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May 16, 2024

FDA Grants AI-Powered Notal Vision Home OCT "SCANLY" De Novo Marketing Authorization

February 22, 2023

Clinical trials results demonstrate value of home OCT at international meetings

October 25, 2022

Digital home monitoring shows unique predictive value in disease progression for AMD patients

June 29, 2022

Efficacy of Notal Vision Home OCT demonstrated by a series of scientific and clinical work

April 26, 2022

Retrospective study covering 2,000 patients over 10 years using ForeseeHome AMD remote monitoring shows substantially better outcomes for patients

SCANLY Home OCT FDA Intended Use

SCANLY Home OCT has not been approved by FDA for use other than described in the following Intend Use: The Notal Vision Home Optical Coherence Tomography (OCT) System is an Artificial Intelligence (AI)-based Home Use device indicated for visualization of intraretinal and subretinal hypo-reflective spaces in a 10 by 10-degrees area centered on the point of fixation of eyes diagnosed with neovascular age-related macular degeneration (NV-AMD). In addition, it provides segmentation and an estimation of the volume of hypo-reflective spaces. The Notal Home OCT device is intended for imaging at home between regularly scheduled clinic assessments and not intended to be used to make treatment decisions or replace standard-of care regularly scheduled examinations and clinical testing as needed, including in-office imaging and assessments for changes in vision, by an ophthalmologist.

See also Warnings and Precautions.

ForeseeHome FDA Intended Use

ForeseeHome has not been approved by FDA for use other than described in the following Indication for Use: The ForeseeHome is intended for use in the detection and characterization of central and paracentral metamorphopsia (visual distortion) in patients with age-related macular degeneration as an aid in monitoring progression of disease factors causing metamorphopsia including, but not limited to choroidal neovascularization (CNV). It is intended to be used at home for patients with stable fixation.

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