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The Medical Device Regulation (MDR) is a comprehensive set of regulations introduced by the European Union to ensure the safety, efficacy, and quality of medical devices. These regulations have replaced the previous Medical Device Directive (MDD), bringing stricter oversight, enhanced transparency, and more rigorous clinical evaluation requirements. Our AI tools, now certified by BSI as Class IIb medical devices, reflect a high level of clinical validation and compliance with the European Union’s MDR 2017/745.
For manufacturers, especially those developing AI-powered solutions, MDR compliance is not just a legal obligation but a critical component in building trust with healthcare providers and patients. It ensures that AI-driven medical devices meet the highest standards of safety and performance, which is vital in a field where precision and reliability can directly impact patient outcomes.
“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.”
— Stéphane Berger, Regulatory Manager, Avicenna.Ai
Founded in June 2018, Avicenna.AI was formed through a collaboration between Cyril Di Grandi, a software and medical device expert and Peter Chang, MD, a radiologist and AI expert.
Avicenna.AI secured its initial capital infusion of $2.7 million through investments from the French companies Innovacom and CEMAG Invest.
Avicenna.AI introduced its first products, CINA-ICH and CINA-LVO, triage tools for stroke detection. Both solutions obtained the CE-marking in March, swiftly followed by FDA clearance in June.
Avicenna.AI introduced CINA-PE and CINA-AD, two solutions designed for Pulmonary Embolism and Aortic Dissection detection. These innovations achieved CE-marking in December.
In May 2021, Avicenna.AI successfully obtained FDA clearance for CINA-PE and CINA-AD, while also launching and securing the CE marking for its new Stroke quantification tool, CINA-ASPECTS.
Avicenna.AI secured a Series A funding round, bringing aggregated investment close to $10 million. The round was backed by existing investors Innovacom and CEMAG Invest.
Avicenna.AI introduced its new Incidental findings Suite, with the launch of CINA-iPE for unsuspected Pulmonary Embolism detection.
Avicenna.AI Secures Two FDA Clearances For Stroke Assessment And Opportunistic Pulmonary Embolism.
Avicenna.AI Secures a new FDA Clearance For Incidental Vertebral Compression fracture Detection.
The characteristics and quality of our products reflect the excellence of our team, and we work with determination and rigour to provide our partners with increasingly efficient solutions.
We use the power of deep learning to create AI solutions. But learning is also fundamental to how we operate as a company, and we continually seek to challenge ourselves and innovate.
Throughout our business, we bring together the experts that can make a difference – from specialists in machine learning and software development to leaders in radiology and clinical practice.
We value sharing and fairness, guiding our product development to provide effective solutions to our customers, while actively prioritizing collaborative teamwork to achieve our common goals.
Innovation drives us to explore new avenues for delivering superior solutions to our customers, making it a central and invigorating challenge within our company as we continually seek to surpass expectations.
The company has built a team of experienced professionals from multiple domains of expertise who believe in the power of new technology to meet today’s clinical needs.