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Medical Devices / Submissions and Approvals

FDA Clears Wearable Monitor for COPD Patients

April 4, 2019
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The FDA granted Spry Health 510(k) clearance for its Loop System, a remote monitor designed to help manage chronic obstructive pulmonary disease (COPD) and other chronic conditions.

The continuous monitoring device is worn around the wrist, to collect the wearer’s heart rate, blood pressure, respiration and pulse-oximetry. The system requires no configuration by the patient.

The collected data is automatically analyzed for clinically relevant signs of condition deterioration, which are then displayed to healthcare providers on a dashboard included with the product.

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