RetinAI establishes presence in the US market

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30.09.2022

RetinAI Medical AG, a leader in clinical and imaging data management software and advanced analytics, has launched its first US-based office in Boston. The startup has also achieved 21 CFR Part 11 compliance to support research and clinical studies in the US.

Founded in 2017, RetinAI develops software solutions for experts in ophthalmology to accelerate clinical, research and pharmaceutical workflows globally using advanced machine learning and computer vision. Its CE-marked data management platform (RetinAI Discovery) and models, including AI models for Geographic Atrophy progression prediction, analyse datasets at-scale to gain a deep understanding on biomarker profiles and patient subgroups or outcomes.

Building on its success in Switzerland, the company is now setting foot in the US with an office in Boston. This expansion will support further growth within the U.S. market, building upon existing collaborations with U.S.-based pharmaceutical companies and its partnership with Heidelberg Engineering to distribute RetinAI’s Disease AI Apps for research use in the U.S.

“Our team is delighted about this natural expansion into the U.S.,” said Carlos Ciller, CEO of RetinAI. “Building on our milestones earlier this year of receiving FDA-clearance for RetinAI’s Discovery Platform and HIPAA-compliance, these new achievements for the U.S. market continue to strengthen our position as a valuable partner for pharma and clinical networks to accelerate workflows in clinical studies and research, while generating a greater level of insights on such an important asset as their data.”

The startup has additionally obtained 21 CFR Part 11 compliance, which is necessary for research or clinical studies conducted in the U.S. It also ensures the security and authenticity of electronic data via audit trailing and legally binding electronic signatures. RetinAI’s global clients can therefore be confident that their RetinAI-assisted, research and clinical studies in the U.S. will have validated and 21 CFR Part 11-compliant processes to collect and analyze data.

(Press release/RAN)

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