Avicenna.AI has received Medical Device Regulation (MDR) certification for five of its algorithms from the British Standards Institution (BSI) Medical Device Division, meaning that the company’s product portfolio is fully compliant with the European Union’s (EU) MDR 2017/745, which is now mandatory for medical device companies that want to offer their solutions in Europe.
According to a press release from Avicenna.AI, the MDR was introduced to update the EU’s medical device regulations to address safety issues and the recent emergence of artificial intelligence (AI) tools and software on medical devices (SaMDs) that did not exist when the old regulations were enacted. Ensuring MDR compliance is a key element in obtaining and maintaining CE mark status, which allows devices to be freely traded in the EU, the press release added.
Compared to the previous Medical Device Directive (MDD), the MDR is broader in scope and has stricter requirements. According to Avicenna.AI, the MDR emphasizes clinical evaluation, post-market surveillance, device traceability, 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’s products have been certified as Class IIb medical devices, which require a high level of clinical validation, and include the company’s suite of AI tools for neurovascular diseases and a suite of algorithms for vascular diseases.
“Achieving MDR certification is an important milestone for Avicenna.AI,” said Stéphane Berger, Regulatory Manager at Avicenna.AI. “It demonstrates our commitment to meeting the highest standards of medical device safety and performance. This certification not only reinforces our commitment to compliance, but also provides our customers with assurance of the quality and reliability of our AI product portfolio.”
The company’s newly 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 cases of pulmonary embolism (CINA-iPE).All of these products are CE marked and cleared by the U.S. Food and Drug Administration (FDA), according to the release.
“Importantly, despite differing SaMD regulatory requirements between U.S. and European authorities, our AI products have consistently received both FDA and CE Mark approval,” Berger added.
Avicenna.AI claims that all of its AI tools are seamlessly integrated into radiologists’ clinical workflow, automatically triggering and reporting the results of its algorithms through the systems clinicians already use.
