Avicenna.AI Algorithms Pass EU Medical Devices Regulations
The French AI-enabled medical imaging company Avicenna.AI has been granted Medical Device Regulation (MDR) certification for five of its AI tools, confirming that they meet European Union's medical device regulations (MDR 2017/745).
Avicenna.AI's new medical devices include AI algorithms for the detection of 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). These AI technologies can be integrated into the clinic to report results via the systems already used by radiologists.
Avicenna.AI's products have been approved as Class IIb medical devices, indicating a high level of clinical validation. The certified products include the company's AI tools for neurovascular diseases and its vascular algorithms.
The assessment that Avicenna.AI's devices are compliant with MDR 2017/745 now means that the company can commercialise their products in the EU. MDR 2017/745 replaced previous legislation from the European Parliament (93/42/EEC and 90/385/EEC) in 2017, it concerns medical devices and establishes modern safety standards since the advent of AI tools and software as medical devices.
British standards and regulatory body BSI Medical Devices authenticated Avicenna.AI's as being EU compliant. This authentication is essential to acquiring and keeping the EU's CE-mark which allows the device's commercialisation and free trade within the area.
Stéphane Berger, the Regulatory Manager at Avicenna.AI, commented: “Obtaining MDR certification is a significant milestone for 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.”
This EU certification is the next step for Avicenna.AI who have already sought approval from the US regulatory authorities, Berger said: “Crucially, despite the differences in SaMD [(software as a medical device)] regulatory requirements between authorities in the US and Europe, we are consistently achieving both FDA and CE mark clearance for our AI products.”
