GE Healthcare's Revolutionary Pneumothorax Detection Algorithm Gains First-of-Its-Kind FDA Clearance, Advancing On-Device Triage in Critical Care Suite

GE Healthcare has recently obtained FDA 510K clearance for its Critical Care Suite 2.1, marking an industry milestone. This version introduces a Pneumothorax (PTX) algorithm designed for the prompt detection, notification, triage, and diagnosis of PTX. The updated algorithm expands the on-device triage capabilities of Critical Care Suite, providing instant notifications about the presence or absence of pneumothorax. It also includes an overlay display on the device and in PACS to assist in PTX localization.

The significance of X-ray as a crucial imaging tool in patient care cannot be overstated, with over 60 percent of all imaging exams being X-rays. Given the continuous pressure faced by technologists, radiologists, and physicians to manage an increasing number of cases, especially those requiring immediate attention ("STAT" orders), time becomes a critical factor. Critical Care Suite 2.1 addresses this challenge by offering immediate on-device detection and triage notifications for pneumothorax.

Functioning as the entry point to diagnostic imaging in emergency rooms, inpatient bedside imaging, and intensive care units (ICUs), GE Healthcare strives to redefine mobile X-ray as an intuitive and technologically powerful imaging tool. With the latest update, Critical Care Suite 2.1 not only provides on-device detection and triage notifications but also displays overlays for improved localization of pneumothorax, enhancing speed and accuracy in diagnosis.

This innovative solution was co-developed with UCSF's Center for Digital Health Innovation, leveraging GE Healthcare's AMX platform as the first mobile X-ray system worldwide to embed artificial intelligence for triage on-device. Besides on-device AI notifications, the AI output seamlessly integrates with PACS through a secondary capture DICOM image, eliminating the need for additional IT infrastructure. The robust AI algorithm, trained on a diverse global dataset of over 30,000 images from various countries and institutions, ensures comprehensive and accurate support for clinicians in critical care scenarios.


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