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FDA grants clearance to next-generation Macular Integrity Assessment
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CenterVue Inc. announced that the company's next-generation Macular Integrity Assessment received 510(k) clearance from the U.S. Food and Drug Administration.
The Macular Integrity Assessment (MAIA) is designed to provide quicker examinations and features several upgrades, including "external redesign, which is more ergonomic and features a smaller footprint, a more powerful PC, new automatic alignment and dynamic multifixation," according to the press release.
CenterVue Inc., which develops diagnostic systems for ocular pathologies, explained in the release that MAIA measures macular sensitivity, fixation stability and focus of the fixation and also provides infrared retinal imaging. Additionally, the system includes a reference database that allows practitioners to compare results with normal subjects.
"FDA clearance of the MAIA represents significant opportunity for eye care professionals," Cliff Wright, OD, CenterVue CEO, said in the release. "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 retinal pathologies and treatment efficacy, the MAIA is an easy-to-use microperimeter and represents a significant advance in macular functional analysis."