Oculocare's Alleye Receives FDA 510(k) Clearance for Monitoring Eyesight in AMD
Tuesday, July 10, 2018 12:18 AM
ZURICH—Swiss technology company Oculocare medical Inc.
announced FDA 510(k) clearance of its Alleye
, a mobile medical software application used to detect and monitor age-related macular degeneration (AMD). Alleye is designed to detect and characterize central and paracentral metamorphopsia (visual distortion) in patients with macular conditions including AMD and diabetic retinopathy. After medical diagnosis by an eye specialist, the mobile application Alleye lets patients regularly perform simple self-tests at home to monitor their eyesight and assess disease progression.
“We are very excited about the FDA clearance which will help millions of patients with AMD to better manage their health by monitoring their eyesight," said Lucas Bachmann, CEO and co-founder of Oculocare. "We are committed to advancing medical software innovations that leverage digital technology to improve patient care. After Europe, we plan to make Alleye available in the U.S. and other countries worldwide thereby enhancing patient health and fully exploiting the potential of our medical mobile platform.”
Oculocare is commercializing Alleye in Europe independently since 2017 and through partnerships with Novartis
. In the U.S. Oculocare is seeking to market Alleye through alliances with a pharmaceutical or medical technology partner.