Avicenna.AI secures Medical Device Regulation certification for medical imaging AI portfolio

French AI company achieves key EU regulatory compliance for multiple algorithms that identify, detect, and quantify severe conditions from medical images. 

La Ciotat, FRANCE – July 3, 2024 Avicenna.AI, a leading medical imaging AI company, has received Medical Device Regulation (MDR) certificate for five of its algorithms from certification body BSI Medical Devices. This development means the company’s product portfolio is fully compliant with the European Union’s MDR 2017/745, which is now mandatory for medical device companies that want to provide their solutions in Europe.

The MDR was introduced to update the EU’s regulations for medical devices, addressing safety issues and the recent emergence of AI tools and software as a medical device (SaMD), which did not exist when the old regulations were created. Ensuring MDR compliance is a critical component of obtaining and maintaining CE-mark status, which allows a device to be freely traded in the EU.

Compared to the previous Medical Device Directive (MDD), the MDR has a wider scope and more stringent requirements. It emphasizes clinical evaluation, post-market surveillance, device traceability, rigorous technical documentation, and risk management. These measures aim to enhance patient safety and ensure high standards for medical devices, including AI and software-based solutions.

Avicenna.AI’s products have been certified as Class IIb medical devices, which requires a high level of clinical validation. The certified products include the company’s suite of AI tools for neurovascular conditions, as well as its suite of algorithms for vascular conditions.

“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,” said Stéphane Berger, Regulatory Manager at Avicenna.AI.

The company’s MDR-certified AI tools 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). All the products are also CE-marked and FDA-cleared.

“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,” added Berger.

All of Avicenna.AI’s AI tools are seamlessly integrated into radiologists’ clinical workflow, automatically triggering and reporting algorithm results through the systems already used by radiologists.

Avicenna.AI secures FDA clearance for AI detection of vertebral compression fractures

radiologist explains to a patient about the diagnosis of vertebral compression fracture

Medical imaging AI company receives approval for algorithm enabling opportunistic detection and triage of vertebral compression fractures. 

La Ciotat, FRANCE – June 12, 2024 – Avicenna.AI, a leading medical imaging AI company, has received 510(k) clearance from the US Food and Drug Administration (FDA) for CINA-VCF, a triage and notification AI tool that detects unsuspected vertebral compression fractures (VCFs) in patients undergoing chest or abdomen CT scans.

Often resulting from the deterioration of bone structure (osteoporosis), VCFs can cause significant pain, deformity, and height loss. In the USA, approximately 750,000 adults suffer from osteoporotic VCFs each year, but around two-thirds of those go undetected or unreported. 

The CINA-VCF algorithm identifies and prioritizes vertebral compression fractures detected during routine CT scans for patients undergoing medical imaging for entirely different health conditions, notifying clinicians within seconds. The tool was validated on 474 CT scans (performed for other clinical indications than for VCF evaluation) acquired on 38 different scanner models from four different manufacturers, achieving excellent sensitivity and specificity results.

By facilitating the early detection of vertebral compression fractures, CINA-VCF aims to help prevent further bone density loss and additional fractures, enhancing patient care and outcomes. The tool enables vertebral fractures to be addressed before they multiply, reducing the risk of complications and potentially lowering medical expenses.

“Osteoporosis is a global burden affecting millions, especially postmenopausal women, and often goes unnoticed until symptoms like pain and loss of mobility appear,” said Cyril Di Grandi, co-founder and CEO of Avicenna.AI. “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.”

CINA-VCF is the latest tool from Avicenna.AI to secure FDA clearance, joining its AI solutions for automatic detection of a host of conditions from CT imaging. It is also the company’s second tool FDA-cleared for incidental findings, alongside CINA-iPE, which identifies unsuspected cases of pulmonary embolism in oncology patients.

