Avicenna.AI obtains EU-MDR certification for five AI tools

Avicenna.AI, a medical imaging firm, has obtained Medical Device Regulation (MDR) certification for five AI algorithms used to screen severe conditions, certified as Class IIb medical devices by BSI Medical Devices. These include algorithms for intracranial hemorrhage (CINA-ICH), large vessel occlusion (CINA-LVO), stroke severity quantification (CINA-ASPECTS), aortic dissection (CINA-AD), pulmonary embolism (CINA-PE), and opportunistic cases of pulmonary embolism (CINA-iPE).

The EU's new MDR regulations, effective from 2020 with transition periods until 2027 and 2028 for high, medium, and low-risk devices, impose stringent requirements impacting early device development opportunities, noted by industry leaders.

Founded in 2018 in France, Avicenna.AI secured three US FDA clearances this year. Notably, CINA-VCF gained FDA clearance for triaging and detecting vertebral compression fractures (VCFs) in CT scans. In March 2024, FDA approvals were granted for CINA-iPE and CINA-ASPECTS following a $10 million Series A funding round supported by Innovacom and CEMAG Invest.