AI Powered Notal Vision SCANLY_THUMBNAIL

Notal Vision’s AI-Powered Home OCT Gains FDA De Novo Authorization

Notal Vision (Virginia, USA) announced on May 16 that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for the firm’s SCANLY home optical coherence tomography (OCT) device.

The FDA nod makes the AI-powered SCANLY the first patient self-operated optical coherence tomography (OCT) device for monitoring neovascular age-related macular degeneration (nAMD) in the United States.

Home OCT devices like SCANLY aim to meet the significant burden on patients and their caregivers in screening for and monitoring nAMD progression.

“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, CEO of Notal Vision, in a news release. 

SCANLY, designated as a Breakthrough Device by the FDA, captures high-resolution spectral-domain OCT images of a 10 by 10-degree area centered on the point of fixation. The device’s artificial intelligence (AI), known as the Notal OCT Analyzer (NOA), segments and estimates the volume of hypo-reflective spaces (HRS), key biomarkers in managing nAMD, on OCT images.

Device aims to ease disease burden

AMD is a leading cause of blindness among older adults and necessitates frequent clinic visits for monitoring. This poses a significant challenge, particularly for underserved and elderly populations.

Self-directed home OCT devices like the newly authorized SCANLY address this issue by allowing patients to perform retinal imaging at home, offering a new level of convenience and potentially improving adherence to monitoring protocols. 

Ophthalmologists can now prescribe the SCANLY Home OCT Monitoring Program, enabling them to remotely access detailed OCT images and AI-driven analyses between regular office visits. This program aims to provide greater disease insights and enhance personalized patient care.  

Clinical trial evidence key to De Novo authorization

Two U.S. trials with over 500 patients demonstrated SCANLY’s safety and efficacy in visualizing intra- and subretinal hypo-reflective spaces. Ninety-seven percent (97%) of participants, with a mean age of 77, successfully performed home imaging without assistance, completing 5,426 scans with a high adherence rate of 5.9 scans per week. Participants spent a mere 48-second average for each scan.1,2

In Notal Vision’s news release, Dr. Jeffrey S. Heier, Director of the Retinal Service and Retinal Research at Ophthalmic Consultants of Boston, praised the technology. 

“It has been a privilege to participate in several Home OCT clinical trials,” he said. “I was impressed by the overall positive patient experience and their ability to reliably self-image without any assistance or training from our clinic.” 

Once enrolled in the SCANLY Home OCT Monitoring Program, patients receive the device via courier and can begin daily scanning immediately. Images are automatically transmitted to the Notal Health Cloud for analysis, with physicians accessing data and setting eye-specific notifications settings—like volume threshold for total retinal hypo-reflective (TRO spaces—through a HIPAA-compliant portal. 

The physician-led Notal Vision Monitoring Center also supports patients by managing insurance and benefits verification, providing phone support, and sending compliance reminders on behalf of the ophthalmologist’s office. 

Physicians and monitoring centers can utilize established CPT codes (0604T, 0605T, and 0606T) to bill for remote OCT services on a 30-day basis. Notal Vision plans to collaborate with the community and Medicare Administrative Contractors to secure coverage and payment for these remote OCT billing codes.

With the FDA’s authorization, Notal Vision’s SCANLY is set to enhance the standard of care for AMD patients, offering unprecedented remote monitoring capabilities. “This SCANLY Home OCT FDA authorization greatly advances our mission of enabling physicians to preserve patients’ functional vision,” said Guy Katsav, Notal Vision’s chairman. “The personalized care offered by SCANLY will allow our patients to maintain their independence.”

References

  1. Notal Vision Inc. The evaluation of the agreement between the NVHO in the automatic fluid quantification and Cirrus OCT. 2023. Identifier NCT05202587. Available at: https://clinicaltrials.gov/study/NCT05202587. Accessed on May 17, 2024.
  2. Notal Vision Inc. Home OCT fluid visualization agreement study. 2022. Identifier NCT04907409. Available at: https://clinicaltrials.gov/study/NCT04907409. Accessed on May 17, 2024. 
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