Optical Coherence Tomography Imaging System Designed for Lung Cancer Patients

(Burlington, MA, USA), developer of the noninvasive OCTIS and other devices, announced that it has received US Food and Drug Administration (FDA) 510(k) clearance to market OCTIS.

Tomophase is a developer of OCT brochoscopically-based imaging systems for interventional pulmonology. OCTIS is comprised of a single-use disposable optical catheter and imaging console. Initially OCTIS will be deployed for tissue imaging of airways and lungs, followed by diagnostic and therapeutic applications.

The US National Lung Screening Trial (NLST) recently released by the NCI represents an example of how OCT will be applied. In the NLST, the risk of dying from lung cancer was reduced by 20% when the subjects (> 50,000), former smokers, were given low-dose CT scans that resulted in identifying deadly tumors at an earlier, more treatable stage.

"We are delighted to receive the 510(k) for our new, novel OCT imaging system. This clearance reflects the hard work and dedication of our employees and consultants over the past five years. At the present time, there is a lot of excitement in interventional pulmonology due to the emergence of several new innovative, medical technologies and potential applications. Our company is committed to providing new medical imaging products to improve the diagnosis and treatment of diseases of the lung and airways including asthma, emphysema, and lung cancer,” said Ralph Johnston, president and COO.

Dr. Peter Norris, chairman and CEO added, "Our first 510(k) represents a giant step forward in our development of OCT technology for interventional pulmonology, heretofore a greatly underserved market. We plan to consistently expand our system's capabilities in order to maximize the potential for safe, cost-effective, optical imaging, diagnostics, and therapy for the management of pulmonary disease.”

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