The breakthrough device designation is said to indicate that the FDA intends to offer interactive and timely communication with the sponsor during device development and across the review process for various types of premarket submissions.
The designation represents that Notal’s Home OCT system is an artificial intelligence (AI)-based home use device indicated for automated identification of intra and subretinal fluid in the central 10 degrees of eyes diagnosed with exudative age-related macular degeneration (eAMD).
The device is advised 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.
Notal Vision current chief medical officer and incoming CEO Dr Susan Orr said: “We are very pleased with the FDA’s acceptance of our request for Breakthrough Designation. 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 patient-operated Notal Home OCT is a light-weight device developed for technician-free operation by eAMD patients.
Notal OCT analyzer (NOA), which is a machine-learning algorithm, carries out an automated analysis after completion of test by the patient.
NOA will generate report if retina fluid is detected. Later, it will be conveyed to the treating physician by the Notal Vision diagnostic clinic.
Notal Vision Home OCT will help reduce the time from fluid onset to next treatment through providing retinal specialists with immediate notification if recurrent disease activity is detected.
Notal Vision is planning to commercialize the new OCT system in 2020.
Notal Vision CEO Quinton Oswald 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.”
