Avicenna.AI Receives FDA Clearance for Two Healthcare AI Solutions

Avicenna.AI, a medical imaging AI company has received FDA 510 (k) clearance for its CINA-iPE and CINA-ASPECTS tools. The company combines deep learning and machine learning technologies to develop AI solutions that automatically and quickly detect and prioritize life-threatening conditions. These solutions also detect for severity and seamlessly notify clinicians.
 
“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,” commented co-founder and CEO, Cyril Di Grandi. “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.”
 
These are the latest Avicenna.AI tools to secure FDA clearance. Other medical emergency solutions include CINA Head including CINA-ICH and CINA-LVO, and CINA Chest including CINA-AD, and CINA-PE.
 
CINA-iPE is an AI-powered tool that can detect incidental pulmonary embolisms and lung blood clots that can occur during CT scans. The tool was validated on 381 CT scans and performed for other clinical indications in addition to pulmonary embolism evaluations. It acquired 39 different scanner models from five leading manufacturers with high sensitivity and specificity results.
 
“From day one, we have been committed to validating our AI tools on every type of CT scanner,” said Clinical Affairs Manager for Avicenna.AI, Yasmina Chaibi. “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 AI tool is designed for stroke severity assessment. It automatically processes non-contrast CT scans and calculates the “ASPECT” score, a topographic scoring system used to quantify the severity of a stroke from a CT scan of the brain.
 
The ASPECT score from a CT scan can also help physicians improve reproducibility in ASPECT scoring, which can vary depending on the radiologist reading the scan. 
 
This tool computes a heat map that indicates the probability of hypodensity and sulcal effacement in the brain and displays a list of infarcted regions. The system then provides CT images that are corrected from tilt to compare the left and right hemispheres. CINA-ASPECT was validated on 200 scans and 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,” Chaibi added. 
 
CINA-ASPECTS is the first tool from Avicenna.AI in the computer-aided diagnosis (CADx) category to gain FDA clearance. Meaning that the system goes beyond identifying abnormalities in scans and provides a severity assessment of the condition.