FDA Grants Clearance to Altris IMS for Cutting-Edge OCT Scan Analysis

FDA Grants Clearance to Altris IMS for Cutting-Edge OCT Scan Analysis

September 19, 2023

Altris has received FDA 510(k) clearance for its Altris IMS, the company's image and data management platform. The Altris platform is specifically designed for the storage, organization, and comprehensive analysis of Optical Coherence Tomography (OCT) scans.

This platform offers secure, cloud-based, web-accessible tools to enhance the convenience and precision of OCT scan analysis in the fields of ophthalmology and optometry, as indicated in a company news release.

The Altris IMS platform encompasses several features geared toward enhancing the routine analysis of OCT examinations:

● Manual Annotations and Device-Agnostic Measurements: These features cater to eye care professionals seeking to visualize the layers of the retina, identify areas of interest on OCT scans (such as retinal pathologies), and precisely measure parameters such as length, width, area, and volume.

● Comparison Feature: Eye care specialists can use this functionality to monitor the condition of a pathology and its changes over time, facilitating comparisons with the same eye at different intervals.

● Both Eyes Feature: This feature enables eye care specialists to include a fellow eye in the current examination, allowing simultaneous comparisons between both eyes.

● Progression Feature: Eye care professionals can track the progression of a patient's pathology by incorporating multiple examinations of the same eye, providing valuable insights into the pathology's development over time.

● Smart Reporting Feature: This feature streamlines the creation of comprehensive OCT analysis reports, ensuring efficient and thorough documentation of findings.

Altris' innovative platform promises to significantly enhance the analysis and management of OCT scans, ultimately benefiting the field of eye care and patient outcomes.

“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, Associate Professor of Ophthalmology and Chief Medical Officer of Altris AI, said in a company 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.”

The FDA clearance marks a significant step forward for Altris AI in its journey toward introducing its OCT interpretation and analysis solutions to the US market.

Since 2018, Altris AI has dedicated its efforts to crafting software solutions tailored for OCT interpretation, aimed at supporting eye care professionals in their clinical decision-making process. These solutions leverage advanced machine learning and computer vision algorithms to provide invaluable insights.

In addition to the IMS platform, Altris has developed AI models designed to facilitate vendor-neutral segmentation of retina layers and offer detection and visualization capabilities for over 70 retina conditions, including dry and wet age-related macular degeneration (AMD), geographic atrophy (GA), diabetic retinopathy (DR), diabetic macular edema (DME), central retinal vein occlusion (CRVO), among others. These AI models have received CE certification, and the company's next planned FDA submission is scheduled for early 2024.

Furthermore, Altris has innovated a comparison functionality geared towards automatic AI pathology progression tracking, empowering eye care professionals to precisely quantify changes and pathology dynamics over time. Once approved, these AI solutions will seamlessly integrate into the Altris platform, streamlining and automating OCT scan analysis processes.

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