Avicenna.AI, a prominent player in the medical imaging AI sector, has recently achieved a significant regulatory milestone by obtaining the Medical Device Regulation (MDR) certification for five of its advanced AI algorithms. This certification, awarded by BSI Medical Devices, confirms that Avicenna.AI’s product portfolio meets the rigorous standards set by the European Union’s MDR 2017/745, which is essential for market access in Europe.
1. Understanding the MDR and Its Implications
- What is the MDR? The Medical Device Regulation (MDR) was introduced to update the EU’s medical device regulations, addressing both safety concerns and the emergence of AI tools and software as medical devices (SaMD).
- Scope and Requirements: Compared to the previous Medical Device Directive (MDD), the MDR introduces stricter requirements, including enhanced clinical evaluation, comprehensive post-market surveillance, stringent device traceability, detailed technical documentation, and robust risk management.
- Importance of MDR Compliance: Achieving MDR compliance is crucial for obtaining and maintaining CE-mark status, which allows medical devices to be marketed throughout the EU.
2. Avicenna.AI’s Achievements
- Certified Algorithms: Avicenna.AI’s suite of AI tools for neurovascular and vascular conditions has been certified as Class IIb medical devices under the MDR.
- Certified Products: The MDR-certified products 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)
3. The Significance of MDR Certification
- A Milestone Achievement: According to Stéphane Berger, Regulatory Manager at Avicenna.AI, obtaining MDR certification represents a major milestone that underscores the company’s commitment to high standards of medical device safety and performance.
- Customer Assurance: This certification not only reinforces Avicenna.AI’s dedication to compliance but also assures customers of the quality and reliability of its AI solutions.
4. Meeting Both EU and US Regulatory Requirements
- Dual Clearances: Avicenna.AI’s AI tools have achieved both CE-mark clearance for the EU market and FDA approval for the US market, demonstrating the company’s capability to meet diverse regulatory standards across major markets.
- Clinical Workflow Integration: All of Avicenna.AI’s AI tools are designed to seamlessly integrate into radiologists’ clinical workflows, offering automated result reporting through existing systems.
5. Future Outlook and Continued Commitment
- Looking Ahead: Avicenna.AI is focused on further optimizing its AI tools and continuing to provide high-quality solutions that meet regulatory requirements and support clinical needs.
- Future Goals: The company remains committed to advancing its AI technologies and ensuring that its products maintain the highest standards of safety and effectiveness.