GE Healthcare's Wireless Monitoring for Early Patient Deterioration Detection Gets FDA Clearance 

The Portrait Mobile by GE Healthcare is an innovative wearable solution that offers real-time personalised insights into patient health. It promotes patient mobility while continuously monitoring dual vector respiration rate, SpO2, and pulse rate wirelessly. 

GE Healthcare announced receiving 510(k) clearance from the United States Food and Drug Administration (FDA) for its Portrait Mobile wireless and wearable monitoring solution. The Portrait Mobile platform enables real-time continuous monitoring with a personalised view of the patient's vitals while keeping patients mobile during critical recovery periods, especially after surgery or discharge from the intensive care unit.  

The 510(k) clearance is an FDA process where medical device manufacturers demonstrate the new device's safety and effectiveness compared to a legally marketed device (predicate) to gain approval for market entry. 

Continuously monitoring patients and having a real-time data view can help clinicians recognise deterioration earlier than traditional spot-check methods, typically occurring only every 4-6 hours. The wireless patient-worn sensors combined with the smartphone-sized monitor eliminate all traditional tethers, allowing patients to move about the ward freely, which is key to helping improve outcomes and reduce the length of stay. 

Portrait Mobile draws on GE Healthcare's track record in parameter excellence to modernise respiration rate measurement through novel wireless sensor technology. The system's dual-vector respiration rate measurement technology leverages an innovative algorithm designed for mobile patients, better capturing continuous respiratory rate through optimised electrode placement even with changing breathing patterns. 

"Patients recovering from major surgery are fragile. Most patients currently have vital signs monitored every 4-6 hours. We have shown that vital sign abnormalities are common '“ and sometimes profound and prolonged," said Dr. Daniel Sessler, Michael Cudahy Professor and Chair of Outcomes Research at Cleveland Clinic and the Principal Investigator for a joint trial currently evaluating Portrait Mobile.  

Sessler further noted, "Many potentially serious episodes of instability are missed with intermittent vital sign assessments. Continuous vital sign monitoring might help clinicians identify patients who are having difficulty so they can provide help quickly." 

Undetected patient deterioration, particularly post-surgery, can lead to hazardous yet preventable consequences, with 30-day mortality after surgery representing the 3rd leading cause of death globally. The uninterrupted flow of data and continuous measurement of vital signs, such as respiration rate, oxygen saturation, and pulse rate, can help healthcare providers detect patient decline as it is happening, enabling timely intervention before a patient deteriorates. 

"It's important for recovery that patients be able to move around freely while their vital signs are being monitored," said Neal Sandy, general manager of monitoring solutions at GE Healthcare.  

Portrait Mobile is part of GE Healthcare's FlexAcuity monitoring solutions that combine hardware and software engineered to adapt to rapidly changing patient needs and build on a well-established history of clinical advancements. This deep understanding of patient needs, and a commitment to providing caregivers with actionable insights led GE Healthcare's global engineers to develop this next evolution in patient monitoring technology.  

GE Healthcare is a global medical technology, pharmaceutical diagnostics, and digital solutions innovator. Apart from Portrait Mobile, GE Healthcare has pioneered several health-tech advancements. These include state-of-the-art medical imaging equipment like MRI and CT scanners for accurate diagnoses, AI-powered data analytics to enhance patient outcomes and streamline hospital operations, real-time monitoring devices for comprehensive patient insights, and investments in telehealth and remote monitoring technologies for remote patient care.