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The FDA logo on embossed paper. Image credit: ©Araki Illustrations – stock.adobe.com

Altris has advanced AI models to enable vendor-neutral retina layer segmentation as well as detection and visualization of more than 70 retina conditions such as dry and aet age-related macular degeneration, geographic atrophy, diabetic retinopathy, diabetic macular edema and central retinal vein occlusion.

According to Outlook, in the FDA’s recently issued CRL it concluded it could not approve the BLA during this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.