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