The US Food and Drug Administration (FDA) has granted a breakthrough device designation to Perimeter Medical Imaging AI’s Optical Coherence Tomography (OCT) Imaging System coupled with ImgAssist AI.

The OCT system offers clinicians real-time, ultra-high-resolution, sub-surface image volumes of the margin (1-2mm below the surface) of an excised tissue specimen.

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For decision making during a clinical procedure, visualisation of microscopic tissue structures, along with the standard of care tissue analysis, could possibly enhance long-term outcomes for patients. It could also reduce costs to the healthcare system.

The FDA cleared the system as an imaging tool in the evaluation of excised human tissue microstructure by offering two-dimensional, cross-sectional, real-time depth visualisation.

Perimeter Medical Imaging co-founder Liz Munro said: “We are thrilled that FDA has granted breakthrough device designation for our OCT Imaging System with ImgAssist AI, recognising the potential of our device to offer significant advantages over existing alternatives for intra-operative evaluation of margins during breast cancer lumpectomy.”

With a $7.4m grant from the Cancer Prevention and Research Institute of Texas, the company is currently advancing its next-gen AI technology and machine learning tools to clinical development under the ATLAS AI project.

Perimeter Medical Imaging CEO Jeremy Sobotta said: “Achieving a breakthrough device designation from the FDA further validates our strong belief that Perimeter’s novel OCT Imaging System combined with AI has the potential to be a transformative, disruptive new technology aimed at helping surgeons treat breast cancer.

“This breakthrough designation, combined with the Centers for Medicare & Medicaid Services’ (CMS) initiatives around Medicare Coverage of Innovative Technology (MCIT), have the potential to provide a pathway to expediting adoption of this innovative technology.”