The US Food and Drug Administration (FDA) has granted 510(k) clearance to Analog Devices Inc’s Sensinel cardiopulmonary management (CPM) system, a non-invasive wearable device that captures cardiopulmonary measurements for chronic disease management such as heart failure.

It captures nine specific cardiopulmonary indicators: diastolic heart sound strength, heart sounds, heart rate, relative tidal volume, temperature, thoracic impedance, respiratory rate, body posture, and single-lead ECG to measure heart, lung, and other functions. Patients self-apply Sensinel CPM wearable, which they wear for three to five minutes in a home care setting.

Data is automatically uploaded to the Sensinel CPM cloud platform using a cellular link (without the need for a patient-supplied Internet connection) and is then further analyzed using Sensinel CPM intelligent algorithms.

“Early detection of physiological changes is critical for clinicians to prevent a heart failure hospitalization,” says Sean Pinney, MD, chief of cardiology at Mount Sinai Morningside, in a release. “[The] Sensinel CPM system is a highly accurate, reproducible, and reliable solution to help improve predictive care.” 

More than 6 million Americans are living with heart failure today, and this number is estimated to rise to nearly 8 million by 2030. Heart failure currently costs Americans approximately $30 billion each year, and this is expected to rise to almost $70 billion by 2030. Approximately 80% of those costs are due to hospitalization. 

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, according to a release from Analog Devices.  

“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,” says Venu Gopinathan, PhD, Analog Devices fellow and managing director of medical products at Analog Devices, in a release. “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 Sensinel CPM system is now commercially available.

Photo caption: Sensinel CPM system

Photo credit: Analog Devices Inc