iHealthScreen completed a prospective study for early diagnosis of AMD in primary care settings. The initial clinical trial results show adequate accuracy for FDA clearance, according to a company news release. The study was funded by NIH SBIR grants and completed with the collaboration of the New York Eye and Ear Infirmary at Mount Sinai.

AMD cases in the U.S. are expected to grow from 2.1 million to 5.4 million in the next 10 years, and there is an increasing need for large-scale screening and identification of individuals who are at risk of developing late AMD. iHealthScreen’s AI-based tool can facilitate this screening and help prevention of late AMD.

“We are encouraged by the results and believe that the new AI-based technology can diagnose early AMD in primary care settings, which enables the timely preventative measures by ophthalmologists and prevent this deterioration of vision," Alauddin Bhuiyan, PhD, CEO of iHealthScreen, said in a company news release. "We want to express our sincerest thanks to the participants and professional staff who were involved in this clinical trial and gathered the data.”

iHealthScreen said it is in the final stage of submitting the results to FDA for 510(k) clearance.