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# SCANLY Home Optical Tomography Device Authorized
- URL: https://www.fdaweb.com/scanly-home-optical-tomography-device-authorized/
- Published: 2024-05-17T12:00:00.000Z
- Updated: 2026-09-14T14:31:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157014

FDA has granted Notal Vision a *de novo* authorization for its patient self-operated SCANLY Home optical coherence tomography (OCT) device. The device was previously designated as a breakthrough device for patients suffering from wet, or neovascular, age-related macular degeneration. It captures spectral-domain OCT images in a 10 by 10-degree area centered on the point of fixation.

The authorization is based on data from two pivotal U.S. trials involving over 500 patients, which demonstrated that SCANLY is a “safe and efficacious way to visualize intra- and subretinal hypo-reflective spaces,” Notal Vision says. The trials found that 97% of all participants were able to successfully obtain OCT images at home, and self-imaging by patients took 48 seconds on average. “At the end of each session, images are automatically transmitted via a built-in wireless connection to the Notal Health Cloud for analysis,” it says. “Physicians can review data, set eye-specific notification criteria, including a volume threshold for total retinal hypo-reflective (TRO) spaces, and receive notifications through a HIPAA-compliant Web portal.”