CenterVue's next generation Macular Integrity Assessment receives FDA clearance

Jun 4 2014

CenterVue, Inc. (www.centervue.com), a leader in the design and manufacture of highly automated medical devices for the diagnosis and management of ocular pathologies, today announced FDA 510(k) clearance has been granted for the company's next generation Macular Integrity Assessment (MAIA).

MAIA offers the latest advances in scanning laser ophthalmoscopy (SLO) confocal microperimetry. Microperimetry is a technology that allows concurrent analysis of structural and functional aspects of the retina. It is a powerful tool that is able to detect, describe, and follow-up pathologies affecting the macular area, including those that represent the leading causes of blindness. MAIA 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.

Microperimetry, with its combined structure-function analysis, represents in clinical practice an essential tool for:

• Deriving the correct diagnostic decision on a variety of retinal diseases
• Monitoring progression of retinal pathologies
• Monitoring treatment efficacy
• Assessing macular function prior to cataract surgery
• Describing fixation characteristics prior to laser treatment
• Examining patients with unexplained vision loss

The additional functions and improved features of the newly enhanced version of the MAIA yield faster examinations. The differences between the redesigned MAIA and its predecessor include:

• External redesign which is more ergonomic and features a smaller footprint
• A more powerful PC
• New automatic alignment
• Dynamic multifixation

CenterVue, Inc. CEO Cliff Wright, OD, states, "FDA clearance of the MAIA represents significant opportunity for eye care professionals. Through the device's combined structure-function analysis, this device is an essential tool for a variety of retinal diseases. From diagnosis, to monitoring progression of both retinal pathologies, and treatment efficacy, the MAIA is the first easy-to-use Microperimetry and represents a significant advance in macular functional analysis."