FDA Grants De Novo Marketing Authorization For At-Home Retinal Imaging Device

Notal Vision, a Virginia-based patient-centric ophthalmic remote monitoring services provider, has won de novo marketing authorization from the US FDA for a product that allows patients to keep tabs on their age-related macular degeneration while at home.

MACULAR DEGENERATION
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The US Food and Drug Administration announced on May 16 it has granted digital health care provider Notal Vision’s de novo marketing authorization for its patient self-operated Scanly Home optical coherence tomography device for monitoring age-related macular degeneration.

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