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TrueVision receives 510(k) clearance to market 3-D visualization system

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SANTA BARBARA, Calif. — TrueVision Systems has received 510(k) clearance from the U.S. Food and Drug Administration to market its TrueVision 3-D visualization and guidance system, the company announced in a press release.

Originally launched in 2008, the new version of the stereoscopic 3-D high-definition visualization system combines TrueVision's TrueWare 3-D imaging operating system with the new TrueVision refractive cataract toolset, which provides computer-aided surgical guidance for the performance of corneal limbal relaxing incisions, capsulorrhexes and toric IOL positioning, according to the release.

The new platform also enables preoperative and postoperative 3-D slit lamp image capture, the release said.

"This groundbreaking innovation is the first of its kind representing a new generation of computer guidance tools for interactive surgery," Forrest Fleming, CEO of TrueVision, said in the release. "We are very encouraged by what our initial clinical studies have shown using on-screen guidance for several important aspects of refractive cataract surgery."