Avicenna.AI, a medical imaging company, has obtained Medical Device Regulation (MDR) certification for five of its AI algorithms used to screen severe conditions. These products have been certified as Class IIb medical devices by BSI Medical Devices. The EU MDR regulations came into effect in 2020, with a transition period until 2027 for high-risk devices. Avicenna.AI also secured three US FDA clearances this year for various AI tools. The company’s regulatory manager emphasized the significance of MDR certification in demonstrating commitment to safety and performance standards. Another company, Medimaps Group, received MDR certification for AI imaging processing software. The use of AI in medical imaging is increasing, with global revenues expected to reach $18.8bn by 2027. In August 2023, the US FDA approved IMIDEX’s VisiRad XR, an AI-powered device for analyzing chest X-rays. The stringent requirements of MDR certification have raised concerns among industry leaders about limiting opportunities for early device development. Overall, the adoption of AI in healthcare, particularly in medical imaging, is on the rise with regulatory certifications playing a crucial role in ensuring safety and quality standards.
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Avicenna.AI obtains EU-MDR certification for five AI tools. #healthcaretech
