration (FDA) approval, according to a press release published by the device’s manufacturer, Perimeter Medical Imaging AI.
Known as Claire, the device is the first AI-enabled system approved in the United States for real-time assessment of tumor margins during breast-conserving surgery. It’s intended to help surgeons identify cancerous tissue that may not be visible using conventional techniques, with the goal of improving surgical precision.
During breast cancer surgery, surgeons aim to remove the tumor along with a surrounding margin of healthy tissue. However, determining whether all cancer has been removed can be challenging in the operating room. In many cases, patients must wait up to a week for pathology results, and if cancer is still present at the margins, additional surgery may be required.
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Claire is designed to address this gap by providing high-resolution, real-time imaging of excised tissue during surgery. The system combines optical coherence tomography with artificial intelligence to highlight areas that may contain residual cancer, allowing surgeons to make immediate decisions about whether more tissue should be removed.
The technology delivers imaging resolution 10 times higher than standard approaches such as X-ray or ultrasound and focuses on a depth considered clinically relevant for margin assessment. Its AI component has been trained using a large database of over 2 million breast tissue images to help detect subtle signs of cancer.
Data from a clinical study presented at the 26th Annual Meeting of the American Society of Breast Surgeons showed that use of the system led to a statistically significant reduction in the number of patients with residual cancer following surgery. No serious adverse effects tied to the device were reported, according to the FDA.
The company says that the device could help lower the rate of repeat procedures, which remain a common challenge in breast-conserving surgery.
“Repeat breast cancer surgeries due to residual disease remain a significant clinical, health, and economic burden,” Perimeter CEO, Adrian Mendes, said in a statement. “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.’”
Following the approval, the company plans to begin a nationwide rollout of the system, with the goal of integrating the technology into routine surgical practice and advancing the role of AI in improving cancer care outcomes.
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