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CenterVue receives 510(k) clearance for redesigned Macular Integrity Assessment
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The U.S. Food and Drug Administration has granted CenterVue 510(k) clearance for its next-generation Macular Integrity Assessment device, according to a company press release.
The Macular Integrity Assessment (MAIA) for scanning laser ophthalmoscopy confocal microperimetry now features a more ergonomic design and smaller footprint, as well as a more powerful PC, according to the release. Additionally, the redesign allows for faster examinations and includes automatic alignment and dynamic multifixation.
“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,” CenterVue CEO Cliff Wright, OD, said in the press release. “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.”