AiScreenings

AiScreenings develops digital telemedicine tools specifically designed for dermatology and ophthalmology. Their devices include platforms like the aiVista-DT, which supports remote eye examinations, and the aiSkin-DT, which aids in skin assessments. These tools are engineered to enable healthcare professionals to conduct image-based evaluations and consultations remotely, bridging gaps in specialist care delivery.

AiScreenings is headquartered in France. Since its devices are classified as EU Class I medical devices, they must comply with the EU Medical Device Regulation (MDR) and are registered in the EUDAMED database. This classification applies because these tools are intended for non-invasive diagnostic support and do not pose significant risk to patients.

Yes, AiScreenings’ devices are listed in EUDAMED, the European Union’s medical device registry. This listing is mandatory for all Class I devices under the EU MDR to ensure transparency, traceability, and compliance with regulatory requirements. It allows healthcare professionals, authorities, and patients to verify the device’s legal status and manufacturer details.

AiScreenings’ devices are classified as EU Class I medical devices. This classification is determined by their intended use—non-invasive diagnostic tools for dermatology and ophthalmology—and their minimal risk profile. Class I devices typically involve low-risk procedures or accessories, but they still require compliance with essential safety and performance requirements to ensure patient safety and regulatory adherence.