U.S. FDA grants device designation for patient-operated home OCT device

The Notal Home OCT device is intended for testing at home between regularly scheduled clinic assessments.

Ophthalmic diagnostic services Notal Vision (Manassas, VA), which focuses on advancing eye care by extending ophthalmic disease management from the clinic to the home, has received U.S. FDA Breakthrough Device designation for its home-based optical coherence tomography (OCT) system for the agreed-upon indications for use. This designation indicates that the U.S. FDA intends to provide interactive and timely communication with the sponsor during device development and throughout the review process for various types of premarket submissions.

The indication for use statement for the company's Home OCT system conveys that it 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 Home OCT system 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 machine learning algorithm, the Notal OCT Analyzer (NOA), performs an automated analysis. If retina fluid is detected, a report is generated by the NOA, which is then conveyed to the treating physician by the Notal Vision Diagnostic Clinic. The Home OCT system 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.

"The FDA's Breakthrough Devices Program is designed to help expedite patient access to novel technologies through intensive interaction and guidance," says Quinton Oswald, CEO of Notal Vision. "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 Vision anticipates bringing the Home OCT system to the market in 2020.

For more information, please visit www.notalvision.com.

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