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GE HealthCare wins FDA clearance for wireless hospital vital sign monitor

The Portrait Mobile device is one of GE HealthCare’s “first major introductions in monitoring in recent years,” according to the company.

GE HealthCare has received 510(k) clearance for its device called Portrait Mobile, which allows hospitals to continuously monitor patients’ vital signs while they are able to move around the ward. This device combines wireless patient-worn sensors with a smartphone-style monitor, providing a first-of-its-kind solution that untethers patients from their beds without compromising oversight. The clearance from the U.S. Food and Drug Administration follows the approval of GE HealthCare’s Carescape Canvas patient monitoring platform four months prior. These two products are considered the company’s first major introductions in monitoring in recent years.

Traditionally, monitoring vital signs in hospitals involved a tradeoff between continuous oversight with bedside devices or periodic manual readings. With Portrait Mobile, patients can freely move while wearing the device, benefiting their mental health and recovery, while hospitals maintain a round-the-clock view of their vital signs. The sensors monitor respiration rate, blood oxygen, and pulse rate, and the system can be customized to alert the ward when certain thresholds are reached. Hospitals have the flexibility to set limits and delays on alarms.

During a conference call with investors, GE HealthCare CEO Peter Arduini highlighted the company’s investment in monitoring solutions for critical care and acute patients, with Portrait Mobile and Carescape Canvas as major new products. Arduini emphasized that Portrait Mobile allows care teams to continuously monitor patients, shifting from periodic spot checks to continuous monitoring, ultimately freeing patients from their beds while ensuring signs of patient decline are detected. These new monitoring solutions present opportunities for both upgrades to existing installations and new growth for the company.

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