The FDA granted De Novo marketing authorization to Notal Vision’s SCANLY Home OCT (optical coherence tomography) device. The patient-operated SCANLY is the first home retinal imaging service to monitor wet, or neovascular, AMD (nvAMD).

The device captures spectral-domain OCT images in a 10 X 10-degree area centered on the point of fixation. The company’s proprietary, AI-based NOTAL OCT Analyzer segments and estimates the volume of hypo-reflective spaces on OCT images.

A longitudinal pivotal study of nvAMD patients with a mean age of 77 years proved the device’s ease of use —  97% of all participants were able to successfully obtain OCT images at home, with self-scans taking 48 seconds, on average.

Ophthalmologists will be able to prescribe the SCANLY Home OCT Monitoring Program for daily use. At the end of each session, images are automatically transmitted via a built-in wireless connection to the Notal Health Cloud for analysis. Patients are supported by clinically trained staff at the physician-led Notal Vision Monitoring Center. Physicians can then review data remotely and set notification criteria, including a volume threshold for total retinal hypo-reflective spaces, and receive notifications through a HIPAA-compliant web portal. The monitoring center also manages insurance and benefits verification, phone support and compliance reminders on behalf of the prescribing physician.