FDA approves 1st AI-enabled imaging device for breast cancer surgery
The U.S. Food and Drug Administration has approved the first artificial intelligence-powered imaging device for breast cancer surgery.
Manufacturer Perimeter Medical Imaging announced the news on Tuesday after earning premarket approval for “Claire” (formerly the Perimeter OCT B-Series). The product also has received Breakthrough Device designation, with it designed to enhance surgeon’s ability to detect difficult-to-see cancers during surgery.
This could potentially reduce the need for repeat operations and save excess healthcare costs, the company contends.
“Repeat breast cancer surgeries due to residual disease remain a significant clinical, health and economic burden," Perimeter CEO Adrian Mendes said in a statement March 3. "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.'”
Mendes said the Dallas-based company plans to roll out the product nationwide in the coming weeks. Claire combines proprietary AI with wide-field OCT imaging, enabling high-res, real-time evaluation of excised tumor margins. The system purportedly can deliver 10 times higher resolution when compared to standard X-ray and ultrasound.
Claire was previously tested in a clinical trial, which demonstrated 88.1% margin accuracy and a statistically significant reduction in patients with residual post-surgery cancer. Perimeter estimates that about 20% of breast cancer surgeries are repeated in the U.S.
The product’s AI engine was trained on “millions” of proprietary OCT images of cancerous and healthy tissue. Every surgical procedure performed with Claire generates new data, which can be used to improve performance. Perimeter says Claire is one of a select few AI-enabled, Class 3 devices on the U.S. market today. The company was required to submit a predetermined change control plan as part of gaining approval, which details planned AI enhancements to be implemented without further FDA action.
"Developing AI for clinical use is incredibly challenging, requiring large, high-quality datasets that reflect real-life patient diversity," Perimeter Chief Innovation Officer and Co-founder Andrew Berkeley said in the announcement. "This approval reflects years of hard work with our clinical partners integrating AI directly into surgical decision-making and advancing its role from operational support to real-time patient care."
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.