French AI company achieves key EU regulatory compliance for
multiple algorithms that identify, detect, and quantify severe
conditions from medical images.
LA CIOTAT, France, July 3, 2024 /PRNewswire/ -- Avicenna.AI, a
leading medical imaging AI company, has received Medical Device
Regulation (MDR) certificate for five of its algorithms from
certification body BSI Medical Devices. This development means the
company's product portfolio is fully compliant with the European
Union's MDR 2017/745, which is now mandatory for medical device
companies that want to provide their solutions in Europe.
The MDR was introduced to update the EU's regulations for
medical devices, addressing safety issues and the recent emergence
of 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, which allows a device to be freely traded in the
EU.
Compared to the previous Medical Device Directive (MDD), the MDR
has a wider scope and more stringent requirements. It emphasizes
clinical evaluation, post-market surveillance, device traceability,
rigorous technical documentation, and risk management. 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 requires 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 MDR-certified AI tools include algorithms for
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). All the
products are also CE-marked and FDA-cleared.
"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," added Berger.
All of Avicenna.AI's AI tools are seamlessly integrated into
radiologists' clinical workflow, automatically triggering and
reporting algorithm results through the systems already used by
radiologists.
About Avicenna.AI
Founded in 2018, Avicenna.AI
specializes in providing healthcare AI solutions that utilize deep
learning to identify, detect, and quantify severe pathologies from
CT medical images. Co-founded by Cyril Di
Grandi, a successful entrepreneur who previously co-founded
Olea Medical, and Dr. Peter Chang,
an internationally recognized radiologist, and an expert in AI and
deep learning, Avicenna.AI aims to accelerate therapeutic
decision-making processes and enhance patient outcomes through its
AI-based radiology solutions. For additional details, stay
connected with us on social media and explore Avicenna.AI's website
at www.avicenna.ai.
For more information, contact:
Stéphanie Bellavia,
Marketing Manager, Avicenna.AI
Email: stephanie.bellavia@avicenna.ai
View original
content:https://www.prnewswire.co.uk/news-releases/avicennaai-secures-mdr-certification-for-medical-imaging-ai-portfolio-302188932.html