U.S. drug regulatory agency clears use of new injectable cardiac monitor sensor that also measures body temperature
Medical professionals will now have an additional weapon for diagnosing and preventing heart disease. The U.S. Food and Drug Administration, a state agency that oversees food and drug regulations, has approved the use of Biomonitor IIIm. The new sensor is manufactured by Biotronik, a Berlin-based multinational company specializing in equipment for cardiac diagnosis, treatment and therapeutic support. The sensor is applied under the patient’s skin near the heart and monitors vital data, including temperature and heart rate, moment by moment.
The first case using BIOMONITOR IIIm in the United States was performed by Dr. Luigi Di Biase. “The patient is at high risk for infection during this global pandemic due to underlying conditions. It is comforting for me and my patients knowing that we will be able to monitor for early signs of potential life-threatening cardiac arrhythmias and infections for up to 5.5 years. Coupled with the workflow advantages, this device is a step forward for injectable cardiac monitors”, said Di Biase, section head of Electrophysiology, Director of Arrhythmia Services at Montefiore Health System.
The reliability of the Biomonitor IIIm is assured by the battery life of up to 5.5 years. The durability provides long-term monitoring of the patient’s chronic cardiac condition. The device has a design that facilitates the insertion procedure in a single step by making a small incision. The accuracy of measurements equals the quality of the best external classical ECG. Biomonitor IIIm interfaces with BIOTRONIK Home Monitoring and provides 98% confidence in data transmission, simplifying and speeding up clinical device management.
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