Analog Devices Receives FDA 510(k) Clearance and Launches Sensinel™ Cardiopulmonary Management (CPM) System

Beijing, China—March 7, 2024—Analog Devices, Inc. (Nasdaq: ADI) announced that its Sensinel™ Cardiopulmonary Management (CPM) System has received U.S. Food and Drug Administration (FDA) 510(k) clearance and is now commercially available. This compact wearable device is a non-invasive remote management system capable of monitoring cardiopulmonary physiological data for the management of chronic conditions such as heart failure. This marks the first FDA clearance obtained by ADI in its 59-year history.

Patrick O'Doherty, Senior Vice President of Digital Health at ADI“Since its inception, Analog Devices (ADI) has been committed to accelerating breakthrough innovations and enriching people’s lives through innovative products. By integrating our advanced technologies in wearable vital signs monitoring and signal processing with algorithms designed under the guidance of cardiologists, we have successfully developed the Sensinel CPM system, which accurately assesses the daily health status of patients with congestive heart failure. This service-oriented innovative product not only has the potential to open up a multi-billion-dollar new market for ADI, but also enhances patient care outcomes, optimizes clinicians’ workflows, and effectively reduces healthcare costs.”

Currently, more than 6 million Americans suffer from heart failure, and this number is projected to rise to nearly 8 million by 2030.¹ At present, heart failure incurs approximately $30 billion in annual healthcare costs for Americans, a figure expected to climb to nearly $70 billion by 2030,¹ with roughly 80% of these expenses attributed to hospitalization.¹ Previous solutions introduced to monitor similar health indicators have been shown to reduce hospitalization rates. However, these solutions are often either invasive or lack the precision and specificity required to make a significant clinical impact. Accurate and timely data are crucial, as they enable healthcare teams to predict and intervene early, thereby sparing patients the high costs associated with hospitalization for heart failure.

The Sensinel CPM system is a next-generation solution for the management of cardiopulmonary diseases such as heart failure. Equipped with a range of physiological monitoring capabilities, it enables healthcare teams to remotely manage chronic conditions more early, effectively, and precisely. Patients can self-administer the ADI Sensinel CPM wearable device, which requires only three to five minutes of wear time in a home care setting. Once worn, the device collects cardiopulmonary health data from the patient and automatically uploads it via cellular connectivity to the ADI Sensinel CPM cloud platform (eliminating the need for patients to have their own internet connection). The data then undergoes further analysis and processing in the cloud using ADI’s Sensinel CPM intelligent algorithms.

Dr. Sean Pinney, Director of the Division of Cardiology at Mount Sinai Morningside in New York City“Early detection of physiological changes in patients is key for clinicians to prevent hospitalizations due to heart failure. Analog Devices’ Sensitel CPM system is a highly accurate, reproducible, and reliable solution that enhances our ability to anticipate disease progression, thereby enabling better patient care.”

Dr. Venu Gopinathan, ADI Fellow and Director of Medical Product Management at ADI“He stated, ‘In the management of chronic diseases such as heart failure, it is crucial to adjust treatment measures early to control the condition and avoid hospitalization. Currently, some other non-invasive solutions fail to provide sufficiently specific data, thus unable to meet clinicians’ needs for effective early intervention. Our newly developed cardiopulmonary management system can seamlessly integrate into care workflows, assisting healthcare teams in making accurate clinical decisions at an early stage through multi-parameter physiological measurements, while avoiding the issue of information overload.’”

Analog Devices, Inc.’s Sensinel CPM System Is Now Available.

Senseless by Analog Devices is a brand-new wearable medical health series, designed to fundamentally change the management of chronic diseases and enable patients to improve their quality of life in an affordable way. The first product in this series, the Sensinel CPM system, is a non-invasive home care solution that monitors cardiopulmonary physiological data for the management of chronic conditions such as heart failure. Analog Devices, Inc., which launched the Sensinel series, is a global leading semiconductor company with over 50 years of experience in the healthcare industry. It specializes in technologies such as detection, measurement, computation, connectivity, and power supply, driving breakthrough innovations that accelerate human progress and make our lives and world richer and more colorful.

Analog Devices, Inc. (NASDAQ: ADI) is a global leader in the semiconductor industry, dedicated to bridging the physical and digital worlds to enable breakthrough innovations at the intelligent edge. By providing solutions that integrate analog, digital, and software technologies, ADI drives continuous advancement in sectors such as digital factories, automotive, and digital healthcare, addresses the challenges of climate change, and establishes reliable connectivity between people and everything around them. With fiscal year 2023 revenue exceeding $12 billion and approximately 26,000 employees worldwide, ADI partners with 125,000 customers globally to help innovators transcend all possibilities.

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References

1. American Heart Association, “Understand your risk for heart failure,” American Heart Association website, published May 9, 2017, updated June 13, 2023, accessed March 5, 2024. https://www.heart.org/en/health-topics/heart-failure/causes-and-risks-for-heart-failure/understand-your-risk-for-heart-failure