Perimeter submits Premarket Approval application with FDA for Perimeter B-Series OCT system

(Image Credit: AdobeStock/Eugene Ga)

Perimeter Medical Imaging AI has submitted a Premarket Approval (PMA) application to the US Food and Drug Administration (FDA) for its Perimeter B-Series OCT system.

The Perimeter B-Series OCT system combines proprietary artificial intelligence (AI) technology with optical coherence tomography (OCT) for use during breast-conserving surgeries.

Perimeter's CEO, Adrian Mendes, commented on the submission in a press release from the company.¹

"The FDA PMA submission is a major milestone—our first regulatory approval application for our AI-enabled wide-field OCT technology, as well as for a specific indication label," said Mendes. "The ultimate product promise of B-Series OCT with ImgAssist AI 2.0 is greater peace of mind. Both for the surgeon, who, no matter how skilled, currently faces nearly 1-in-5 odds of needing to perform repeat surgery due to positive margins, and for their patient, who, under the current paradigm, typically has to wait (and worry) for up to seven days for their surgeon to receive a post-operative pathology report which will determine whether they will have to go through the emotional and physical trauma of a second surgery due to cancer left behind.”

The ImgAssist AI 2.0 is a proprietary tool from Perimeter that “separates each image into a patch, [does] an analysis on the patch, and [gives] it a confidence level,” Andrew Berkeley, co-founder and chief innovation officer at Perimeter, previously told Ophthalmology Times.²

In November 2024, Perimeter released data from a clinical of the Perimeter B-Series OCT with ImgAssist AI 2.0 that showed a statistically significant reduction in patients with residual cancer during surgery.

The prospective, multicenter, randomized, clinical trial enrolled 206 patients with breast cancer undergoing lumpectomy for the treatment of Stage 0-III invasive ductal carcinoma and/or ductal carcinoma in situ. Patients were evaluated to measure the effectiveness of the combined B-Series OCT imaging system with ImgAssist AI 2.0 compared with lumpectomy current standard methods including palpation, specimen radiograph, intraoperative pathology, and ultrasound in addressing positive margins.

According to the results, the B-Series OCT with ImgAssist AI 2.0 enabled surgeons to more effectively address residual cancer at the surgical margin during surgery as compared with current standard methods.

Reference:

1. Perimeter Files FDA PMA Application for its Next-Generation B-Series OCT with ImgAssist AI 2.0. Published March 17, 2025. Accessed March 17, 2025.https://ir.perimetermed.com/news-events/press-releases/detail/167/perimeter-files-fda-pma-application-for-its-next-generation

2. Harp. M. From eye care to cancer care: Expanding role of OCT imaging. Ophthalmology Times. November 27, 2024. https://www.ophthalmologytimes.com/view/from-eye-care-to-cancer-care-expanding-role-of-oct-imaging