RetinAI Medical AG received the U.S. Food and Drug Administration 510(k) clearance of RetinAI Discovery, paving the way for the startup to enter the U.S market. The image and data management platform enables next-level interoperability across the clinical and clinical study ecosystems in ophthalmology.
Since 2017, RetinAI has been developing software solutions to accelerate clinics, research and pharmaceutical workflows globally using advanced machine learning and computer vision. The company builds tools to collect, organise and analyse health data from the eyes, enabling healthcare professionals and companies to make the right decisions sooner.
The CE-mark certified platform, RetinAI Discovery, allows for organising and analysing ophthalmic medical images, such as optical coherence tomography (OCT) scans and fundus photographs from various medical devices. The platform provides secure, on the cloud, web-based access to facilitate collaborative and interactive analysis of clinical cases in real-time.
“Discovery is an advancement in image management platforms for Ophthalmology and is designed to deliver transparency across datasets from different devices. With its intuitive user interface and web-based access, Discovery fosters participative medical management to better serve patients and speed up clinical studies' decision-making. We’ve already seen the benefits of how Discovery streamlines management and analysis in clinical studies and clinics in Europe, and we are excited to bring our innovation to the U.S,” said, Carlos Ciller, CEO of RetinAI.
The U.S. Food and Drug Administration 510(k) clearance for RetinAI Discovery demonstrates that the platform is safe and effective, a key milestone that brings RetinAI a step closer to commercialising the tool in the U.S. market. Last year, Ciller revealed the company plans to establish offices in the U.S. and set up a customer base. This step will build on the startup’s success in Switzerland and across Europe, where it has already onboarded more than 100 customers, including researchers, pharma companies, clinics and hospitals.
Besides the Discovery platform, RetinAI has developed a set of AI models to quantify fluid and layer segments in retinal tissue with expert-level accuracy in vision-threatening conditions such as Age-related Macular Degeneration (AMD), Diabetic Retinopathy (DR), Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO). These AI models are CE-marked and the company is planning an FDA submission in 2022. Once approved, these AI models will be integrated into Discovery® for automated analysis of key disease markers to aid physicians in their clinical decisions.
(Press release/RAN)
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