CenterVue Receives 501(k) Clearance from FDA for Fixation Training Module

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FREMONT, Calif. and PADOVA, Italy—CenterVue has received 510(k) clearance from the U.S. Food and Drug Administration for fixation training for its MAIA platform, a technology designed to help patients rehabilitate from vision loss using audio feedback. CenterVue said the designation will permit it to initiate clinical trials of the device and to continue development of a technology that may help patients improve vision.

“With the development of fixation training for the MAIA, CenterVue is demonstrating its commitment to the growing number of individuals around the world living with low vision. Studies have shown that the number of patients with decreased vision due to macular disease, glaucoma and diabetes will double in the next 15 years. It will be critically important to ensure that these individuals have the best ability to live fulfilling lives with no trade off in quality of life due to visual compromise,” said William Burnham, OD, CEO of CenterVue.

CenterVue is a privately held company headquartered in Padova, Italy, with a U.S. subsidiary located in Fremont, Calif. The company develops diagnostic systems for the early detection of sight-threatening pathologies, such as diabetic retinopathy and macular degeneration.