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02/06/202106/05/2022

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.”

27/05/202109/05/2022

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.”

24/11/202006/05/2022

Stroke Detection AI Tool Approved for Medicare NTAP

Paris, FRANCE – November 24th, 2020 – Medical imaging AI specialist Avicenna.AI today announced that its CINA Head software qualifies for the new technology add-on payment (NTAP) recently approved by the Centers for Medicare & Medicaid Services (CMS).

The NTAP is available for radiological computer-assisted triage and notification software systems like CINA Head, which analyzes computed tomography angiogram (CTA) images and urgently notifies clinical team members when a suspected large vessel occlusion (LVO) has been identified to reduce time to treatment.

Dr Peter Chang, radiologist and co-founder of Avicenna.AI, said, “AI-enabled CT stroke triage, specifically with LVO detection, is the first deep learning tool to receive the CMS NTAP designation and is eligible for up to $1040 of reimbursement. CMS only grants NTAP designation to promote the adoption of new technology that provides substantial clinical improvement over standard of care. This will help accelerate the innovation and adoption of deep learning technology by aligning the incentives of both software developers and clinical providers.”

In addition to LVO detection, Avicenna’s FDA-approved CINA Head triage AI solution for neurovascular emergencies also detects intracranial hemorrhages (ICHs). Using a combination of deep learning and machine learning technologies, CINA Head automatically detects and prioritizes acute ICH and LVO cases from CT-scan imaging within 20 seconds, seamlessly alerting the radiologist within their existing systems and workflow.

Avicenna.ai: NTAP information for customers

Avicenna.AI believes that there is a strong argument that the CINA Head triage solution is substantially similar to the applicant technology and that the same ICD-10-PCS code may be used to describe the use of CINA Head.

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14/07/202006/05/2022

Avicenna.AI secures FDA clearance for its CINA neurovascular imaging Tool

CINA supports emergency room triage for intracranial hemorrhages and large vessel occlusions.

Paris, FRANCE – July 14, 2020 – Medical imaging AI specialist Avicenna.AI today announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its CINA triage AI solution for neurovascular emergencies. The FDA’s decision covers CINA’s automatic detection capabilities for both intracranial hemorrhage (ICH) and large vessel occlusion (LVO) from CT-scan imaging.

Stroke is a leading cause of death in the US, with more than 795,000 strokes resulting in more than 100,000 deaths each year. It is estimated that up to a third of the most common type of stroke are caused by LVO, when a clot blocks the circulation of the blood in the brain. Around 1 in 10 strokes are thought to be caused by ICH, or bleeding that occurs inside the skull. Using a combination of deep learning and machine learning technologies, CINA automatically detects and prioritizes acute ICH and LVO cases within 20 seconds, seamlessly alerting the radiologist within their existing systems and workflow.

Dr. Peter Chang, radiologist and co-founder of Avicenna.AI, said, “When dealing with a stroke, time is of the essence and being able to prioritize effectively is critical to saving lives and improving outcomes. Not only does CINA helps radiologists to identify pathologies quickly, but also to highlight those that require the most urgent care.”

CINA’s ICH detection capability was validated using data from 814 cases conducted at more than 250 imaging centers across the United States, with 96% accuracy, 91.4% sensitivity, and 97.5% specificity. The product’s LVO detection capability was validated based on 476 cases, with 97.7% accuracy 97.9% sensitivity, and 97.6% specificity.

Cyril Di Grandi, co-founder, and CEO of Avicenna.AI, said, “We’re excited to have received FDA clearance for CINA and we are looking forward to working with emergency departments and stroke centers across the United States to help improve detection, decision-making and patient outcomes. As a triage AI tool that identifies multiple pathologies, we believe that CINA delivers more value than AI tools or algorithms that only target a single condition.”

CINA is the first in a family of AI tools for emergency radiology being developed by Avicenna.AI. Subsequent products spanning the trauma and vascular fields are expected to be unveiled in the next 12 months.

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