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.