BlineSlide

“Blineslide is a cloud service application that helps qualified users with image-based assessment of lung ultrasound (LUS) cines acquired from the anterior or anterolateral chest regions during a physician-led LUS examination of patients aged 18 years or older. It does not directly interface with ultrasound systems.”

“B Line Artifact Module: an AI-assisted tool for detecting the presence or absence of B line artifacts in LUS cines. Ultrasound image processing software implementing artificial intelligence including non-adaptive machine learning algorithms trained with clinical data intended for non-invasive analysis of ultrasound data. Deep convolutional neural networks for segmentation or landmark detection”

“Ultrasound image processing software implementing artificial intelligence including non-adaptive machine learning algorithms trained with clinical data intended for non-invasive analysis of ultrasound data”

“A comprehensive cybersecurity assessment was performed in accordance with FDA's premarket cybersecurity guidance and industry best practices. The device underwent penetration testing, vulnerability scanning, and a Common Vulnerabilities and Exposures (CVE) analysis. Identified threats were reviewed and mitigated using accepted controls, and no unmitigated high-severity vulnerabilities remained at the time of release.”