Sam Brusco, Associate Editor03.05.24
Analog Devices Inc. (ADI) has received U.S. Food and Drug Administration (FDA) 510(k) clearance and began commercial launch of its Sensinel cardiopulmonary management (CPM) system.
The company’s compact, wearable device is a non-invasive, remote management system that captures cardiopulmonary measurements to manage heart failure. The FDA clearance of the Sensinel CPM system is the first the company has gained in its 59-year history.
Sensinel CPM has a set of physiological indicators to help care teams manage chronic conditions early, remotely, and precisely. The wearable is self-applied and worn for three to five minutes in a home care environment. Data is captured and uploaded to ADI’s cloud platform using a cellular link, then further analyzed using intelligent algorithms in the cloud.
"Since our founding, ADI has focused on accelerating breakthroughs that enrich lives through innovative products," said Patrick O'Doherty, senior VP 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."
"When managing chronic conditions like heart failure, it is critical to adjust treatment early to get the condition under control without the need for hospitalization. Other existing non-invasive solutions are not specific enough to provide the data a clinician needs to be effective for early intervention," added Dr. Venu Gopinathan, ADI Fellow and managing director of medical products at ADI. "Our new cardiopulmonary system is designed to fit seamlessly into the workflow of care and perform a variety of physiological measurements that allow care teams to make early clinical decisions, without subjecting them to information overload."
The company’s compact, wearable device is a non-invasive, remote management system that captures cardiopulmonary measurements to manage heart failure. The FDA clearance of the Sensinel CPM system is the first the company has gained in its 59-year history.
Sensinel CPM has a set of physiological indicators to help care teams manage chronic conditions early, remotely, and precisely. The wearable is self-applied and worn for three to five minutes in a home care environment. Data is captured and uploaded to ADI’s cloud platform using a cellular link, then further analyzed using intelligent algorithms in the cloud.
"Since our founding, ADI has focused on accelerating breakthroughs that enrich lives through innovative products," said Patrick O'Doherty, senior VP 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."
"When managing chronic conditions like heart failure, it is critical to adjust treatment early to get the condition under control without the need for hospitalization. Other existing non-invasive solutions are not specific enough to provide the data a clinician needs to be effective for early intervention," added Dr. Venu Gopinathan, ADI Fellow and managing director of medical products at ADI. "Our new cardiopulmonary system is designed to fit seamlessly into the workflow of care and perform a variety of physiological measurements that allow care teams to make early clinical decisions, without subjecting them to information overload."