Sensible Medical Innovations Receives FDA 510K Clearance for its Non-Invasive Thoracic Fluid Status Monitor

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Sensible Medical Innovations Ltd., is proud to announce that it received clearance from the U.S. Food and Drug administration (FDA) for its non-invasive thoracic fluid status monitor.

Sensible Medical Innovations Ltd., is proud to announce that it received clearance from the U.S. Food and Drug administration (FDA) for its non-invasive thoracic fluid status monitor. The Sensible product is intended for monitoring and management of patients with fluid management problems, including patients living with heart failure, patients taking diuretic medication or patients recovering from a coronary artery disease related event. The Sensible product is intended to be used by qualified health care practitioners and by patients, under the direction of a physician, in hospitals, hospital-type facilities and home environment.

The Sensible product, powered by ReDS™ medical radar technology, can be used by patients in the comfort of their home, for a short daily measurement that takes only 90 seconds. Patients measure their lung fluid content and the results may be automatically uploaded to a secure cloud application for a healthcare professional to review and act upon, based on his discretion.

Lung fluid management problems, including heart failure (HF), are a leading cause for hospital admissions for the elderly. Millions of patients suffering from fluid management problems are repeatedly admitted to the hospital due to recurring symptoms, resulting in one of the top expenditure items for hospitals and the US healthcare system altogether. Unfortunately, healthcare professionals have very limited tools to evaluate the status of lung congestion to assist in management. The Sensible non-invasive solution is designed to enable patients and healthcare professionals to monitor patients’ lung fluid directly and in a non-invasive manner.

“With ReDS technology we aim to improve the quality of life of millions of patients with fluid management problems worldwide. Our goal is to enable care of patients in the home setting. The ReDS-HF clinical outcome study to be presented in the upcoming HFSA conference in September suggests promising results that prove reduction of hospital readmissions. While further clinical data is required, we believe the technology is well positioned to be a game changer in the market,” says Amir Ronen, CEO of Sensible Medical Innovations. Prof. Avi Ludomirski, Chairman of the Board of Sensible Medical Innovations commented that, “Receiving 510K clearance is a major milestone for the company. We have seen very successful results using the Sensible solution in clinical trials and now, with the receipt of clearance from the FDA, we are eager to see this solution in the US market.”

About Sensible Medical Innovations Ltd.

Sensible Medical Innovations Ltd. has developed a wearable thoracic fluid status monitor for non-invasive measurement and monitoring of lung fluid, for patients with fluid management problems such as patients living with heart failure, taking diuretic medication or recovering from a coronary artery disease related event. The company, headquartered in Kfar Neter, Israel was founded in 2007

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Mrs. Yael Kwiat Livne
Sensible Medical Innovations Ltd,
+972 544457445
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