RetInSight and Heidelberg Engineering partner to implement AI-based geographic atrophy analysis for OCT imaging

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In early November, the EU MDR issued a CE mark certification for RetInSight’s AI-based geographic atrophy monitor

An image showing a 3D rendering of the eye's anatomy. Image credit: ©Axel Kock – stock.adobe.com

The AI-supported algorithm is intended to help identify patients who suffer from geographic atrophy on their first office visit. Image credit: ©Axel Kock – stock.adobe.com

Earlier this month, Austrian company RetInSight announced the launch of its RegInSight GA Monitor, the first medical software solution to use artificial intelligence (AI) for automated analysis of geographic atrophy (GA) images. Now, German company Heidelberg Engineering will partner with RetInSight in deploying that technology. Heidelberg AppWay, the company’s secure platform for ophthalmic apps, will offer access to RetInSight’s AI-based algorithm.1

The GA Monitor is approved under the EU Medical Device Regulation 2017/745 (MDR) as a Class II medical device. According to a press release from RetInSight, the AI-based software visualises and analyses a number of conditions associated with GA, including end-stage lesions with complete loss of retinal pigment epithelium (RPE), as well as the primary and disease-triggering degeneration of the photoreceptors (PR).2 According to the news release, RetInSight’s GA Monitor is the first AI-based algorithm to receive a CE mark approving clinical use.

The AI analysis will work in conjunction with Heidelberg Engineering’s SPECTRALIS optical coherence tomography (OCT) imaging. The AI-supported algorithm is intended to help identify patients who suffer from GA and age-related macular degeneration (AMD) on their first office visit. As patients age, GA becomes more prevalent; the condition affects around 5 million patients globally and accounts for 35% of AMD-related blindness.1

Krysten Williams, head of global marketing and education at Heidelberg Engineering, said there are advanced therapeutics for GA on the horizon which necessitate heightened diagnostic capabilities to ensure patients access treatment. “We are dedicated to supporting confident decision making and efficient workflow in clinical routine,” she said, “First with the exceptional quality of multimodal images from SPECTRALIS and now the secure access to deeper diagnostic insight provided by the RetInSight GA Monitor through HEYEX 2 with Heidelberg AppWay.”

Corinna zur Bonsen-Thomas, CEO of RetInSight GmbH, said the company’s GA Monitor “has the potential to fundamentally change the way ophthalmologists diagnose and treat” patients with the condition.1 RetInSight continues to develop other AI-based software solutions for treatment of other progressive conditions including diabetic macular oedema and retinal vein occlusion.


References

  1. Heidelberg AppWay gives unprecedented access to GA Monitor, the first and only CE-marked AI-based GA-algorithm for clinical use. News release. Heidelberg Engineering. Published November 29, 2023. Accessed November 30, 2023. https://www.heidelbergengineering.com/int/press-releases/heidelberg-appway-gives-unprecedented-access-to-ga-monitor-the-first-and-only-ce-marked-ai-based-ga-algorithm-for-clinical-use/#
  2. RetInSight secures the first MDR CE-certification for its AI-based GA Monitor for the management of geographic atrophy. News release. RetInSight GmbH. Published November 9, 2023. Accessed November 30, 2023. https://retinsight.com/wp-content/uploads/2023/11/retinsight-secures-the-first-mdr-ce-certification-for-its-ai-based-ga-monitor-for-the-management-of-geographic-atrophy/


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