A wearable device that uses machine learning to remotely track and analyze multiple vital signs has been cleared by the Food and Drug Administration, expanding the scope of home monitoring systems intended to keep chronically ill patients out of the hospital.
Current Health, based in Edinburgh, Scotland, announced Wednesday it received clearance for an upper-arm wearable that measures a patient’s respiration, pulse, oxygen saturation, temperature and mobility. The product is capable of delivering continual updates on a patient so doctors can intervene quickly if the data signal an emerging problem.
The device, called Current, is already used in hospitals, and the clearance means it can monitor patients at home, in between visits with their doctors. It uses machine learning to analyze the data it collects and notifies doctors of problematic changes on their mobile devices or in electronic health records.
“As health systems seek to shift more health care out of the hospital and into the community, they need some way of maintaining visibility on those patients at home, and that’s exactly what we’re giving them,” said Christopher McCann, Current Health’s chief executive.
He said the device is most commonly used by patients with heart failure and chronic obstructive pulmonary disease, conditions that come with high rates of hospitalization and significant costs.
U.S. health officials have targeted the care of those patients to reduce expenses. Hospitals face financial penalties for racking up excess readmissions of heart failure patients, an initiative that has encouraged many providers to deploy remote monitoring tools to keep tabs on their conditions. The technologies are also gaining traction because health systems are increasingly able to incorporate the data into their electronic health records and other IT systems.
“It’s exciting to see these types of technologies crop up,” said Dr. Daniel Cantillon, a cardiologist at the Cleveland Clinic who has worked with remote monitoring systems. He has no relationship with Current Health.
“Not all of these products are going to be useful additions to our portfolio,” Cantillon added. “If it increases patient connectivity, without bogging down physicians and nurses [with extraneous data], it’s always going to be welcome.”
Current Health’s product is part of a wave of new wearable devices that can be used to monitor heart and lung function as well as changes in weight, body temperature, activity levels, and a wide range of other metrics. AliveCor and Apple have received FDA signoff for products that are designed to detect atrial fibrillation, an irregular heart rhythm that increases risk of stroke.
The agency has also approved several other products that use artificial intelligence to speed up diagnosis of stroke and detection of eye conditions such as diabetic retinopathy.
McCann said Current Health’s device is designed to be used in consultation with doctors, who work with the company to determine what changes in the data should trigger a notification. In the future, he said, the company wants to further automate the process by using the data to predict when a patient is about to decline, rather than providing just the threshold data requested by physicians.
But that capability depends on the company collecting more data on users and refining its algorithms. Even then, McCann said, physician oversight will still be required.