Notal Vision, a digital healthcare provider, announced in May 2024 that the Food and Drug Administration (FDA) had granted De Novo Marketing authorization to market the patient self-operated SCANLY Home OCT device. The device is the first-ever home retinal imaging service used to keep track of wet AMD (age-related macular degeneration), a leading cause of blindness among older patients. This breakthrough will allow patients affected by wet or neovascular, age-related macular degeneration (nvAMD) to benefit from personalized care. Quinton Oswald is a board member and strategic adviser to the CEO of Notal Vision
Ophthalmologists will recommend the SCANLY Home OCT monitoring program offered by the Notal Vision Monitoring Center to obtain deeper insights into the disease by remotely accessing high-resolution OCT images. In two key US trials which involved over 500 patients, Notal Vision proved SCANLY was a safe and effective technique for visualizing intra- and subretinal hyperreflective spaces. After patients are enrolled into the SCANLY Home OCT Monitoring Program and have obtained the device, they need to finish the setup and begin daily scans from their homes. After scanning, images are transmitted using an inbuilt wireless connection to Notal Health Cloud for analysis.
According to Jeffrey S. Heier, director of retinal service and retinal research at Ophthalmic Consultants of Boston, participating in multiple Home OCT clinical trials yielded positive results, as they allowed patients to successfully self-image without prior training or assistance from clinical staff. Kester Nahen, PhD, CEO of Notal Vision, said the company was excited to receive FDA authorization to market the SCANLY Home OCT imaging device. After the authorization, SCANLY Home OCT will have the capability to support both current and future developments in retinal disease management.
