ADI Launches Sensinel CPM System with FDA Clearance to manage chronic heart deseases
Date: 09/03/2024
Analog Devices has received the U.S. Food and Drug Administration (FDA) clearance to launch its Sensinel Cardiopulmonary Management (CPM) System. This innovative wearable device offers a non-invasive and remote solution for capturing crucial cardiopulmonary measurements, particularly for chronic conditions like heart failure. Notably, this marks ADI's first FDA clearance in its distinguished 59-year history.
Addressing Chronic Disease Burden: With over 6 million Americans currently living with heart failure and rising healthcare costs projected to reach nearly $70 billion by 2030, there's an urgent need for effective management solutions. The Sensinel CPM System aims to mitigate these challenges by providing early detection and remote monitoring capabilities, potentially reducing costly hospitalizations.
Non-Invasive Wearable Design: The Sensinel CPM Wearable offers a user-friendly experience, requiring patients to wear it for just three to five minutes in a home care setting. Despite its compact size, the device captures comprehensive cardiopulmonary data, offering a convenient and non-intrusive solution for patients.
Cloud-Based Data Analysis: Utilizing ADI's Sensinel CPM Cloud Platform and Intelligent Algorithms, captured data is securely uploaded and analyzed in real-time. This cloud-based approach enables care teams to access precise physiological indicators remotely, empowering them to make informed decisions for proactive disease management.
By combining non-invasive wearable technology with sophisticated cloud-based analytics, ADI is delivering solutions for remote patient monitoring and early intervention strategies. As adoption of this innovative solution grows, it holds the promise of transforming the landscape of cardiopulmonary care, ultimately leading to better outcomes and reduced healthcare costs.
“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,” 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.”
“Early detection of physiological changes is critical for clinicians to prevent a heart failure hospitalization,” 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.”
“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.”
ADI’s Sensinel CPM System is now commercially available. For more information, visit https://sensinel.analog.com.
