ADI announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is officially launching the Sensinel cardiopulmonary management (CPM) system to the market. This innovative wearable device is designed to remotely monitor cardiopulmonary health and is especially suited for the daily management of chronic conditions such as heart failure. It is worth noting that this is the first time in its 59-year history that an ADI product has received FDA approval, and it is one of the few products that ADI has launched as a complete device, proving its expertise in the healthcare industry.
Patrick O’Doherty, senior vice president of digital health at ADI, said in a statement, “Since the company’s inception, ADI has been committed to improving people’s lives through innovative products and technologies. By combining our advanced wearable vital signs sensing and signal processing technologies with algorithms developed by cardiologists, we have successfully developed the Sensinel CPM system, which is capable of accurately monitoring the day-to-day health of congestive heart failure patients. This innovative product is not only expected to open up billions of dollars in new market opportunities for ADI, but also significantly improve patient care, streamline clinicians’ workflows, and reduce healthcare costs.”
Currently, more than 6 million people in the U.S. suffer from heart failure, and that number is expected to climb to nearly 8 million by 2030. Approximately 80 percent of the cost of treating heart failure is associated with hospitalization. While some solutions capable of monitoring similar parameters already exist on the market, they are often invasive or do not provide data that is sensitive and specific enough to have a meaningful clinical impact. ADI’s Sensinel CPM system, on the other hand, overcomes these limitations and provides a next-generation solution for monitoring and treating cardiopulmonary disease.
Equipped with a comprehensive suite of physiological metrics to monitor, the system helps healthcare teams manage the health of chronically ill patients earlier, remotely, and more accurately. Patients can capture data about their cardiorespiratory health by simply wearing ADI’s Sensinel CPM wearable device for three to five minutes on their own in a home care setting. This data is then automatically uploaded via a cellular link to ADI’s Sensinel CPM cloud platform for further analysis without requiring the patient to provide an additional Internet connection.
Commenting on this, Dr. Sean Pinney, Chief of Cardiology at Mount Sinai Morningside Hospital in New York City, said, “Early detection of physiological changes is critical for clinicians to prevent hospitalizations for heart failure, and ADI’s Sensinel CPM system is a highly accurate, reproducible, and reliable solution to help improve predictive care outcomes.”
Dr Venu Gopinathan, ADI Fellow and Managing Director of Medical Products, also noted, “When treating chronic conditions such as heart failure, it is critical to make early adjustments to treatment regimens to manage progression, which can prevent unnecessary hospitalizations. Our new cardiopulmonary system is designed to fit seamlessly into existing care workflows by performing a variety of physiological measurements to help care teams make earlier clinical decisions while avoiding information overload.”
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