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
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