OCT system clearances galore

The first half of 2012 has seen a handful of optical coherence tomography (OCT) imaging systems garner U.S. Food and Drug Adminstration (FDA) clearance for clinical use, signaling what's sure to become the gold standard for imaging technology. In case you missed it, here's a short recap:

OptiMedica (Santa Clara, CA)'s Catalys Precision Laser System, one that couples OCT imaging technology with a femtosecond laser, earned its FDA clearance in January for use in capsulotomy and lens fragmentation--both ophthalmic procedures. What's more, it was CE-marked (Europe's FDA equivalent) for corneal incisions in April.

NinePoint Medical (Cambridge, MA)'s Nvision OCT system gained FDA clearance in January for endoscopic application; specifically, imaging Barrett's esophagus (which can precede esophageal cancer). The company plans to kick off clinical trials of the system this year and boost its manufacturing capabilities to support a commercial launch some time next year.

Bioptigen (Research Triangle Park, NC) has been having a busy year, too. Last week, the company received FDA clearance to begin commercializing its handheld Envisu spectral-domain optical coherence tomography (SD-OCT) devices for diagnosis of physiological and pathological conditions of the eye in patients of all ages. The system has received regulatory approval from Canadian, European, and Australian authorities already, and has even been used to remove the cataract of a 38-year-old elephant.