RetinAI receives FDA Clearance for Discovery, our medical image & data management platform for Ophthalmology
Bern, Switzerland, May 1st, 2022
RetinAI Medical AG (“RetinAI”) today announces U.S. Food and Drug Administration (FDA) 510(k) clearance of RetinAI Discovery®, the company’s image and data management platform for next-level interoperability across the clinical and clinical study ecosystems in Ophthalmology.
The Discovery® platform can be used to organize and analyze ophthalmic medical images, such as optical coherence tomography (OCT) scans and fundus photographs from a variety of medical devices. The platform provides secure, on the cloud, web-based access to facilitate collaborative and interactive analysis of clinical cases in real-time.
Features such as multi-modal imaging compatibility, comparison views of clinical visits, deployment of grading surveys and electronic case report forms (eCRFs) for collecting clinical data are all integrated into the platform. These features were developed to improve workflows and enable the right decisions sooner during treatment and analyses in clinical practice and clinical studies.
In addition to 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.
According to RetinAI’s CEO, Carlos Ciller, PhD, “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 decision making in clinical studies”. Ciller continues, “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.”
RetinAI Medical AG (RetinAI), founded in early 2017, is a Swiss company developing software solutions to accelerate clinics, research and pharmaceutical workflows globally using advanced machine learning and computer vision. The company builds tools to collect, organize and analyze health data from the eyes, enabling healthcare professionals and companies to make the right decisions sooner. RetinAI has developed solutions for data management and analytics for research, clinical studies, patient management and RWE analysis. RetinAI's international team combines clinical, technical, and scientific knowledge to foster innovation for preventive solutions to address severe diseases affecting the eye. www.retinai.com