A wearable device that uses artificial intelligence to remotely track and analyze multiple vital signs while worn by patients at home has been cleared by the Food and Drug Administration.
The AI-powered wearable remote patient monitoring device from Edinburgh, Scotland-based Current Health received Class II clearance from the FDA for post-acute care, marking the first time that an end-to-end, real-time, passive RPM wearable and platform has received clearance from the agency, officials from the company said.
The device, an upper-arm wearable, is already used in hospitals and measures a patient’s respiration, pulse, oxygen saturation, temperature and movement. According to the company, the device delivers continuous “ICU-level accuracy” with analytics to derive actionable insights to enable clinicians to monitor patients’ health and intervene earlier if the data signal an emerging problem.
The device expands the capabilities of remote monitoring systems to help keep chronically ill patients at home and out of the hospital.
The company already has partnered with six of large U.S. health systems, including Mount Sinai Health System, and with several U.K. National Health Service Trusts, assisting them in delivering healthcare at home earlier to reduce readmissions and preventable deaths.
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“Our rapidly growing customer base indicates how focused health systems and home health agencies are on moving more healthcare from hospital to home,” Current Health CEO and co-founder Christopher McCann said in a statement.
As the healthcare industry shifts to value-based care, providers must intervene earlier to improve patient outcomes, decrease lengths of stay and reduce hospital readmissions. However, providers have no means of identifying at-risk patients after they leave the hospital.
“Traditional remote patient monitoring and telehealth solutions cannot meet these challenges due to continued reliance on manual data entry, unreliable spot measurements, a lack of widespread adoption and low patient adherence,” company officials said.
"Real-time, at-home monitoring of vitals allows our team to proactively act on early signs of health decline, preventing avoidable hospitalizations,” Neta Faynboym M.D., executive director of innovation for Medicare Advantage/affordability at Banner Health, said in a statement.
The wearable device has a 90% patient adherence rate in at-home settings, nearly double the national standard, and the company has demonstrated reduced readmissions and ED visits when used at home, according to McCann in a blog post.
Hospital at Home care teams at Dartford and Gravesham NHS Trust in England were able to reduce unnecessary home visits by 22% among patients using the wearable device at home, which enabled care teams to prioritize patient visits based on those most at-risk, according to a case study.
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Current Health officials said the device was developed using one of the world’s largest physiological data sets and the company’s proprietary algorithms continuously analyze data to derive a patient’s health trajectory by detecting potential indicators of patient decline earlier for faster intervention.
The company received FDA clearance for its entire RPM and telehealth platform, which includes Bluetooth integrations with other devices to track metrics. Patients receive a tablet equipped with a chatbot for Q&A, medication reminders and educational content, which lets patients connect with clinicians via video chat or text message to report symptoms and discuss care.
The company received Class II FDA clearance for its device for in-hospital use in February.