FDA Clears New Remote Patient Monitoring Wearable

With the rise of chronic diseases, more and more health tech companies are developing vital sign monitors to improve chronic care. ChroniSense Medical Ltd, a portfolio company of Rainbow Medical working to improve chronic disease management, has recently received FDA’s 510(k) clearance for Polso, a wrist band for remote patient monitoring. The band can take various physiologic measures to help optimize chronic care. 

Polso tracks eight parameters, including pulse oximetry, pulse rate, blood pressure, respiratory rate, ECG, temperature, heart rate variability, and activity levels. However, the FDA clearance is only for three of those parameters: pulse oximetry, pulse rate, and respiration rate.

The embedded sensors in the wrist band and quick analytics help the user gain insights on important vital signs for better chronic care. The device uses signals from the radial artery to extract critical health data. It is specifically helpful in cardiovascular conditions, respiratory diseases, comorbid conditions like renal disease and heart failure, clinical trials where patient tracking is required, and long-term care after the discharge of hospitalized patients. 

Currently, every 6 out of 10 adults in the US have some chronic condition. It costs over $1.1 trillion to manage these conditions every year. An easy-to-use remote patient monitoring gadget could help prevent emergency visits and reduce the overall cost of managing chronic diseases. 

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