Perimeter Medical Imaging OCT system for tissue imaging receives FDA approval

May 27, 2016
Perimeter Medical Imaging has received FDA clearance for its OTIS 1.0 optical coherence tomography (OCT) system.

Medical imaging system developer Perimeter Medical Imaging (Toronto, ON, Canada) has received FDA clearance for its OTIS 1.0 optical coherence tomography (OCT) system, which provides high-resolution, real-time imaging of the periphery of excised tissue, allowing clinicians to visualize sub-surface structures up to 2 mm below the surface. These sub-surface structures would otherwise not be evident for days—and often weeks—later when conventional histology slides are available for review.

Related: Intraoperative OCT improves ophthalmic surgery

The OTIS OCT system is a platform technology for use on all excised tissue types. Working with clinical partners, the company has established a reference atlas of tissues, including thyroid, skin, breast, cervical, prostate, and ovarian, demonstrating compelling correlation between OTIS images and histology (considered the clinical gold standard). The company plans to continue expansion of the atlas now that FDA clearance has been granted. Its collaborators, including key opinion leaders from leading surgical centers in Canada and the United States, are planning use of the device in a major clinical adoption study slated to begin at the end of 2016.

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