GE HealthCare’s Portrait Mobile Wireless Monitoring Tool Gains FDA Nod

GE HealthCare has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Portrait Mobile wireless, wearable patient monitoring solution.
 
Portrait Mobile allows real-time, continuous monitoring with a personalized view of patient vitals. It also keep patients mobile during recovery periods, particularly after surgery or discharge from the intensive care unit (ICU).
 
GE HealthCare has worked on modernizing respiration rate measurement through novel, wireless sensor technology. Portrait Mobile’s dual-vector respiration rate measurement uses an innovative algorithm engineered for mobile patients, capturing continuous respiratory rate via optimized 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,” Dr. Daniel Sessler, Michael Cudahy Professor and Chair of Outcomes Research at Cleveland Clinic, as well as the Principal Investigator for a joint trial currently evaluating Portrait Mobile, told the press. “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.”
 
Uninterrupted flow of data and continuous measurement of respiration rate, oxygen saturation and pulse rate, can help healthcare providers spit patient decline as it’s occurring, allowing timely intervention before a patient deteriorates.
 
Portrait Mobile is part of the company’s FlexAcuity monitoring tools that combine hardware and software to adapt to changing patient needs. The tech received the iF Design Gold Award for Product Design in 2022 for Portrait Mobile and an iF Design Award in 2023 for CARESCAPE Canvas.

 
“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, monitoring solutions, GE HealthCare. “Until Portrait Mobile, patient monitoring required that patients be tethered to their beds, limiting mobility. GE HealthCare designed Portrait Mobile with this need in mind – the advent of a small wearable, wireless inpatient monitoring solution that provides reliable monitoring to the patient’s care team, while allowing for more patient freedom and flexibility during recovery, is an important advancement in acute care.”