FDA grants de novo authorization to AI-powered Scanly Home OCT device
Click Here to Manage Email Alerts
Key takeaways:
- The device will allow patients with wet age-related macular degeneration to obtain OCT images at home.
- Three CPT codes for remote OCT will allow physicians and the monitoring center to bill every 30 days.
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 scheduled office visits,” the release said.
Scanly demonstrated efficacy and safety to visualize intraretinal and subretinal hyporeflective spaces in two pivotal U.S. trials that included more than 500 patients. In a longitudinal pivotal study, 97% of wet AMD patients successfully obtained OCT images at home. The adherence rate was 5.9 scans per week, and participants performed 5,426 scans in the study eye, with self-imaging taking 48 seconds on average.
Three established, dedicated CPT codes for remote OCT, 0604T, 0605T and 0606T, will allow for physicians and the monitoring center to bill for services every 30 days, according to the release. In addition, Notal will work with Medicare Administrative Contractors to establish coverage and payment for remote OCT billing codes.
“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,” Kester Nahen, PhD, CEO of Notal Vision, said in the release.
Perspective
Back to Top
The brand-new FDA de novo marketing authorization for the Notal Vision Scanly Home OCT platform ushers in the era of remote diagnostics for retina.
Although we have had the Notal Vision ForeseeHome device commercially available to monitor patients with intermediate dry age-related macular degeneration for many years, the advent of a home imaging device for patients with active neovascular AMD is a dramatic shift for our field.
The Home OCT has been in use investigationally in some clinical trials evaluating potentially very durable therapy to neovascular AMD. In addition to a robust pipeline of durable agents, we enjoyed FDA approval of two new injections (faricimab and aflibercept 8 mg) in the past 2 years, which were evaluated in their registration trials for dosing up to 4 months and perhaps beyond. The marketing authorization for the Scanly paves the way for allowing patients to test at home while current and future long-lasting neovascular AMD treatment can be monitored in real time by their retina specialists.
The Scanly Home OCT may offer ophthalmologists the ability to continue to follow their patients’ response to treatment while reducing the burden and cost of care via fewer in-person office visits and OCT scans. Real-world patient access and utility remain to be tested, but the promise of high-quality home imaging may dramatically improve the patient experience while maintaining the high quality of OCT-driven care that our field provides in neovascular AMD.
Read more about
Click Here to Manage Email Alerts