GE HealthCare Receives FDA Clearance of Critical Care Suite 2.1 for Pneumothorax Detection, Notification, Triage and Diagnosis

GE HealthCare has announced the industry’s first US FDA 510K clearance for Critical Care Suite 2.1, which includes a pneumothorax (PTX) detection, notification, triage and diagnosis algorithm that enhances Critical Care Suite’s on-device triage capabilities by providing immediate notification of the presence or absence of pneumothorax, as well as an on-device and PACS overlay display to aid in PTX localisation.

With this latest update, Critical Care Suite 2.1 provides immediate on-device detection and triage notification for the presence or absence of a pneumothorax (PTX). When a PTX is detected, an overlay is displayed in the area where the PTX was located, both on the device and in the PACS, to aid in PTX localization and improve the speed and accuracy of PTX diagnosis. By hosting Critical Care Suite on the device, critical insights are available at the point of care and to the entire clinical care team.

The algorithm works with a high degree of accuracy – partially localising 100% of all detected large PTX and 96% of all detected small PTX, while limiting false alarms (94% specificity). Results from various clinical studies have also shown significant user benefits when using this technology, including a 57% reduction in reporting time for clinically actionable PTXs and a 17.7% increase in clinician detection of small PTXs.

Artificial intelligence applications in healthcare continue to prove their value in clinical practice and at the frontline of patient care. The adoption of these digital solutions is helping to drive efficiencies across the entire clinical workflow and empowering radiologists and their teams to make critical decisions with confidence in time-sensitive situations,” said Jyoti Gupta PhD, President & CEO of Women’s Health and X-ray for GE HealthCare.

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