Avicenna.AI’s Cina-iPE and Cina-ASPECTS Solutions Receive FDA Clearance

March 26, 2024—Avicenna.AI announced that it received FDA 510(k) clearance for Cina-iPE and Cina-ASPECTS. Cina-iPE enables incidental detection of pulmonary embolism (PE), and Cina-ASPECTS provides automatic assessment of stroke severity.

The company stated it uses a combination of deep learning and machine learning technologies to develop artificial intelligence (AI) solutions that automatically detect and prioritize life-threatening conditions within seconds, assess them for severity, and seamlessly notify clinicians.

Cina-iPE is an AI-powered tool that detects incidental PE during routine CT scans and is intended to address delayed and missed findings in diagnostic imaging.

According to the company, unsuspected PE is a common finding in routine CT scans of the chest, but as little as 25% of emboli are reported during the initial interpretation.

Avicenna.AI stated that the Cina-iPE algorithm identifies lung blood clots detected during routine CT scans for 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 Cina-iPE tool was validated on 381 CT scans (performed for clinical indications other than PE evaluation) acquired on 39 different scanner models from five leading manufacturers, achieving excellent sensitivity and specificity.

The Cina-ASPECTS is an AI tool for stroke severity assessment, automatically processing noncontrast CT scans and calculating the ASPECTS (Alberta Stroke Program Early CT Score). 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, stated Avicenna.AI.

In addition to assisting clinicians in the evaluation of ASPECTS from CT scans, Cina-ASPECTS also helps improve physicians’ reproducibility in ASPECTS determination, which often varies depending on the radiologist reading the scan. The tool was validated on 200 scans acquired on 27 scanner models from four leading manufacturers.

Cina-ASPECTS is the company’s first FDA-cleared tool in the category of computer-aided diagnosis. It goes beyond identifying abnormalities in scans to provide an assessment of the severity of a condition.

The company advised that Cina-iPE and Cina-ASPECTS join Avicenna.AI’s portfolio of FDA-cleared AI solutions for medical emergencies, including Cina-ICH for automatic detection of intracranial hemorrhage, Cina-LVO for large vessel occlusion, Cina-AD for aortic dissection, and Cina-PE for pulmonary embolism.