Avicenna.AI has received Medical Device Regulation (MDR) certification for five of its algorithms from British Standards Institution (BSI) Medical Devices—a development that means 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 wanting to provide solutions in Europe.
As a press release from Avicenna.AI notes, the MDR was introduced to update the EU’s regulations for medical devices, addressing safety issues and the recent emergence of artificial intelligence (AI) tools and software as a medical device (SaMD), which did not exist when the old regulations were created. Ensuring MDR compliance is a critical component of obtaining and maintaining CE-mark status, allowing a device to be freely traded in the EU, the release adds.
Compared to the previous Medical Device Directive (MDD), the MDR has a wider scope and more stringent requirements. It emphasises clinical evaluation, post-market surveillance, device traceability, rigorous technical documentation, and risk management, according to Avicenna.AI. These measures aim to enhance 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. The certified products include the company’s suite of AI tools for neurovascular conditions, as well as its suite of algorithms for vascular conditions.
“Obtaining MDR certification is a significant 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 dedication to compliance but also assures our customers of the quality and reliability of our AI product portfolio.”
The company’s newly MDR-certified AI tools include algorithms for intracranial haemorrhage (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 of these products are CE-marked as well as being US Food and Drug Administration (FDA)-cleared, the release states.
“Crucially, despite the differences in SaMD regulatory requirements between authorities in the USA and Europe, we are consistently achieving both FDA and CE-mark clearance for our AI products,” Berger added.
Avicenna.AI claims that all of its AI tools are seamlessly integrated into radiologists’ clinical workflow, automatically triggering and reporting algorithm results through the systems already used by clinicians.
