Trade Journals & Press

Ocular Surgery News | January 12, 2025

Home OCT Offers Precise Retinal Treatment Personalization with AI

The Ophthalmologist Podcast | January 8, 2025

Revolutionizing Holistic Patient Care: Innovations and Technologies

Straight From the Cutters Mouth | January 6, 2025

January 2025 Retinal Physician Preview with Drs. Safa Rahmani and Sarwar Zahid Including Home OCT, Intraoperative OCT, and Ang-2 Inhibition Discussion

Retinal Physician | January 1, 2025

Understanding Protocol AO, the DRCR Retina Network’s Study of Home OCT

Retinal Physician | Jan/Feb 2025

The Potential Impact of Home OCT on nAMD Management

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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