Author: Stéphanie BELLAVIA

  • AI triage solution for deadly vascular conditions receives FDA clearance and CE Mark

    AI triage solution for deadly vascular conditions receives FDA clearance and CE Mark

    Avicenna.AI announces the introduction of CINA-PE and CINA-AD, including AI tools for detection and emergency triage of pulmonary embolism and aortic dissection

    Marseille, FRANCE – June 2, 2021 – Medical imaging AI specialist Avicenna.AI today announced that it has received certification in the United States and European Union for CINA-PE and CINA-AD, the new AI solutions that leverages deep learning algorithms for emergency triage of deadly vascular conditions.

    In addition to securing a CE Mark in the EU, CINA-PE and CINA-AD have also received 510(k) clearance from the US Food and Drug Administration for its automatic detection and triage capabilities for both pulmonary embolism (PE) and aortic dissection (AD) from CT-scan imaging.our CINA solution.

    Pulmonary embolism is the blockage of an artery in the lungs and is one of the major causes of death, morbidity, and hospitalization worldwide. It is difficult to diagnose PE as it manifests in diverse ways and can be mimicked by a range of other conditions. CINA CHEST provides rapid automatic PE detection on CT chest angiography, providing clinicians with accurate and rapid real-time alerts on the disease.  

    Aortic dissection is a tear in the inner layer of the aorta, allowing blood to flow between the layers. Although relatively rare, AD has a high mortality rate and is often not diagnosed when it first appears. Patients who receive the appropriate treatment in a timely manner have a high survival rate, so the importance of a quick and accurate diagnosis is critical. CINA CHEST identifies acute AD cases that require urgent intervention, providing accurate, real-time alerts on thoraco-abdominal CT angiography.

    CINA CHEST is part of Avicenna’s CINA family of AI tools that support the treatment of emergencies, including CINA HEAD, its FDA-cleared and CE-Marked solution that supports the detection and triage of stroke and neurovascular emergencies.

    “At Avicenna, we specialize in the development of AI algorithms that can identify acute abnormalities, and CINA CHEST is the latest application we’ve developed to enhance emergency room radiology,” said Cyril Di Grandi, co-founder and CEO of Avicenna.AI. “Our PE and AD triage tools are the third and fourth algorithms we’ve released in less than 12 months, demonstrating our ambition to create AI applications that support detection and triage of emergencies throughout the entire body.”

  • Avicenna.AI receives CE Mark for stroke severity assessment AI tool

    Avicenna.AI receives CE Mark for stroke severity assessment AI tool

    Medical imaging AI innovator secures EU certification for CINA-ASPECTS, which helps quantify the severity of a stroke from a brain CT scan.

    Marseille, FRANCE – May 27, 2021 – Medical imaging AI specialist Avicenna.AI today announced that it has received CE Mark certification for its CINA-ASPECTS AI tool for stroke severity assessment. CINA-ASPECTS automatically processes non-contrast CT scans and calculates the “ASPECT”score, assisting the radiologist within their existing systems and workflow.

    ASPECTS, which stands for “Alberta Stroke Program Early CT Score” is a topographic scoring system used to quantify the severity of a stroke from a CT scan of the brain. It divides the brain territory affected by a stroke into 10 areas of interest and provides a score between zero and 10, where 10 is normal and zero indicates widespread ischemic damage throughout the affected area.

    CINA-ASPECTS computes a heat map indicating the probability of hypodensity and/or sulcal effacement in the brain, and displays a list of infarcted regions. It also provides tilted and resliced CT images to allow easy comparison of the right and left hemispheres.

    In addition to assisting clinicians to evaluate the ASPECT score from CT scans, CINA-ASPECTS also helps improve the reproducibility of the score, which often varies depending on the radiologist reading the scan.

    CINA-ASPECTS is part of Avicenna.AI’s CINA Head family of AI tools that support the treatment of stroke and neurovascular emergencies. CINA Head also includes FDA-cleared and CE-Marked tools for detecting intracranial hemorrhages (ICHs) and large vessel occlusions (LVOs) from CT-scan imaging.

    “CINA-ASPECTS supports stroke physicians and radiologists in the assessment and characterization of early ischemic brain tissue injury using CT image data,” said Cyril Di Grandi, co-founder, and CEO of Avicenna.AI.

    “This new tool demonstrates our commitment to providing radiologists with AI solutions that can enhance their capabilities. Securing a CE Mark is a key milestone and we are delighted to be able to start offering the benefits of CINA-ASPECTS to our European customers – we look forward to FDA clearance in due course.”

  • Dr. Jennifer Soun: Neuroscience to Radiology – Advancing AI in Clinical Practice

    Dr. Jennifer Soun: Neuroscience to Radiology – Advancing AI in Clinical Practice

    Assistant Professor of Radiology at UC Irvine School of Medicine, Jennifer Soun graduated in 2008 in psychology and neuroscience at Princeton University. Dr. Soun is a board-certified UCI Health diagnostic radiologist who specializes in neuroradiology. Her clinical interests include stroke and vascular imaging. She earned her medical degree at Wake Forest School of Medicine in Winston-Salem, NC. She completed a residency in diagnostic radiology at New York Presbyterian-Columbia University Medical Center in New York City, followed by a fellowship in neuroradiology at Massachusetts General Hospital in Boston.  During the ISC (International Stroke Conference) 2020 seminar we had the opportunity to meet and discuss AI in clinical practice. 

