Notal Vision announced that the FDA has granted de novo authorization for its patient-operated Scanly Home OCT device. De novo classification essentially designates Scanly as a breakthrough device and gives Notal approval to market it. Scanly captures spectral-domain OCT images in a 10x10-degree area centered on the point of fixation, and it operates in conjunction with the Notal OCT Analyzer (NOA), an AI-based program that segments and estimates the volume of hyporeflective spaces on OCT images. Ophthalmologists will be able to prescribe the Scanly Home OCT Monitoring Program, provided by the Notal Vision Monitoring Center, for remote access to high-resolution OCT images and NOA image analysis between patients’ regularly scheduled office visits. 

“I am eager to have this game-changing technology available for our patients,” Jeffrey S. Heier, MD, director of the retinal service and retinal research at Ophthalmic Consultants of Boston, said in a news release.