Avicenna.AI Secures European MDR Certification for AI Medical Imaging Solutions Portfolio

Avicenna.AI has received Medical Device Regulation (MDR) certification for five of its algorithms from the British Standards Institution (BSI) Medical Devices – meaning that the company’s product offering is fully compliant with the European Union (EU) MDR 2017/745 regulation, which is now mandatory for medical device companies wishing to offer their solutions in Europe.

As the Avicenna.AI press release notes, the MDR was introduced to update EU medical device regulations, addressing safety concerns and the recent emergence of artificial intelligence (AI) medical device (SaMD) tools and software that did not exist when the old regulations were written. Compliance with the MDR is a key element in obtaining and maintaining CE marking status, which allows the device to circulate freely in the EU, the release adds.

Compared to the previous Medical Devices Directive (MDD), the MDR has a broader scope and more stringent requirements. It emphasizes clinical evaluation, post-market surveillance, device traceability, rigorous technical documentation and risk management, according to Avicenna.AI. These measures aim to increase patient safety and ensure high standards for medical devices, including AI- and software-based solutions.

Avicenna.AI products have been certified as Class IIb medical devices, which require a high level of clinical validation. Certified products include the company’s AI toolkit for neurovascular conditions, as well as a set of algorithms for vascular conditions.

“Obtaining MDR certification is a significant milestone for Avicenna.AI,” said Stéphane Berger, Regulatory Affairs Manager at Avicenna.AI. “It is a testament to our commitment to meeting the highest standards of safety and performance for medical devices. This certification not only reinforces our commitment to compliance, but also assures our customers of the quality and reliability of our AI product portfolio.”

The company’s new MDR-certified AI tools 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 pulmonary embolism (CINA-iPE), all of which are CE marked and cleared by the U.S. Food and Drug Administration (FDA), the release said.

“Most importantly, despite differences in SaMD regulatory requirements between U.S. and European authorities, we have consistently achieved both FDA approval and CE Mark for our AI products,” Berger added.

Avicenna.AI ensures that all of their AI tools are seamlessly integrated into radiologists’ workflows, automatically running and reporting algorithm results through the systems clinicians already use.