    What are the advantages you see in A.I. in your clinical practice? 

    AI in my clinical practice is very helpful and has a lot of potential for different things. One major thing is triaging of patients, for example, detecting hemorrhage and being able to put those cases higher up on a list of studies that we read. 

     “ I don’t see AI replacing radiologists, I see it as a very helpful tool assistant to the radiologists. ”

     A.I. can also help in providing more objective data like measurements and how they change over time. I don’t see it replacing radiologists, I see it as a very helpful tool assistant to the radiologists 

    Do you think that specificity or sensitivity should be taken more into account in AI products, such as false negative and positive detection?

    These measures definitely should be considered carefully when evaluating an AI tool. False negatives can be dangerous. For example, missing a large vessel occlusion is worse than overcalling it because an LVO is a treatable lesion. If left untreated, the patient may have significant morbidity. 

    However,  there are more nuanced situations where a false negative may not be clinically significant. For example, if a tiny intracranial hemorrhage is missed, it may be within acceptable limits since a subtle ICH may not be as clinically significant. It’s important to have a balance between specificity and sensitivity.

    What is the impact of false positives on workflow?

    Having too many false positives can be a problem because, then you can’t trust the AI tool to work effectively, and the radiologist is less likely to even use it. Too many false positives may increase the time that the radiologist spends on a study, which would defeat the purpose of using AI as a fast triage tool. Regardless, the radiologist’s interpretation would need to confirm the final decision-making. Despite these challenges, we remain optimistic as more and more companies bring new solutions combining optimal specificity and sensitivity that could significantly improve radiologists’ workflow and triaging.

  • Sur le marché de la radiologie, Avicenna.Ai se place en challenger

    Sur le marché de la radiologie, Avicenna.Ai se place en challenger

    Sur un marché de plus en plus concurrentiel, Avicenna.AI a choisi de prendre son temps. Ce marché, c’est celui de la radiologie intelligente. Celle qui permet de guider le regard du médecin, de l’aider à détecter des pathologies qui lui auraient échappé à l’œil nu. “Le marché est occupé par des acteurs trop gros pour développer des outils comme le nôtre“, observe Olivier Fuseri, chargé d’affaires de l’entreprise. “Il y a aussi de plus en plus de startups qui organisent d’importantes levées de fonds”.  Face à ces acteurs, Avicenna.Ai a choisi de se placer en challenger. “Nous sommes restés cachés le plus longtemps possible”, le temps de perfectionner sa solution et d’atteindre des performances élevées. Ainsi, alors que la plupart des solutions d’imagerie intelligente indiquent au radiologue le moindre élément anormal – “ce qui lui fait perdre du temps” – le logiciel développé par Avicenna.Ai ne veut l’alerter qu’en cas d’urgence, “avec très peu de faux positifs“.

    Car l’idée est bien d‘offrir à un gain de temps à des radiologues souvent en sous-effectifs, mais aussi d’améliorer la prise en charge du patient.

    Pour l’heure, l’entreprise a développé trois produits capables de détecter, à partir des scanners du malade, des hémorragies intracérébrales et l’occlusion de gros vaisseaux. Des pathologies pour lesquelles chaque seconde compte. “Chaque seconde, des neurones sont perdus et ne seront jamais régénérés“. D’où l’intérêt d’une prise en charge rapide. “Cela permettra un temps de récupération drastiquement réduit avant de reprendre une vie normale”. Et qui dit meilleure récupération dit moins de coûts pour la collectivité et le système de santé. “C’est moins d’interruptions de travail, moins de complications à soigner…”

    En attente d’une certification de la FDA américaine

    Après le temps du développement, place à celui du marquage, plus chronophage. Deux produits ont déjà obtenu la certification européenne, ils attendent son équivalent américain, le marquage par la Food and drug administration (ou FDA). “Les États-Unis sont notre principale cible. Lorsque je discute avec de grosses entreprises internationales, elles m’expliquent qu’elles n’investissent pas dans des entreprises françaises qui ne sont pas capables de travailler pour la FDA”. Un Graal pour lequel il faudra patienter encore quelques mois avant la commercialisation prévue au second semestre de cette année.

    Et le marché est immense. “Tous les centres, y compris les plus petits, ont des scanners” et sont donc des clients potentiels. Mais pour s’adresser à eux, l’entreprise fait le choix de passer par des distributeurs. “Notre but est de travailler au travers de partenaires formés qui connaissent bien les produits“. Il pourra s’agir de marketplaces ou bien de fournisseurs d’outils en radiologie. “Ceux-ci proposent avant tout du matériel et ne font pas de traitement d’images. Leurs clients leur demandent à ce que cela soit ajouté à leurs outils”. Avicenna.Ai vise aussi les fabricants d’IRM et de scanners qui pourraient eux aussi intégrer le logiciel à leurs produits.

    Grâce à ces partenaires, l’entreprise espère voir ses produits présents dans dix à vingt centres de santé d’ici la fin d’année. “Ce sera une année d’incubation pour voir comment le marché se présente“. A terme, l’ambition est de devenir “un des leaders sur l’imagerie d’urgence mais aussi sur d’autres sujets”. L’oncologie pourrait être l’un d’eux. “Cela dépendra des opportunités de recherche qui se présenteront“.

    Lisez l’article de presse en intégralité.