Analog Devices’ Sensinel CPM System Receives FDA Clearance for Remote Cardiopulmonary Management

Analog Devices (ADI) has achieved 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Sensinel Cardiopulmonary Management (CPM) System. This non-invasive, wearable and remote management device, specifically designed for chronic disease management like heart failure, offers a breakthrough in healthcare technology. The Sensinel CPM System utilizes wearable vital signs sensing and signal processing technology, along with cardiologist-inspired algorithms, to provide precise daily health assessments for congestive heart failure patients. The device, part of the Sensinel by Analog Devices brand, allows patients to self-apply and wear it for a brief period at home, collecting critical health data that is then transmitted to the Sensinel CPM Cloud Platform through a cellular connection. With potential applications to improve patient care, streamline clinician workflows, and reduce healthcare costs, ADI anticipates a significant market opportunity for the innovative Sensinel CPM System.

ADI Digital Healthcare's Senior Vice President, Patrick O’Doherty, expressed confidence in the system's ability to manage chronic conditions effectively from a distance, emphasizing its contribution to early clinical decisions without overwhelming healthcare professionals with information. The Sensinel CPM System's commercial availability marks a milestone in advancing remote healthcare solutions and addressing critical needs in chronic disease management.

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