CenterVue gains FDA 510(k) clearance

San Jose, CA-FDA 510(k) clearance has been granted to CenterVue’s next-generation Macular Integrity Assessment (MAIA).

The product offers advances in scanning laser ophthalmoscopy confocal microperimetry. The tool is able to detect, describe, and follow-up pathologies affecting the macular area, including those that represent the leading causes of blindness.

CenterVue’s device is intended for measuring macular sensitivity, fixation stability, and the focus of the fixation, as well as providing infrared retinal imaging. It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.

“FDA clearance of (our product) represents significant opportunities for eye-care professionals,” said Cliff Wright, OD, chief executive officer of CenterVue. “Through the device’s combined structure-function analysis, (it) is an essential tool for a variety of retinal diseases.

“From diagnosis, to monitoring progression of both retinal pathologies and treatment efficacy, the (device) is the first eye-to-use microperimetry and represents a significant advance in macular functional analysis,” he added.

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