Tomophase Optical Coherence Tomography Imaging System Gets FDA OK

Tomophase Corporation of Burlington, MA has received 510(K) clearance from the FDA to bring to market its Optical Coherence Tomography Imaging System (OCTIS). The system, which can differentiate different tissue types by using near-infrared light, is to be initially used for sub-epithelial tissue visualization within the airways and lungs.
Here are some details about the technology from Tomophase’s company site:

The basis for this imaging method is that some near infrared (NIR) wavelengths can penetrate living tissues for very substantial distances. These wavelengths lie within the so-called “therapeutic window,” which also allows for some light-based therapies.
In light-based tomography, optical interferometry plays the role of optical ranging. Although optical interferometry had long been utilized in non-medical fields and known as Optical Coherence Domain Reflectometry (OCDR), not until recently did we see its first medical application in ophthalmology, a fruition of the pioneering work by J. G. Fujimoto et al. This modality has come to be known as Optical Coherence Tomography (OCT) in the arena of medical imaging.
An analogy can be drawn between OCT and ultrasound imaging in which the information carrier is sound waves instead of light. As the wavelength of the light is at least three orders of magnitude shorter than that of the sound wave, the imaging resolution of OCT is much higher, on the order of microns, making it ideal for the visualization of microanatomy and even cellular structures.

The advantages and uniqueness of Tomophase technology stem, in part, from a proprietary optical imaging engine with an optical cross-correlator that circumvents the conventional optical interferometer. The Tomophase imagine engine possesses an unique self-cancellation mechanism for the rejection of common-mode noise generated by the light sources as well as the movement of the optical fibers. As a result, our imaging engine provides superior optical signal quality compared to the conventional technology.
This optical imaging engine, coupled with our proprietary signal processing algorithm, allows us to retrieve not only the first-order tomogram, as with the conventional OCT technology, but also high-order imageries including phase-resolved tomography and differential spectral-absorbance mapping in imaged cross-sections.

Press release: Tomophase OCTIS™ Receives FDA 510(K) To Market …
Tomophase technology page…