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NorthJersey.com | November 24, 2024

There's a revolution coming in eyecare. This is what to know

AI in Eye Care | November 21, 2024

‘The Patient Will See You Now’ — How AI is Revolutionizing Eye Care and Empowering Patients

MedPage Today | November 21, 2024

Use of Home-Based OCT for Neovascular AMD Could Lead to More Timely Treatment

EyeTube: New Retina Radio | November 7, 2024

AAO '24 Late-Breakers: ELEVATUM Study and Home OCT in Wet AMD

Medscape | November 6, 2024

Age-Related Macular Degeneration Highlights From AAO 2024

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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