Press release
ADI Announces U.S. FDA 510(k) Clearance and the Commercial Launch of Sensinel by Analog Devices™ Cardiopulmonary Management (CPM) System
Enabling closer remote patient monitoring and reduced healthcare costs WILMINGTON, Mass., March 5, 2024 /PRNewswire/ -- Analog Devices, Inc. (Nasdaq: ADI)
About this update from Analog Devices, Inc.
[{"type":"text","content":"Enabling closer remote patient monitoring and reduced healthcare costs\nWILMINGTON, Mass., March 5, 2024 /PRNewswire/ -- Analog Devices, Inc. (Nasdaq: ADI) today announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the commercial launch of the Sensinel™ Cardiopulmonary Management (CPM) System. The compact wearable device is a non-invasive, remote management system that captures cardiopulmonary measurements for chronic disease management such as heart failure. It is the first FDA clearance the company has received in its 59-year history.\n\n \n \n \n \n \n \n\n \n\"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 state of 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 cost.\"\nMore than 6 million Americans are living with heart failure today, and this number is estimated to rise to nearly 8 million by 2030.¹ Heart failure currently costs Americans approximately $30 billion each year, and this is expected to rise to almost $70 billion by 2030.¹ Approximately 80% of those costs are due to hospitalization.¹ Other prior solutions measuring similar parameters have shown the ability to reduce hospital admissions. However, oftentimes these solutions are either invasive and/or do not provide sensitive and specific enough data to make a meaningful clinical impact. This data is critical to allow the care team to predict an event early enough in advance to potentially avoid a costly hospitalization for the patient. \nThe Sensinel CPM System is the next-generation solution for management of cardiopulmonary diseases like heart failure. It is equipped with a set of physiological indicators to help care teams better manage chronic conditions early and remotely, as well as in a precise manner. Patients self-apply ADI's Sensinel CPM Wearable which they only wear for three to five minutes in a...