FDA News

GE Healthcare Receives FDA Clearance For CARESCAPE Patient Data Module For Mobile Patient Monitoring

(May 28, 2007)-- GE Healthcare announced recently U.S. Food and Drug Administration (FDA) clearance for its CARESCAPE Patient Data Module for mobile patient monitoring. Reflecting the advanced monitoring capabilities, the CARESCAPE Patient Data Module features 24-hour capture of critical patient data and a unique close-to-the-patient, self-powered design that alleviates common portability constraints. The product is a central component of the new GE CARESCAPE portfolio, an integrated suite of patient monitoring devices, communications networks and IT systems designed to transform traditional patient monitoring data into clinical intelligence, enabling clinicians to make critical healthcare decisions faster and more efficiently.

CARESCAPE Patient Data Module ensures that the receiving nurse has a complete monitoring history when a patient arrives. Advancing GE’s history of parameter excellence and the customer-proven success of the predecessor product, TRAM, CARESCAPE Patient Data Module reflects more than 10,000 hours of testing and feedback from more than 700 clinicians. Its innovative, lightweight, miniature design allows it to stay with the patient to capture and store all patient measurements-both standard and specialty-providing clinicians with the unique ability to maintain critical baseline measurements typically lost during transport. Its close-to-the-patient design reduces the length of cables that typically tether the patient to wall-mounted equipment, and its simple grab-and-go transport capability reduces the potential for connection delays.

CARESCAPE Patient Data Module is the latest addition to GE Healthcare’s CARESCAPE portfolio of innovative patient monitoring products. CARESCAPE products feature parameter excellence, superior device integration and control and clinical decision support capabilities combined with a wireless infrastructure that supports the secure, uninterrupted transmission of patient information. Unifying previously un-integrated streams of patient data, the CARESCAPE portfolio offers a new approach to patient monitoring by assimilating critical patient data and offering easy access to clinical intelligence from wireless and stationary devices. This enables clinicians to make critical healthcare decisions faster, which may lead to improvements in patient care.

“Humans can only assimilate so much un-integrated information. The power of systems—whether it’s a physiologic monitor or IT system or ideally a system that combines those functions—is to integrate the information and then use it optimally,” said M. Michael Shabot, M.D., Director of Surgery Critical Care, Cedars-Sinai Medical Center in Los Angeles, California (2006). “That’s where the real power comes from. It is the way quality and safety will be measured, and the way data will be managed in ICUs in the future.”

“The traditional approach to patient monitoring has outlived its usefulness,” said David Ataide, Vice President & General Manager for GE Healthcare’s Monitoring Solutions business. “Clinicians facing today’s healthcare challenges need a new approach. After extensive interviews with some of the world’s most forward-thinking hospitals, we developed CARESCAPE. These five products reflect our commitment to helping care providers do their jobs better and ultimately improve patient care.”

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