Avicenna.AI Receives EU Certification for AI Imaging Products

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Avicenna.AI announced that five of its algorithms have received the appropriate the certifications in order to make them fully compliant with the European Union’s MDR 2017/745, which were created in response to the rise of AI as SaMD. This means that these algorithms are eligible to be provided to customers in the EU. According to Avicenna, BSI Medical Devices provided the necessary certifications.

In a press release, Avicenna’s regulatory manager Stephane Berger said, “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."

Berger continued, “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.”

This is the latest announcement from the company in regard to regulatory clearance for its products. In June, the company announced that FDA had granted 501(k) clearance to to CINA-VCF, an AI tool used to detect unsuspected vertebral compression fractures during CT scans. These sorts of fractures are often connected with osteoporosis.

In a press release issued at the time, Avicenna CEO and co-founder Cyril Di Grandi said, “Osteoporosis is a global burden affecting millions, especially postmenopausal women, and often goes unnoticed until symptoms like pain and loss of mobility appear. By detecting vertebral compression fractures early, we aim to help patients maintain better mobility and independence, enhance the well-being of those at risk, and reduce the burden on healthcare systems worldwide. We have also partnered with the International Osteoporosis Foundation to increase awareness about this debilitating condition."

In March, the company announced FDA clearance for two other AI solutions: one tool that uses AI to detect incidental pulmonary embolism during CT scans, and another that assists physicians with ASPECT scoring on CT scans.

In a press release, Grandi said, “After a long journey of dedication and perseverance, we are thrilled to announce the FDA clearance of not one, but two of our groundbreaking products. The clearance of CINA-iPE and CINA-ASPECTS marks a significant milestone in our mission to strive for excellence in advancing patient care. These achievements stand as a testament to the unwavering commitment of our team."

"We are delighted to launch CINA-ASPECTS to the US market, marking a significant milestone as our first CADx product receives FDA clearance," added Berger. "We take pride in being at the forefront of CADx solutions, being the first AI company supported by thorough clinical validation and a rich repository of real-world clinical data, which ensures compatibility across all manufacturers and platforms."

The company’s clinical affairs manager Yasmina Chaibi also said, “From day one, we have been committed to validating our AI tools on every type of CT scanner. In our validation studies, CINA-iPE achieved excellent sensitivity and specificity, demonstrating its ability to provide effective prioritization and triage on routine CT scans performed for other clinical indications than pulmonary embolism suspicion."

Sources

1. Avicenna.AI Secures MDR Certification for Medical Imaging AI Portfolio. Avicenna.AI. July 3, 2024. https://www.prnewswire.com/news-releases/avicennaai-secures-mdr-certification-for-medical-imaging-ai-portfolio-302188929.html
2. Avicenna.AI Secures FDA Clearance for AI Detection of Vertebral Compression Fractures. Avicenna.AI. June 12, 2024. Accessed July 3, 2024. https://www.prnewswire.com/news-releases/avicennaai-secures-fda-clearance-for-ai-detection-of-vertebral-compression-fractures-302169783.html
3. Avicenna.AI Secures FDA Clearance for Two Healthcare AI Solutions. Avicenna.AI. March 26, 2024. Accessed July 3, 2024. https://www.prnewswire.com/news-releases/avicennaai-secures-fda-clearance-for-two-healthcare-ai-solutions-302099611.html