Perimeter Medical Imaging has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Otis 1.0 optical coherence tomography (OCT) system.
The Otis system can be used as an imaging tool to assess human tissue microstructure. It helps in the two-dimensional, cross-sectional and real-time depth visualization of the tissue.
Otis system offers high-resolution and real-time imaging of the periphery of excised tissue, helping clinicians to visualize sub-surface structures up to 2 mm below the surface.
It is a platform technology that can be used on all excised tissue types, including thyroid, skin, breast, cervical, prostate and ovarian.
According to the company, the Otis is claimed to be the first FDA-cleared device to offer automated and rapid collection of OCT images.
Perimeter Medical Imaging president and CEO Paul Weber said: "Perimeter’s mission is to deliver effective, intuitive surgical tools to improve patient care.
"By providing subsurface information in real time, clinicians will have greater confidence in their assessments, leading to better accuracy in intervention."
The company develops, patents and commercializes surgical imaging tools to evaluate microscopic tissue structures during the surgical procedure.