Notal Vision Home Optical Coherence Tomography (OCT) System
Notal Vision IncThe Notal Vision Home OCT System is an AI-based home use device that enables patients with neovascular age-related macular degeneration (NV-AMD) to self-image their eyes at home using Optical Coherence Tomography (OCT). It captures detailed images of the retina, segments and quantifies hypo-reflective spaces associated with fluid build-up, and securely transmits data for physician review between scheduled clinic visits. This allows more frequent monitoring of eye disease progression without replacing standard clinical examinations.
Intended 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. Intended for imaging at home between regularly scheduled clinic assessments, not to make treatment decisions or replace standard care examinations.
Technology
The device consists of the Notal Home OCT handheld self-imaging device using Spectral Domain OCT technology, a secured wireless communication system that transmits imaging data to the Notal Health Cloud, and an AI software module (Notal OCT Analyzer, NOA) running in the cloud that processes volume scans by performing segmentation of intraretinal and subretinal hypo-reflective spaces and calculating their volumes. Data are presented to clinicians via an interactive web viewer.
Performance
Clinical performance was evaluated in two pivotal studies enrolling patients with neovascular age-related macular degeneration (NV-AMD). The device demonstrated positive and negative percent agreements for visualization of retinal fluid comparable to in-office OCT systems, with successful patient self-image rates over 85%. Repeatability and reproducibility of volume measurements and AI segmentation agreement with expert graders were reported. Safety data showed no device-related adverse events. Extensive non-clinical testing including bench, optical safety, software validation, and human factors testing confirmed device safety and usability.
Device Timeline
- 1
Submission
6/7/2023
11 months - 2
FDA Approval
5/15/2024
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