Healthcare Industry News:  Optical Coherence Tomography 

Devices Ophthalmology FDA

 News Release - February 9, 2006

Heidelberg Engineering Receives FDA Clearance for Slit Lamp-Mounted Anterior Segment OCT

HEIDELBERG, Germany--(HSMN NewsFeed)--Feb. 9, 2006--Heidelberg Engineering GmbH has received U.S. Food and Drug Administration (FDA) clearance for the company's pioneering SL-OCT(TM) product, the world's first commercial Optical Coherence Tomography (OCT) device used for cross-sectional anterior segment imaging. The SL-OCT was first introduced in Europe, receiving CE mark certification in 2003.

The device is innovative in two ways: Not only is it the first commercial application of OCT for anterior segment imaging, but its mounting on a slit lamp offers users both space savings and cost advantages. The SL-OCT provides easy-to-use, noncontact cross-sectional scans of the anterior segment. Chamber angle, pachymetry, flap thickness, corneal curvature and comprehensive biometric measurements are possible with the instrument, as well as pre- and post-surgical comparisons.

Heidelberg Engineering is marketing two additional products in Europe based on OCT technology: OCPglobal(TM), a stand-alone pachymeter, and OCPonline(TM), an online pachymeter for integration into refractive laser systems. The online pachymeter enables refractive lasers to obtain noncontact corneal thickness measurements immediately before, during and after surgery, providing complete surgical documentation, speeding patient throughput and increasing accuracy.

"We are now the only diagnostic device company with access to the two leading technologies for diagnostic imaging: confocal scanning laser ophthalmoscopy and Optical Coherence Tomography," said Gerhard Zinser, Ph.D., managing director and head of research and development at Heidelberg Engineering. "Having access to both technologies enables us to select the right technology for the right application. For example, OCT has not been as well suited to glaucoma analysis, especially for measuring progression, due to the difficulties with OCT image alignment. We are already working on new products that combine the strengths of each technology."

About Heidelberg Engineering GmbH

Headquartered in Heidelberg, Germany, the privately-held company is the leader in light-based diagnostics for ophthalmic applications and has the world's largest installed base of laser imaging equipment. The company designs, manufactures and markets a variety of diagnostic instruments for application in retina, glaucoma and cornea diseases.

Source: Heidelberg Engineering

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