Tomophase, a developer of the non- invasive Optical Coherence Tomography Imaging System (OCTIS) and other devices for interventional pulmonology, has received US Food and Drug Administration (FDA) 510(k) clearance to market OCTIS device.
OCTIS is comprised of a single-use disposable optical catheter and imaging console, which will be deployed for tissue imaging of airways and lungs, followed by diagnostic and therapeutic applications.
The National Lung Screening Trial (NLST) trial showed that the risk of dying from lung cancer was reduced by 20% when the former smokers were given low-dose CT scans which resulted in identifying lethal tumors at an earlier, more treatable stage.
Tomophase said OCTIS has the potential to monitor the patients by imaging pulmonary tissue following a CT scan using laser light rather than radiation.
Tomophase Chairman and CEO Peter Norris said their first 510(k) represents a giant step forward in their development of OCT technology for interventional pulmonology, heretofore a greatly underserved market.
"We plan to consistently expand our system’s capabilities in order to maximise the potential for safe, cost-effective, optical imaging, diagnostics and therapy for the management of pulmonary disease," Norris said.