Analog Devices’ Sensinel Cardiopulmonary Management System Cleared by FDA

March 5, 2024—Analog Devices, Inc. (ADI), a semiconductor company, announced FDA 510(k) clearance and the commercial launch of the Sensinel cardiopulmonary management (CPM) system. The compact, wearable device is a noninvasive, remote management system that captures cardiopulmonary measurements for chronic disease management such as heart failure.

The Sensinel CPM system is the first product in the company’s new Sensinel by Analog Devices wearable health care line. The FDA clearance is the first in the company’s 59-year history.

According to the company, the Sensinel CPM system is equipped with a set of physiologic indicators to help care teams better manage chronic conditions early and remotely, as well as in a precise manner.

The Sensinel CPM Wearable is applied by the patients and worn for 3 to 5 minutes in a home care setting. The device then captures data about the patient’s cardiopulmonary health. These data are automatically uploaded to ADI’s Sensinel CPM Cloud Platform using a cellular link (without the need for a patient-supplied internet connection). The data are then further analyzed using ADI’s Sensinel CPM Intelligent Algorithms in the cloud.

“Early detection of physiological changes is critical for clinicians to prevent a heart failure hospitalization,” commented Sean Pinney, MD, in the company’s press release. “ADI’s Sensinel CPM system is a highly accurate, reproducible, and reliable solution to help improve predictive care.” Dr. Pinney is Chief of Cardiology at Mount Sinai Morningside in New York, New York.