The FDA has granted breakthrough device designation to Notal Vision’s home-based OCT system, according to a press release.
The artificial intelligence-based Home OCT System is designed to identify intraretinal and/or subretinal fluid in the central 10° of eyes diagnosed with exudative age-related macular degeneration, the release said. It allows patients to complete the test at home while the machine-learning algorithm Notal OCT Analyzer performs an automated analysis, generates a report and transmits the information to a physician.
“The FDA’s Breakthrough Devices Program is designed to help expedite patient access to novel technologies through intensive interaction and guidance,” Notal Vision CEO Quinton Oswald said in the release. “This designation validates and reaffirms our belief that home-based OCT addresses a high unmet need for clinicians and their patients.”
The company expects to bring the system to the market in 2020.