Ophthalmic diagnostic services company Notal Vision said it has won breakthrough device designation for its artificial-intelligence-aided macular degeneration diagnostic device.
Privately-held Notal (Manassas, Va.) said its home-based optical coherence tomography (OCT) system was designed to automatically identify 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 company said.
Once a patient completes the test, a proprietary machine-learning algorithm, the Notal OCT analyzer, performs an automated analysis. If retina fluid is detected, the analyzer generates a report, which the company’s diagnostic clinic sends to the treating physician. The goal is to provide retinal specialists with immediate notification of recurrent symptoms, reducing the time from fluid onset to next treatment.
“We are very pleased with the FDA’s acceptance of our request for breakthrough designation,” said Susan Orr, MD, chief medical officer and incoming CEO at Notal Vision, in a statement. “We are eager to work closely with them to bring home-OCT testing to patients with exudative AMD, leveraging leading-edge technology to the benefit of patients, caregivers, and eye care providers alike.”
The company described Notal Home OCT as a patient-friendly, light-weight device designed for technician-free operation by eAMD patients.
“The FDA’s Breakthrough Devices Program is designed to help expedite patient access to novel technologies through intensive interaction and guidance,” said Quinton Oswald, Notal Vision’s current CEO. “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.
