Avicenna.AI Receives MDR Certification for Medical Imaging AI Portfolio

Friday, July 05, 2024

Avicenna.AI, a leading medical imaging AI company, has recently received certification under the Medical Device Regulation (MDR) for five of its algorithms from BSI Medical Devices, a recognized certification body.

This certification ensures full compliance with the European Union's MDR 2017/745, which is mandatory for medical device companies seeking to market their products in Europe.

The MDR was introduced to update EU regulations for medical devices, specifically addressing safety concerns and adapting to advancements in AI tools and software designated as medical devices (SaMD).

Compliance with MDR is essential for obtaining and maintaining CE-mark status, enabling products to be freely traded in the EU.

Compared to the previous Medical Device Directive (MDD), the MDR imposes stricter requirements and has a broader scope.

It emphasizes clinical evaluation, post-market surveillance, device traceability, comprehensive technical documentation, and rigorous risk management.

These measures are designed to enhance patient safety and uphold high standards for medical devices, including AI and software-based solutions.

Avicenna.AI's certified products are classified as Class IIb medical devices, requiring rigorous clinical validation. These include AI tools for neurovascular and vascular conditions.

Regulatory Manager at Avicenna.AI, emphasized the significance of the MDR certification.

"This certification is a major milestone for Avicenna.AI, demonstrating our commitment to meeting the highest standards of medical device safety and performance. It underscores our dedication to compliance and assures our customers of the quality and reliability of our AI product portfolio."

The certified AI tools from Avicenna.AI cover various conditions such as intracranial hemorrhage (CINA-ICH), large vessel occlusion (CINA-LVO), stroke severity quantification (CINA-ASPECTS), aortic dissection (CINA-AD), pulmonary embolism (CINA-PE), and opportunistic cases of pulmonary embolism (CINA-iPE).

All these products are also CE-marked and FDA-cleared.

"Despite differing regulatory requirements for SaMD between the US and EU, we consistently achieve both FDA clearance and CE mark approval for our AI products."

Avicenna.AI's AI tools seamlessly integrate into radiologists' clinical workflows, automatically initiating and reporting algorithm results through existing radiology systems.






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