FDA clears Current Health’s hospital-to-home wearable, combining analytics and passive vital sign tracking

The FDA has cleared Current Health’s wearable tracker, designed to be taken home from the hospital after acute care to track a patient’s recovery in real time, with the ultimate goal of reducing readmissions.

The 510(k) clearance covers the Class II device and Current’s telehealth platform, which offers a dashboard for physicians, AI-based risk prediction and alerts, as well as secure video chat.

Meanwhile, the patient-facing side—delivered via a Current-issued tablet—includes medication reminders, automated symptom questionnaires and HIPAA-compliant text messaging.

Current’s passive device, worn on the upper arm, tracks vital signs with accuracy akin to the hardware found in an intensive care unit, according to the company. The device also received an FDA clearance earlier this year for its use within the hospital, to track movement, pulse, respiration rate, temperature and blood oxygen level.

Current Health's wearable. (Image: Current)

The company sees the device as a useful tool for hospitals, as the industry moves toward value-based care centered on patient outcomes—where decreasing lengths of stay and avoiding unnecessary hospitalizations will be a financial imperative. So far, Current has partnered with six health systems in the U.S., including Mount Sinai, along with several U.K. NHS Trusts.

“Our rapidly growing customer base indicates how focused health systems and home health agencies are on moving more healthcare from hospital to home,” Current CEO and co-founder Christopher McCann said in a statement.

“Today, Current is helping them do just that by monitoring patients’ health trajectories to enable earlier interventions, reduce the overall and growing cost of hospital readmissions and, more importantly, prevent avoidable deaths,” McCann added.

“But more fundamentally, we’re building a future where healthcare comes to us,” he said. “Patients don’t always know when to call their doctor. Current will.”