OCT software receives FDA clearance

Dublin, CA

-Carl Zeiss Meditec has announced that a new suite of optical coherence tomography (OCT) software applications for its proprietary high-definition OCT device (Cirrus) has received FDA clearance for commercial distribution.

The 4.0 version of the software features retinal nerve fiber layer (RNFL) and macular normative databases and is indicated for in-vivo viewing and axial cross-sectional and three-dimensional imaging as well as measurement of anterior and posterior ocular structures, according to the company.

“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 [new software] 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.”

According to the company, the new software version is designed to offer the following three tools for quantified glaucoma assessment and management:
• RNFL normative database that aims to identify RNFL loss.
• Anterior segment imaging, which provides visualization of the angle and measurement of central corneal thickness.
• Proprietary analysis program (Guided Progression Analysis) to identify statistically significant changes in RNFL thickness to help physicians make decisions about treatment.

Enhancements to the previous software version can help clinicians better manage retinal diseases and monitor patient response to therapy, the company said.

The new retina-related software application features include:
• Macular change analysis, which maps changes in macular thickness.
• Fovea finder that automatically finds the center of the fovea to help ensure accuracy of macular measurements.
• Macular thickness normative data, which allow physicians to identify retina disease based on comparison with age-matched data.