FDA grants 510(k) clearance to Altris IMS platform for OCT scans
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Altris AI’s IMS platform, which can store and organize OCT scans and supports improved analysis, has received FDA 510(k) clearance, the company announced in a press release.
“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,” Maria Znamenska, MD, PhD, chief medical officer at Altris, said in the 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.”
According to the release, the web-based IMS platform includes manual annotations and device agnostic measurements that allow eye care professionals to visualize retina layers and highlight specific areas of OCT scans. Other features include comparison, progression and smart-reporting capabilities that help practitioners monitor change and progression of disease, as well as create comprehensive OCT analysis reports.
By receiving FDA 510(k) clearance, Altris states that its IMS platform software is safe and effective, bringing it closer to commercialization in the U.S. market. The company is planning the next phase of FDA submission in early 2024.
Editor’s note: On Sept. 21, 2023, this article was corrected to indicate that the news refers to the 510(k) status. Healio regrets the error.
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