FDA approves Carl Zeiss Meditec's new optical coherence tomography software

JUNE 11, 2009--Carl Zeiss Meditec (Dublin, CA) says the U.S. Food and Drug Administration (FDA) has granted clearance for commercial distribution of the company's new suite of optical coherence tomography (OCT) software. The new release supports Zeiss's Cirrus HD-OCT system; Cirrus HD-OCT 4.0 enables in vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures.

The new 4.0 version offers tools for assessing and managing glaucoma, including a retinal nerve fiber layer (RNFL) normative database, the ability to image the anterior segment, and guided progression analysis to identify statistically significant changes in RNFL thickness.

New enhancements for the management of retinal disease include macular change analysis for mapping changes in macular thickness, a fovea finder to identify the center of the fovea, as well as macular thickness normative data to identify retinal disease based on age-matched data comparisons.

The new 4.0 version also provides a macular normative database. It is DICOM compatible for use with Carl Zeiss Meditec's connectivity solutions, including VISUPAC Star and EMR platforms.

Michael Kaschke, president and CEO of Carl Zeiss Meditec, said: "Throughout our 15 year history of optical coherence tomography (OCT) innovation, we have seen its utility evolve from imaging of the retina to now offering both posterior and anterior capabilities. The Cirrus HD-OCT 4.0 incorporates the latest applications to provide eye care professionals with the tools and analyses needed to manage complex eye conditions throughout a patient's lifetime."

Carl Zeiss Meditec recently demonstrated the software suite during the 2009 American Society of Cataract and Refractive Surgery (ASCRS) meeting, held this year in San Francisco, CA. For more information on the software, see the company's ASCRS press release.

Posted by Barbara G. Goode, barbarag@pennwell.com, for BioOptics World.

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