Monday, July 15, 2024

Imaging Products from Avicenna.AI Achieve EU MDR Certification, Expanding Regulatory Success

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Imaging products from Avicenna.AI have achieved a significant milestone in the healthcare industry, with five of their algorithms receiving the necessary certifications to fully comply with the European Union’s (EU) Medical Device Regulation (MDR) 2017/745. This achievement ensures that these algorithms are now eligible for distribution and use by customers throughout the EU. The certifications were provided by BSI Medical Devices, a recognized and reputable certifying body.

In a recent press release, Stephane Berger, Avicenna’s regulatory manager, expressed the importance of this achievement. “Obtaining Medical Device Regulation 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 artificial intelligence (AI) product portfolio,” Berger stated. He emphasized that despite the differing regulatory requirements for software as a medical device (SaMD) between the US and Europe, Avicenna.AI has consistently achieved both the Food and Drug Administration (FDA) and CE mark clearance for its AI products. This consistency reflects the company’s dedication to maintaining high standards across different regulatory environments.

Avicenna.AI Secures FDA Clearances for Imaging Solutions, Highlighting Early Detection and Patient Care

This announcement follows a series of regulatory achievements by Avicenna.AI. In June, the company revealed that the FDA had granted 510(k) clearance for CINA-VCF, an AI tool designed to detect unsuspected vertebral compression fractures during CT scans. These fractures are often associated with osteoporosis, a condition that affects millions globally, particularly postmenopausal women.

In the press release announcing the FDA clearance, Avicenna CEO and co-founder Cyril Di Grandi highlighted the significance of early detection. “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,” said Di Grandi.

Earlier in March, Avicenna.AI also announced FDA clearance for two other AI solutions: one for detecting incidental pulmonary embolism during CT scans and another that assists physicians with ASPECT scoring on CT scans. The company’s CEO, Cyril Di Grandi, expressed pride in these achievements, saying, “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.”

Imaging Product

FDA Clearance for Avicenna.AI’s CINA-ASPECTS Validates AI Imaging Solutions

Stephane Berger further highlighted the importance of these clearances, particularly the introduction of CINA-ASPECTS to the US market. “We are delighted to launch CINA-ASPECTS to the US market, marking a significant milestone as our first CADx product receives FDA clearance. 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,” Berger stated.

Yasmina Chaibi, Avicenna’s clinical affairs manager, also commented on the rigorous validation process the company’s AI tools undergo. “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,” Chaibi explained.

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These certifications and regulatory clearances not only signify the technical and clinical robustness of Avicenna.AI’s products but also underscore the company’s dedication to improving patient outcomes through innovative AI solutions. The company continues to push the boundaries of AI in healthcare, ensuring its products meet the highest standards of safety and efficacy in multiple regulatory landscapes. As Avicenna.AI expands its footprint in both the EU and US markets, these achievements pave the way for broader adoption and integration of AI technologies in medical practice, ultimately enhancing the quality of care provided to patients worldwide.

 

Resource: PR Newswire, July 03, 2024

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