FDA clears wearable, remote cardiopulmonary management system
Key takeaways:
- The FDA cleared a wearable cardiopulmonary management system.
- The system is designed for the remote monitoring of patients with chronic disease such as heart failure.
Analog Devices announced the FDA 510(k) clearance and commercial launch of its wearable, remote cardiopulmonary management system.
The compact system (Sensinel) is designed to capture cardiopulmonary measurements for management of chronic disease such as heart failure, according to a press release from the company.
The device the meant to be self-applied by the patient and worn for 3 to 5 minutes in a homecare setting while the device gathers their cardiopulmonary data and automatically uploads it to the company’s cloud platform, according to the release.
“When managing chronic conditions like heart failure, it is critical to adjust treatment early to get the condition under control without the need for hospitalization. Other existing noninvasive solutions are not specific enough to provide the data a clinician needs to be effective for early intervention,” Venu Gopinathan, PhD, managing director of medical products at Analog Devices, said in the release. “Our new cardiopulmonary system is designed to fit seamlessly into the workflow of care and perform a variety of physiological measurements that allow care teams to make early clinical decisions, without subjecting them to information overload.”
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