Clinical co-pilot receives first approval for Class IIb medical device
"Prof. Valmed" was the first company to receive approval from the European Union for its co-pilot of the same name.
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"Prof. Valmed", an AI-supported chatbot for the medical sector, is the first class IIb medical language AI to receive approval. The system uses a large language model to search for specific validated medical sources within a database. Prof. Valmed provides evidence-based answers with corresponding references for medical professionals.
According to the EU Medical Device Regulation (MDR), Class IIb includes products with a medium to high risk. Typical examples are ventilators, infusion pumps and certain implants.
A conformity assessment by a "Notified Body" is mandatory for these products before they can be placed on the market with CE marking.
A notified body is an independent testing organization that has been accredited by national authorities and notified by the EU Commission. These bodies check whether medical devices meet the legal requirements. They carry out audits of manufacturers, evaluate technical documentation and monitor product conformity. In Germany, TĂśV SĂĽd and DEKRA are among the well-known notified bodies for medical devices.
Class IIb AI-based medical devices also fall under the high-risk category of the AI Act, but are still primarily assessed according to MDR requirements.
Experts from the AI Quality & Testing Hub (AIQ) and VDE Health worked closely with the company to develop and approve AI-supported medical devices more quickly. This was explained by Hessian Digital Minister Prof. Dr. Kristina Sinemus and Deputy Chairwoman of the VDE Executive Board Dr. Beate Mand. As a technology partner, AIQ provided appropriate AI development and testing tools and developed the software in compliance with all regulatory requirements , according to the press release.
One focus was on ensuring quality via an "AI quality stack". The experts want to guarantee security as well as transparency and reliability. The aim is to gain the trust of users.
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"The successful certification of Prof. Valmed as a Class IIb medical device impressively demonstrates that innovative AI-based solutions can meet the demanding regulatory requirements in the healthcare sector. As the first AI-supported tool for clinical decision support, Prof. Valmed confirms both the high technical quality of our product and the efficiency and precision of our regulatory support," say Dr. Vera Rödel and Prof. Dr. Heinz Wiendl from Prof. Valmed.
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