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Carl Zeiss Meditec Announces USFDA Approval For Cirrus HD-OCT Software Version 4.0

Carl Zeiss Meditec has announced that it has received FDA approval for a new suite of optical coherence tomography (OCT) software applications for the Cirrus HD-OCT for commercial distribution. The Cirrus HD-OCT 4.0 with Retinal Nerve Fiber Layer and Macular Normative Databases is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures.

“Throughout our 15 year history of OCT innovation, we have seen its utility evolve from imaging of the retina to now offering both posterior and anterior capabilities,” said Michael Kaschke, PhD, President and Chief Executive Officer of Carl Zeiss Meditec. “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.”

With the most robust features for RNFL assessment available in an OCT platform, even subtle abnormalities and changes can be identified between patient visits. Cirrus HD-OCT Version 4.0 offers three tools for quantified glaucoma assessment and management:

• RNFL Normative Database helps to identify retinal nerve fiber layer (RNFL) loss.

• Anterior Segment Imaging provides visualization of the angle and measurement of central corneal thickness.

• Guided Progression Analysis (GPA) software supports glaucoma treatment decision-making by identifying statistically significant changes in RNFL thickness.

Cirrus 4.0 takes OCT imaging to a whole new level,” said Ike K. Ahmed, MD, FRCSC, Assistant Professor at the University of Toronto. “The GPA and anterior segment imaging capabilities give me increased confidence in determining whether or not my glaucoma patients are responding adequately to therapy or if they require further intervention.”

New enhancements to help clinicians better manage retinal diseases and monitor patient response to therapy are also included in Cirrus HD-OCT Version 4.0:

• Macular Change Analysis helps physicians evaluate retinal status and response to therapy by mapping changes in macular thickness.

• Fovea Finder automatically identifies the center of the fovea to ensure the accuracy of macular thickness measurements.

• Macular Thickness Normative Data allows physicians to identify retina disease based on comparison to age-matched data.

“The new Fovea Finder is a one-of-a-kind feature that obtains the precise location of each patient’s fovea as a baseline for future scans and for visual comparison of images from one appointment to the next,” said Iris Wang, MD, former Research Fellow at Baskin Palmer Eye Institute in Miami, FL. “The superb reproducibility of images along with highly sensitive macular change analysis data allows me to make more informed treatment decisions and to more closely evaluate the benefits of therapy.”

Cirrus-HD OCT software version 4.0 is DICOM compatible for use with Carl Zeiss Meditec’s connectivity solutions, including VISUPAC Star and EMR platforms.

“Carl Zeiss Meditec has played a big part in the evolution of OCT and we will continue to bring enhancements to the market in step with clinical advances to support our physician customers as well as growing patient demographics,” Kaschke added.