A new wearable device has received FDA clearance, offering a non-invasive way to monitor heart health and manage chronic diseases like heart failure.
Analog Devices has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sensinel Cardiopulmonary Management (CPM) System, marking the company’s first FDA approval in its 59-year history. This compact wearable device is a non-invasive remote management system that monitors cardiopulmonary measurements to manage chronic diseases like heart failure.
The CPM System is a next-generation solution for managing cardiopulmonary diseases like heart failure. It features a set of physiological indicators to aid care teams in the early, remote, and precise management of chronic conditions. Patients can self-apply the CPM Wearable for three to five minutes at home to capture data on their cardiopulmonary health. This data is automatically uploaded to the CPM Cloud Platform via a cellular link, without requiring a patient-supplied Internet connection, and is analyzed using CPM Intelligent Algorithms in the cloud.
More than 6 million Americans currently live with heart failure, a number expected to increase to nearly 8 million by 2030. The annual cost of heart failure in the U.S. is around $30 billion, projected to rise to almost $70 billion by 2030, with hospitalizations accounting for approximately 80% of these costs. While previous solutions that measure similar parameters have been shown to reduce hospital admissions, many are invasive or lack the sensitivity and specificity needed for significant clinical impact.
“Since our founding, ADI has focused on accelerating breakthroughs that enrich lives through innovative products,” said Patrick O’Doherty, Senior Vice President of Digital Healthcare at ADI. “By combining our wearable vital signs sensing and signal processing technology with cardiologist-inspired algorithms to precisely determine a congestive heart failure patient’s daily health, we developed the Sensinel CPM System. This innovative service-based product has the potential to open up several billion dollars of green-field market opportunity for ADI while improving patient care, streamlining clinician workflows, and reducing healthcare costs.”
