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ADI announces that the Sensinel by Analog Devices Cardiopulmonary Management (CPM) system has obtained FDA 510 (k) certification and is officially launched in the United States

Post on Jan 01,1970

Analog Devices, Inc. (Nasdaq: ADI) announced that ADI's Sensinel Cardiopulmonary Management (CPM) system has obtained FDA 510 (k) certification and is officially launched. This compact wearable device is a non-invasive remote management system that can monitor cardiovascular physiological data for the management of chronic diseases such as heart failure. This is the first FDA certification obtained by ADI since its establishment 59 years ago.

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Patrick O'Doherty, Senior Vice President of ADI Digital Healthcare, said, "Since its establishment, ADI has been committed to accelerating breakthrough innovation and enriching people's lives with innovative products.". By combining our advanced technology in wearable vital sign monitoring and signal processing with algorithms designed under the guidance of cardiac experts, we have successfully developed the Sensinel CPM system, which can accurately evaluate the daily health status of patients with congestive heart failure. This service oriented innovative product not only has the potential to open up billions of dollars in new markets for ADI, but also can improve patient care effectiveness, optimize clinical doctors' workflows, and effectively reduce medical costs

Currently, over 6 million Americans suffer from heart failure, and it is expected that this number will increase to nearly 8 million by 2030. Currently, heart failure brings about $30 billion in medical expenses to Americans annually, and it is expected that by 2030, this cost will climb to nearly $70 billion, of which approximately 80% is hospitalization expenses. Previous solutions for monitoring similar health indicators have been proven to reduce hospitalization rates. However, these solutions are often either invasive or the monitored data is not precise and specific enough to have a significant impact in clinical practice. Accurate and timely data is crucial as it allows medical teams to predict and intervene in advance, thereby avoiding patients from paying expensive hospitalization costs due to heart failure.

The Sensinel CPM system is a next-generation solution for managing heart and lung diseases such as heart failure. It has a series of physiological indicator monitoring functions, which can assist medical teams in remotely managing chronic diseases earlier, more effectively, and more accurately. Patients can wear ADI Sensinel CPM wearable devices on their own, and only need to wear them for three to five minutes in a home care environment. After wearing, the device will collect the patient's cardiopulmonary health data, and automatically upload the data to ADI's Sensinel CPM cloud platform through the cellular link (without the patient's own Internet connection), and use ADI's Sensinel CPM intelligent algorithm for further analysis and processing in the cloud.

Dr. Sean Pinney, Director of Cardiology at Mount Sinai Morningside Hospital in New York City, USA, said, "For clinicians, early detection of a patient's physiological changes is key to avoiding hospitalization for heart failure. ADI's Sensinel CPM system is a highly accurate, repeatable, and reliable solution that helps improve our predictability of disease progression and better care for patients."

Dr. Venu Gopinathan, Academician and Director of Medical Product Management at ADI, said, "It is very important to adjust treatment measures early in managing chronic diseases such as heart failure to control the condition and avoid hospitalization. Currently, other non-invasive solutions cannot provide sufficient specific data to meet the needs of clinical doctors for effective early intervention.". Our newly developed cardiopulmonary management system can seamlessly integrate into nursing workflows, helping medical teams make accurate clinical decisions as early as possible by measuring multiple physiological indicators, while avoiding the problem of information overload.

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