Patient self-operated OCT device receives FDA De Novo authorization

Image Credit: AdobeStock/Vasyl

Digital healthcare provider Notal Vision announced that its patient self-operated SCANLY Home optical coherence tomography (OCT) device has been grant De Novo authorization through the US FDA. It has been designated by the FDA as a Breakthrough Device for patients with wet, or neovascular, age-related macular degeneration (nAMD).¹

“We are very excited to receive FDA authorization to market SCANLY Home OCT as the first-ever patient self-operated, home-use device that gives physicians remote access to high-resolution, cross-sectional retinal images and [artificial intelligence, or] AI-based analytical biomarkers of their patients’ eyes between office visits,” said Kester Nahen, PhD, CEO of Notal Vision, in a news release. “We look forward to supporting our referring physicians in navigating their wet AMD patients’ care.”

SCANLY works by capturing spectral-domain OCT images in a 10x10-degree area centered on the point of fixation, according to the release. The device’s proprietary, AI-based Notal OCT Analyzer then segments and estimates the volume of hypo-reflective spaces on OCT images. The volume of these spaces provide biomarkers in managing nAMD. The device can be provided to patients through a physician’s prescription of the SCANLY Home OCT Monitoring Program, which is provided by the Notal Vision Monitoring Center. The program allows remote access to high-resolution OCT images and Notal OCT Analyzer image analysis between office visits by transmitting images to the Notal Health Cloud for physician analysis. Physicians will be able to review data, set eye-specific notification criteria, including volume threshold for total retinal hypo-reflective spaces, and receive notificaitons through a HIPAA-compliant web portal.¹

CPT codes for remote OCT will allow physicians and the Notal Vision Monitoring Center to bill for the program’s services every 30 days. Notal will also be working with Medicare administrative contractors to establish coverage and payment for remote OCT billing codes. This is in part of the company’s ForeseeHome AMD Monitoring Program, which monitors more than 44,000 patients with intermediate AMD and is covered by Medicare. The program manages insurance and benefits verification, phone support, and compliance reminders for the physician’s office.¹

“Building on our ForeseeHome patient engagement platform, this SCANLY Home OCT FDA authorization greatly advances our mission of enabling physicians to preserve patient’s functional vision,” said Guy Katsav, Notal Vision’s chairman and managing director at Ganot Capital, in the release. “The personalized patient care offered by the SCANLY Home OCT Monitoring Program, coupled with the early disease detection offered by our Medicare reimbursed ForeseeHome Program, will allow our patients the possibility to maintain their independence and never miss their grandchild’s smile.”

SCANLY’s safety and efficacy in visualizing intra- and subretinal hypo-reflective spaces was determined in 2 pivotal US trials involving over 500 patients. In the longitudinal pivotal study of patients with nAMD, 97% of the patients (mean age of 77 years) were able to successfully obtain OCT images at home. A total of 5,426 scans were performed by patients in the study eye, with an adherence rate of 5.9 scans a week observed in the study. Self-imaging took patients an average of 48 seconds.¹

“It has been a privilege to participate in several home OCT clinical trials,” said Jeffrey S. Heier, MD, director of the retinal service and retinal research at Ophthalmic Consultants of Boston, in the release. “I was impressed by the overall positive patient experience and their ability to reliably self-image without any assistance or training from our clinic. The AI-based image analysis is an added benefit of the imaging technology, as it facilitates monitoring for those practices managing a large number of patients. I am eager to have this game-changing technology available for our patients.”

Reference:

1. FDA grants AI-powered notal vision home OCT “SCANLY” De Novo marketing authorization. News release. Notal Vision. May 16, 2024. Accessed May 16, 2024. https://notalvision.com/assets/press-releases/May-16-2024-FDA-Grants-AI-Powered-Notal-Vision-Home-OCT-22SCANLY22-De-Novo-Marketing-Authorization.pdf