GE HealthCare Receives FDA Clearance for Portrait Mobile Patient Monitoring Device

GE HealthCare announced August 14th it has received 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 personalized 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 device helps healthcare providers detect patient decline

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.

GE HealthCare’s smartphone-sized Portrait Mobile frees the patient from the hospital bed while providing continuous monitoring of vital signs, using wearable sensors with a wireless protocol, to help catch inpatient deterioration early.  

Portrait Mobile introduces an innovative measurement technology to continuously capture respiration rate, one of the most sensitive vital signs for early patient deterioration, accurately and reliably.

Continuously monitoring patients and having a real time view of data can help clinicians recognize deterioration earlier than traditional spot check methods, which typically occur 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, key to helping improve outcomes and reduce length of stay.

Respiration rate measurement through new wireless sensor technology

Portrait Mobile draws on GE HealthCare’s track record in parameter excellence to modernize respiration rate measurement through novel wireless sensor technology. 

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 builds on a well-established history of clinical advancements. It was this deep understanding of patient needs combined with a commitment to providing caregivers with actionable insights that led GE HealthCare’s global engineers to develop this next evolution in patient monitoring technology. 

The system’s dual-vector respiration rate measurement technology leverages an innovative algorithm designed for mobile patients, better capturing continuous respiratory rate through 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,” shares 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. “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.”

“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.”

Innovation in technology assisting with health issues gets recognition for revolutionizing care  

GE HealthCare’s technology has been recognized globally for its design, receiving the iF Design Gold Award for Product Design in 2022 for Portrait Mobile and an iF Design Award in 2023 for CARESCAPE Canvas. Last year was a good one for the company, which kept announcing new revolutionary products. At the European Association of Nuclear Medicine (EANM) Annual Meeting in Barcelona, Spain, GE Healthcare proudly introduced Omni Legend, the first system on its all-new, all-digital PET/CT platform.

A month ago, the company announced promising second quarter financial results. GE HealthCare President and CEO Peter Arduini said: “We are pleased with organic orders growth of 6% for the second quarter reflecting ongoing strong global demand, and we continued to see revenue growth across our segments. We’ve made good progress with our operating priorities in the first half of the year. As a result, we’re raising our top- and bottom-line guidance for the full year as we execute our precision care strategy.”

Patient monitoring is not the only field the company is trying to innovate in. Back in 2021, GE Healthcare announced plans to work with SOPHiA GENETICS on advancing cancer care, with the goal of better targeting and matching treatments to each patient’s genomic profile and cancer type, helping to ensure the most effective and personalized treatment.

About GE Healthcare Technologies Inc.

GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 100 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together, their Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from prevention and screening, to diagnosis, treatment, therapy, and monitoring. GE Healthcare is an $18 billion business with 50,000 employees.