
The FDA granted de novo marketing authorization to Notal Vision for the patient self-operated AI-powered Scanly Home OCT device, according to a press release.
Scanly, which captures spectral-domain OCT images in a 10° by 10° area centered on the point of fixation and estimates the volume of hyporeflective spaces, was designated as a breakthrough device for patients with neovascular age-related macular degeneration. It is designed to provide ophthalmologists with “remote access to high-resolution OCT images and [Notal OCT Analyzer] image analysis between patients’ regularly