OCT with AI Capabilities Given Clearance by FDA

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An OCT with artificial intelligence capabilities may soon be available to ODs.

Oct. 11, 2023

Altris, Inc., announced that the U.S. Food and Drug Administration (FDA) has provided 510(k) clearance of Altris IMS platform, the company’s image and data management platform.

Altris platform can store, organize and support in-depth analysis of Optical Coherence Tomography (OCT) scans. The platform provides secure, on-the-cloud, web-based access to facilitate more convenient and accurate OCT scan analysis in ophthalmology and optometry.

Since 2018, Altris AI has been developing software solutions for OCT interpretation to support eyecare professionals in clinical decision-making using advanced machine learning and computer vision algorithms.

Altris IMS platform has features designed to improve the OCT examination analysis routine:

• Manual annotations and device agnostic measurements. These features are for eyecare professionals who want to visualize retina layers, highlight areas of interest on the OCT scans, such as retinal pathologies, and measure their length and width as well as area and volume.
• Comparison feature. Eyecare specialists can monitor the state of the pathology and its change over time to compare it to the same eye in different time intervals
• Both eyes feature. Eyecare specialists can add a fellow eye to the current examination to compare both of them at the same time.
• Progression feature. It allows eyecare professionals to track the progression of a patient’s pathology by adding multiple examinations of the same eye to see the pathology progression.
• The smart reporting feature allows the creation of complete OCT analysis reports.

Altris says that the FDA clearance for the Altris IMS platform “demonstrates that the software is safe and effective, a critical milestone that brings Altris AI closer to commercializing its solutions for OCT interpretation and analysis on the U.S. market.”

In addition to the IMS platform, Altris has advanced AI models to enable vendor-neutral retina layers segmentation as well as detection and visualization of more than 70 retina conditions such as Dry and Wet Age-related Macular Degeneration (AMD), Geographic Atrophy (GA), Diabetic Retinopathy (DR), Diabetic Macular Edema (DME), Central Retinal Vein Occlusion (CRVO) and other.

These AI models are CE-certified and the company is planning the next FDA submission in the beginning of 2024. Also, Altris has developed an advanced comparison functionality for automatic AI pathology progression tracking that allows eyecare practitioners to quantify precisely the changes and pathology dynamics. Once approved, these AI solutions will be integrated into the Altris platform for automated OCT scan analysis while now these AI models are available for research purposes in the U.S.

“OCT is one of the best and the most difficult for interpretation ophthalmic imaging methods, that is why we wanted to make it more effective and accurate,” says Maria Znamenska, MD, Ph.D., Associate Professor of Ophthalmology and Chief Medical Officer of Altris AI. “With the Altris AI platform, eyecare specialists are finally equipped with the tool that helps them detect retinal pathologies, pathological signs and biomarkers. It means less human errors, early detection of the pathologies that can lead to blindness, and better patient outcomes as a result.”