Notal Vision Receives FDA Breakthrough Device Designation for OCT System

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MANASSAS, Va.— The U.S. Food and Drug Administration (FDA) granted "breakthrough device” designation to Notal Vision’s home-based Optical Coherence Tomography (OCT) System, according to an announcement from Notal. The privately-held ophthalmic diagnostic services company focuses on extending ophthalmic disease management from the clinic to the home. The FDA’s device program was established in 2016 to helps patients with diagnosis of life-threatening diseases gain timely access to breakthrough technologies. This designation indicates that the FDA intends to provide interactive communication with the sponsor during device development and throughout the review process for various types of premarket submissions.

Quinton Oswald, CEO of Notal Vision said, "The FDA's Breakthrough Devices Program is designed to help expedite patient access to novel technologies through intensive interaction and guidance. This designation validates and reaffirms our belief that home-based OCT addresses a high unmet need for clinicians and their patients. We are excited about the FDA's recognition of the potential clinical benefit to the over one million Americans living with exudative AMD."

Notal issued an indication for use statement saying Notal's Home OCT System is, "an Artificial Intelligence (AI)-based home use device indicated for automated identification of intra- and/or subretinal fluid in the central 10 degrees of eyes diagnosed with exudative age-related macular degeneration (eAMD). The Notal Home OCT device is intended for testing at home between regularly scheduled clinic assessments and not intended to replace standard-of-care regularly scheduled examinations and clinical testing by an ophthalmic retinal specialist."

The Notal Home OCT is a patient-friendly lightweight device designed for technician-free operation by eAMD patients from the comfort of their home. Once a patient completes the test, a proprietary machine-learning algorithm, the Notal OCT Analyzer (NOA), performs an automated analysis. If retina fluid is detected, a report is generated by NOA which is then conveyed to the treating physician by the Notal Vision Diagnostic Clinic. The Notal Vision Home OCT will complement current disease monitoring strategies by providing retinal specialists with immediate notification if recurrent disease activity is detected, thereby reducing the time from fluid onset to next treatment. Notal Vision anticipates bringing the Notal Vision Home OCT System to the market in 2020.