OPTICAL COHERENCE TOMOGRAPHY: OCT wins approvals, awards

Optical coherence tomography (OCT) has racked up a number of wins recently, including regulatory approvals and awards.

For instance, Bioptigen (Research Triangle Park, NC) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to begin commercializing its handheld Envisu spectral-domain optical coherence tomography (SD-OCT) devices for diagnosing physiological and pathological conditions of the eye. The system is the first of its kind commercially available in the U.S. for handheld and pediatric imaging. Recently, the company received regulatory approval from Canadian, European, and Australian authorities as well as a grant from the National Institutes of Health (NIH) to investigate ophthalmic imaging options for premature infants and neonates.

Similarly, NinePoint Medical has earned European CE mark approval for its NvisionVLE OCT imaging system for use in diagnosing mucosa and submucosa diseases. In combination with NinePoint's achievement of ISO 13485:2003 certification for its Cambridge, MA facility, and falling on the heels of the product's FDA 510(k) clearance, the company predicts commercial launch of NvisionVLE in 2013. The company also began a clinical trial to evaluate the system's performance in imaging of Barrett's esophagus, a common precursor to esophageal cancer.

In addition, OCT won the Abbott Innovations Award at the 2012 British Society for Rheumatology's annual conference. Researchers at the National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit (Leeds, England) used Michelson Diagnostics' (Orpington, England) VivoSight topical OCT probe to quantitatively assess, in real time, patterns in collagen deposits and vascularization within the top layers of the skin that indicate scleroderma, a chronic autoimmune disease. Currently, scleroderma is diagnosed using the modified Rodnan Skin Score, which requires clinicians to qualitatively assess the thickness of skin by touching 17 sites on the body. The results presented at the conference show promise for tailored treatment and accurate data for clinical trials.

Finally, the Association for Research in Vision and Ophthalmology (ARVO) has announced that it will honor David Huang of the Oregon Health and Science University Casey Eye Institute (Portland, OR) with its 2013 Friedenwald Award, based on his pioneering work in OCT for ophthalmic imaging. The Friedenwald Award recognizes outstanding research as applied to ophthalmology; it will be presented at the 2013 ARVO Annual Meeting (May 5–9, 2013).

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