Avicenna.AI’s Medical Imaging Portfolio Secures European MDR Certification

July 3, 2024—Avicenna.AI, a France-based medical imaging artificial intelligence (AI) company, announced it has received the Medical Device Regulation (MDR) certificate for five of its algorithms from certification body BSI Medical Devices. The company advised that with this certification, its product portfolio is fully compliant with the European Union’s MDR 2017/745.

Avicenna.AI stated that its products have been certified as class IIb medical devices, which requires a high level of clinical validation. The certified products include the company’s suite of AI tools for neurovascular conditions, as well as its suite of algorithms for vascular conditions.

The company’s MDR-certified AI tools include algorithms for intracranial hemorrhage (CINA-ICH), large vessel occlusion (CINA-LVO), quantification of stroke severity (CINA-ASPECTS), aortic dissection (CINA-AD), pulmonary embolism (CINA-PE), and opportunistic cases of pulmonary embolism (CINA-iPE). All the products have received CE Mark approval in Europe and FDA clearance in the United States, noted the company.

The MDR emphasizes clinical evaluation, postmarket surveillance, device traceability, rigorous technical documentation, and risk management to enhance patient safety and ensure high standards for medical devices, including AI and software-based solutions, advised Avicenna.AI.