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.

CLEO:2012: Femto is fierce for cataract surgery

At CLEO:2012, happening this week in San Jose, CA, one of the show's Market Focus talks focused on the future of femtosecond lasers in cataract surgery, led by moderator Marcos Dantus (BioPhotonic Solutions; MI), whose company's femtoAdaptiv femtosecond laser won this year's CLEO/Laser Focus World Innovation Award; Arturo Chayet, MD, of the Codet Vision Institute (Mexico)--the first to ever perform all-laser LASIK surgery; Wayne Knox of the University of Rochester (NY); and Shareef Mahdavi of SM2 Strategic (CA).

Mahdavi stated in his portion of the talk that out of the 70% of procedures that use lasers, 30-40% use femtosecond lasers. As of 12/31/11, 46 of these lasers have been installed in the U.S., with more than 50% of them being used in the clinical space--a pretty powerful statistic to prove that this technology is becoming more and more accessible. What's more, 92% of those who use it recommend it, says Mahdavi.

Be sure to look for BioOptics World's upcoming May/June issue, in which Barbara Goode further delves into this utility for femtosecond lasers.