FDA grants 510(k) clearance to Altris IMS platform

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Altris Inc. announced that the FDA has granted 510(k) clearance of its IMS platform, the company’s image, and data management platform.

According to a news release, the 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.

For 5 years, Altris AI has been developing software solutions for OCT interpretation to support eye care professionals in clinical decision-making using advanced machine learning and computer vision algorithms.

The company noted in its news release its IMS platform has several features that boost the OCT examination analysis routine. These include:

• Manual annotations and device agnostic measurements. These features are for eye care 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. Eye care 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. Eye care specialists can add a fellow eye to the current examination to compare both of them at the same time.
• Progression feature. It allows eye care 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.

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.

Moreover, Altris also 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 others.

According to the news release, these AI models are CE-certified and the company is planning the next FDA submission in the beginning of 2024.The company also has developed an advanced comparison functionality for automatic AI pathology progression tracking that allows to quantify precisely the changes and pathology dynamics. Once approval is granted, the company noted the 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 United States.

Maria Znamenska, MD, PhD, associate professor of ophthalmology and chief medical officer of Altris, highlighted the efforts to improve OCT.

“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,” Znamenska said in the news release. “With the Altris AI platform, eye care 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.”