US approval for first ADI heart monitor system
The US Food and Drug Administration (FDA) has approved the use of the first heart monitor system developed by Analog Devices (ADI).
The Sensinel Cardiopulmonary Management (CPM) system is a compact wearable device that captures cardiopulmonary measurements for chronic disease management such as heart failure and marks ADI moving into end products.
This is the first FDA clearance the company has received in its 59-year history, as the company supplies components from data converters to amplifiers rather than end systems and cloud services with AI analysis algorithms.
“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.”
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More than 6 million people in the US are living with heart failure, and this is expected to rise to nearly 8 million by 2030. Heart failure currently costs $30 billion each year, and this is expected to rise to almost $70 billion by 2030 and 80% of those costs are due to hospitalisation.
This is driving increased focus on wearable monitors that can be used in the community, but these require regulatory approval so that the data can be used reliably.
Other wearables measuring similar parameters have shown the ability to reduce hospital admissions but these 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 hospitalisation for the patient.
Instead patients use the Sensinel CPM system for three to five minutes to captures data about their cardiopulmonary health. This data is automatically uploaded to ADI’s Sensinel CPM Cloud Platform using a cellular link without the need for a patient-supplied Internet connection. The data is then further analysed using ADI’s Sensinel CPM Intelligent Algorithms in the cloud.
“Early detection of physiological changes is critical for clinicians to prevent a heart failure hospitalisation,” said Dr. Sean Pinney, Chief of Cardiology at Mount Sinai Morningside in New York City. “ADI’s Sensinel CPM System is a highly accurate, reproducible, and reliable solution to help improve predictive care.”
“When managing chronic conditions like heart failure, it is critical to adjust treatment early to get the condition under control without the need for hospitalisation. Other existing non-invasive solutions are not specific enough to provide the data a clinician needs to be effective for early intervention,” said 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.”
ADI’s Sensinel CPM System is now commercially available.
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