FDA clears AI-based wearable device to monitor hospital patients

The Food and Drug Administration has approved a wireless device that continuously and automatically monitors patients using artificial intelligence to provide clinicians with actionable insights.

Scottish company Current Health, the manufacturer of the wearable device, announced on Wednesday that it has received Class II clearance from the FDA for hospital care.

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According to the vendor, the device monitors patients’ vital signs using proprietary algorithms that continuously analyze the data to help better predict their health trajectory and to enable clinicians to intervene earlier and improve outcomes.

In addition, the company contends that its patient monitoring solution seamlessly integrates with third-party devices, capturing additional metrics, as well as creating customized digital therapeutics and recommendations.

“The Mount Sinai Health System works with innovative and leading-edge companies like Current to support our commitment to providing world-class patient care,” said Scott Lorin, MD, president of Mount Sinai Brooklyn, in a written statement. “Current’s continuous and proactive monitoring platform has the potential to alert us to patient deterioration faster and give our team data insights they can act on earlier.”

Worn on the upper arm, the device non-invasively captures vital signs with ICU-level accuracy, providing automatic alerts for deteriorating patients, according to Current. The system also provides direct transmission of the data to the electronic health record through an HL7 or Fast Healthcare Interoperability Resources (FHIR) integration.

“At Current, we’re a small team of individuals committed to changing the world through proactive healthcare,” said Christopher McCann, CEO of Current. “Our team worked hard to get here, and it’s just the first step toward monitoring the health of every human being to identify sickness earlier with the goal of saving lives. Today, we’re in the hospital, tomorrow the home, and in the near future, we’ll be everywhere. We are just getting started.”