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Avicenna.AI Receives FDA Clearance for Two Healthcare AI Solutions

Wednesday, March 27, 2024

Avicenna.AI, a medical imaging AI company, announced today that it has obtained 510(k) clearance from the US Food and Drug Administration for its CINA-iPE and CINA-ASPECTS products. These tools utilize a blend of deep learning and machine learning technologies to automatically identify and prioritize critical conditions within seconds, aiding clinicians in prompt diagnosis and treatment decisions.

CINA-iPE is designed to detect incidental pulmonary embolism during routine CT scans, addressing the challenge of missed findings in diagnostic imaging. It identifies blood clots in the lungs detected during scans performed for various health conditions, including those in cancer patients where pulmonary embolism poses a significant risk. Validation studies on diverse CT scans and scanner models have demonstrated its high sensitivity and specificity.

On the other hand, CINA-ASPECTS offers assistance in stroke severity assessment by analyzing non-contrast CT scans and calculating ASPECT scores. This tool provides a heat map indicating areas of concern in the brain and facilitates comparison between hemispheres. Validated on numerous scans from various scanner models, it not only performs exceptionally well on its own but also improves clinician accuracy in ASPECT scoring.

These FDA clearances mark significant progress for Avicenna.AI in its mission to enhance patient care through advanced AI solutions. By seamlessly integrating into existing clinical workflows, CINA-iPE and CINA-ASPECTS contribute to more efficient and accurate diagnostic processes. These achievements highlight the dedication and expertise of the Avicenna.AI team in addressing critical healthcare challenges.

Source: prnewswire.com

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