Avicenna.AI secures MDR certification for medical imaging AI portfolio

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Avicenna.AI, a leading medical imaging AI company, has received Medical Device Regulation (MDR) certificate for five of its algorithms from certification body BSI Medical Devices, marking the company's product portfolio to be fully compliant with the mandatory European Union's MDR 2017/745.

The MDR was introduced to update the EU's regulations for medical devices, addressing safety issues and the recent emergence of AI tools and software as a medical device (SaMD). Avicenna.AI's 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 are also CE-marked and FDA-cleared.

All of Avicenna.AI's AI tools are integrated into radiologists' clinical workflow, automatically triggering and reporting algorithm results through the systems already used by radiologists.