Topcon granted FDA clearance for OCT measurement software

Paramus, NJ

-Topcon Medical Systems has received FDA clearance for its enhanced 3D optical coherence tomography (OCT) measurement software (OCT-1000 TrueMap) as an addition to its previously cleared OCT system (3D OCT-1000), according to a prepared statement.

The software, according to the company, is designed to allow physicians to visualize four layers of the retina: the inner limiting membrane, the IS/OS junction, the retinal pigment epithelium, and Bruch’s membrane. The software also can import and read data from a time-domain OCT device (Stratus, Carl Zeiss Meditec).

The software upgrade package is included in the price of the system’s warranty, so systems that currently are under warranty will be upgraded to the enhanced software at no additional charge to the customer, according to the company.