Avicenna.AI Secures MDR Certification for Medical Imaging AI Portfolio

A French AI company has achieved key EU regulatory compliance for a range of algorithms that identify, detect and quantify serious medical conditions from medical images.

Avicenna.AI, a leading AI medical imaging company, has received Medical Device Regulation (MDR) certification for five of its algorithms from BSI Medical Devices certification body. This development means that the company’s product portfolio is fully compliant with the EU MDR 2017/745, which is now mandatory for medical device companies that want to deliver their solutions in Europe.

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The MDR was introduced to update EU medical device regulations, addressing safety concerns and the recent emergence of AI tools and software as medical devices (SaMDs) 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 a device to circulate freely in the EU.

Compared to the previous Medical Device Directive (MDD), the MDR has a broader scope and more stringent requirements. It emphasizes clinical evaluation, post-market surveillance, traceability of devices, rigorous technical documentation and risk management. 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 requires 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 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.”

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The company’s 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 products are also CE marked and FDA cleared.

“Most importantly, despite differences in SaMD regulatory requirements between U.S. and Europe“We consistently achieve both FDA and CE certification for our AI products,” Berger added.

All Avicenna.AI AI tools are seamlessly integrated into radiologists’ workflows, automatically running and reporting algorithm results through the systems radiologists already use.

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