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FDA grants Altris IMS platform 510(k) clearance

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4 min read

Altris Inc. has received 510(k) clearance from the FDA for the Altris Imaging Management System (IMS), an image and data management platform powered by artificial intelligence (AI) and used in conjunction with optical coherence tomography (OCT).

Give me a refresh on this company.

Incorporated in 2018 and headquartered in Chicago, Illinois, Altris is a medical technology company focused on supporting eyecare professionals (ECPs) in OCT interpretation via AI, leveraging both advanced machine learning and computer vision algorithms.

To note, the company has also developed a mobile application for OCT education interpretation: Altris Education OCT.

Talk about its technology.

The company has developed AI models geared toward offering detection and visualization capabilities for 70+ retinal 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)

What makes these unique?

The CE-certified AI models enable vendor-neutral retina layers segmentation, working with all OCT equipment manufacturers, and provides an, “advanced comparison functionality for automatic AI pathology progression tracking that allows to quantify precisely the changes and pathology dynamics,” according to the company.

Per Altris, the company is planning to submit these models to the FDA for review in early 2024.

If approved, the models will be integrated into the Altris platform for automated OCT scan analysis.

Now this platform.

The Altris IMS platform is a cloud- and AI-based platform designed as a clinical decision support system to store, organize, and support an in-depth analyses of OCT scans.

The platform is intended to segment the retina into 10 layers and calculate retina thickness maps, detect over 100 retinal conditions, calculate different areas and volumes, and support different quantitative follow-up exams for any detected biomarkers, according to the Altris.

Talk about its features.

Per the company, included among the platform’s offerings are the following:

  • Manual annotations and device agnostic measurements
  • Comparison feature (to monitor the pathological state and change over time)
  • Both eyes for examination (for comparison at different time intervals_
  • Progression feature (enabling tracking of a patient’s pathology progression via multiple examinations of the same eye)
  • Creation of OCT analysis reports

How long does it take to generate a report?

According to Altris, 1 minute.

What kind of file format is best used with it?

Altris recommends ECPs use the DICOM format in order to extract the maximum amount of information from the scans; however, the system works with all data formats (jpg, bmp, tiff, png).

Can I integrate it with my EHR system?

Yes! The platform can be integrated with your practice’s electronic health record (EHR) system (in addition to being accessed via the web).

How can I access the system?

Altris IMS is a web-based application, accessible via web browsers.

To note, it is not compatible with smartphones.

Where can I register to use it?

Click here to register and try a free trial.

*Featured image courtesy and property of Altris, Inc.