France-based medical imaging AI company Avicenna.AI has received the European Union (EU) Medical Device Regulation (MDR) certificate for five of its AI-powered imaging algorithms.
The certification was granted by BSI Medical Devices, an EU Notified Body that provides quality management reviews and CE certifications for medical device manufacturers around the world.
With the MDR certification, the company’s product portfolio becomes fully compliant with the EU MDR 2017/745 regulation, which is now mandatory for medical device companies in Europe.
The MDR-certified AI tools include algorithms for intracranial haemorrhage (CINA-ICH), large vessel occlusion (CINA-LVO), and quantification of stroke severity (CINA-ASPECTS).
The portfolio also includes algorithms for aortic dissection (CINA-AD), pulmonary embolism (CINA-PE), and opportunistic cases of pulmonary embolism (CINA-iPE).
The algorithms use medical images to identify, detect, and quantify severe conditions from medical images.
Avicenna.AI regulatory manager Stéphane Berger said: “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.
“Crucially, despite the differences in SaMD regulatory requirements between authorities in the US and Europe, we are consistently achieving both FDA and CE mark clearance for our AI products.”
Avicenna.AI said that its AI tools have been certified as Class IIb medical devices, which requires a high level of clinical validation.
The certified products include its suite of AI tools for neurovascular conditions, along with its suite of algorithms for vascular conditions.
All its AI tools can be easily integrated into radiologists’ clinical workflow, which automatically triggers and reports results through the existing systems, said medical imaging AI company.
MDR repeals Directive 93/42/EEC, the EU’s regulations for medical devices, to address safety issues and the recent emergence of AI tools and software as a medical device (SaMD).
Compliance with MDR regulation is crucial for obtaining and maintaining CE-mark status, which allows a device to be freely traded in the EU, said the medical AI company.
