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EyeWire News | May 22, 2024

Notal Vision's SCANLY Home OCT Authorized by FDA

Ocular Surgery News | May 17, 2024

FDA grants de novo authorization to AI-powered Scanly Home OCT device

Optometry Times | May 17, 2024

Patient self-operated OCT device receives FDA De Novo authorization

Eyewire News | May 16, 2024

FDA Grants Notal Vision Home OCT System De Novo Marketing Authorization

Retinal Physician | March 1, 2024

Cost Effectiveness of Early Detection of Wet Age-related Macular Degeneration

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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