Sam Brusco, Associate Editor05.16.24
Notal Vision, a digital healthcare provider, has obtained U.S. Food and Drug Administration de novo authorization for its patient self-operated Scanly Home OCT (optical coherence tomography) device.
The FDA breakthrough device designated Scanly is intended for those suffering from wet, or neovascular, age-related macular degeneration (nvAMD). It captures spectral-domain OCT images in a ten by ten-degree area that’s centered on the point of fixation. The artificial intelligence (AI)-based Notal OCT Analyzer (NOA) segments and estimates the volume of hypo-reflective spaces (HRS) on OCT images. These are important biomarkers in managing nvAMD, the company said.
After enrolling in the Scanly home monitoring program and getting the device delivered via courier, patients can start setup and begin daily scanning at home. After each session, images are transmitted to the Notal Health Clould for analysis. Physicians can review this data and set eye-specific notification settings, including volume threshold for total retinal hypo-reflective (TRO) spaces and receive notifications through a web portal.
Patients are supported by clinically trained staff at the physician-led Notal Vision Monitoring Center, which has monitored over 44,000 patients since introduction of the ForeseeHome AMD Monitoring Program, a Medicare covered service for monitoring intermediate AMD, in 2016. As the patients’ first point of contact, the monitoring center manages insurance and benefits verification, phone support, and compliance reminders on behalf of the physician’s office.
“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 AI-based analytical biomarkers of their patients eyes between office visits,” said Kester Nahen, Ph.D., CEO of Notal Vision. “We look forward to supporting our referring physicians in navigating their wet AMD patients’ care.”
The FDA breakthrough device designated Scanly is intended for those suffering from wet, or neovascular, age-related macular degeneration (nvAMD). It captures spectral-domain OCT images in a ten by ten-degree area that’s centered on the point of fixation. The artificial intelligence (AI)-based Notal OCT Analyzer (NOA) segments and estimates the volume of hypo-reflective spaces (HRS) on OCT images. These are important biomarkers in managing nvAMD, the company said.
After enrolling in the Scanly home monitoring program and getting the device delivered via courier, patients can start setup and begin daily scanning at home. After each session, images are transmitted to the Notal Health Clould for analysis. Physicians can review this data and set eye-specific notification settings, including volume threshold for total retinal hypo-reflective (TRO) spaces and receive notifications through a web portal.
Patients are supported by clinically trained staff at the physician-led Notal Vision Monitoring Center, which has monitored over 44,000 patients since introduction of the ForeseeHome AMD Monitoring Program, a Medicare covered service for monitoring intermediate AMD, in 2016. As the patients’ first point of contact, the monitoring center manages insurance and benefits verification, phone support, and compliance reminders on behalf of the physician’s office.
“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 AI-based analytical biomarkers of their patients eyes between office visits,” said Kester Nahen, Ph.D., CEO of Notal Vision. “We look forward to supporting our referring physicians in navigating their wet AMD patients’ care.”