The company’s other AI tools include algorithms for intracranial hemorrhage (CINA-ICH), large vessel occlusion (CINA-LVO), aortic dissection (CINA-AD), pulmonary embolism (CINA-PE), and quantification of stroke severity (CINA-ASPECTS). All of Avicenna.AI’s AI tools are seamlessly integrated into radiologists’ clinical workflow, automatically triggering and reporting algorithm results through the systems already used by radiologists

Avicenna.AI secures two FDA clearances for Stroke Assessment and opportunistic PE

PR-ASPECTS-FDA-clearance

La Ciotat, FRANCE – March 26, 2024 – Medical imaging AI company Avicenna.AI today announced that it has received 510(k) clearance from the US Food and Drug Administration for its CINA-iPE and CINA-ASPECTS products. Using a combination of deep learning and machine learning technologies, the company develops AI solutions that automatically detect and prioritize life-threatening conditions within seconds, assess them for severity, and seamlessly notify clinicians.

Addressing the serious issue of delayed and missed findings in diagnostic imaging, CINA-iPE is an AI-powered tool that detects incidental pulmonary embolism during routine CT scans. Unsuspected pulmonary embolism is a common finding in routine CT scans of the chest, but as little as 25% of emboli are reported during the initial interpretation. This is particularly relevant in the cancer patient population, where pulmonary embolism is a significant cause of mortality.

The CINA-iPE algorithm identifies lung blood clots detected during routine CT scans for entirely different health conditions. Scan types may include full-body scans, scans of the chest, abdomen, and pelvis, and scans of the thoracic area along with the abdomen and pelvis. The tool was validated on 381 CT scans (performed for other clinical indications than for pulmonary embolism evaluation) acquired on 39 different scanner models from five leading manufacturers, achieving excellent sensitivity and specificity.

“From day one, we have been committed to validating our AI tools on every type of CT scanner,” said Yasmina Chaibi, Clinical Affairs Manager, Avicenna.AI. “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.”

CINA-ASPECTS is an AI tool for stroke severity assessment, automatically processing non-contrast CT scans and calculating the “ASPECT” score, a topographic scoring system used to quantify the severity of a stroke from a CT scan of the brain. The tool computes a heat map indicating the probability of hypodensity and sulcal effacement in the brain, displays a list of infarcted regions, and provides CT images corrected from tilt to easily compare the right and left hemisphere.

In addition to assisting clinicians in the evaluation of the ASPECT score from CT scans, CINA-ASPECTS also helps improve physicians’ reproducibility in ASPECT scoring, which often varies depending on the radiologist reading the scan. The tool was rigorously validated on 200 scans acquired on 27 scanner models from four leading manufacturers.
“The validations and multi-reader-multi-case studies we conducted highlighted that CINA-ASPECTS not only obtained outstanding standalone performance, but also demonstrated that its adjunctive use significantly improved clinicians’ accuracy in the assessment of ASPECTS regions, compared to the conventional use of NCCT images alone,” added Chaibi.

CINA-ASPECTS is the first FDA-cleared tool from Avicenna.AI in the category of computer-aided diagnosis (CADx), which means it goes beyond identifying abnormalities in scans to provide an assessment of the severity of a condition.

PR-ASPECTS-FDA-clearance“We are delighted to launch CINA-ASPECTS to the US market, marking a significant milestone as our first CADx product receives FDA clearance,” said Stéphane Berger, Regulatory and Quality Manager. “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.”

CINA-iPE and CINA-ASPECTS are the latest tools from Avicenna.AI to secure FDA clearance, joining its AI solutions for medical emergencies, including automatic detection of intracranial hemorrhage (CINA-ICH), large vessel occlusion (CINA-LVO), aortic dissection (CINA-AD), pulmonary embolism (CINA-PE) from CT-scan imaging. All of Avicenna.AI’s AI tools are seamlessly integrated into radiologists’ clinical workflow, automatically triggering and reporting algorithm results through the systems already used by radiologists.

“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,” said Cyril Di Grandi, co-founder and CEO of Avicenna.AI. “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.”