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Home » Biotronik wins FDA clearance for cardiac monitor sensor

Biotronik wins FDA clearance for cardiac monitor sensor

December 16, 2020 By Nancy Crotti

The Biomonitor IIIm (Image courtesy of Biotronik)

Biotronik today announced FDA clearance of its Vital Data Sensor, designed to identify body temperature increases potentially associated with fever, as part of its new Biomonitor IIIm injectable cardiac monitor (ICM).

Biomonitor IIIm contains integrated sensors designed to measure patient activity, heart rate and body temperature. The new sensor gives physicians access to daily reports on body temperature and cardiac arrhythmia, enabling them to monitor patients for warning signs at home.

“Vital data trends help support the diagnosis for a range of illnesses and, given the additional impact of the current pandemic on cardiac health, we have worked with urgency to advance Biomonitor IIIm’s unique sensor technology,” said Biotronik chief medical officer Dr. David Hayes in a news release. “Patients with cardiac conditions are at an increased risk for worse outcomes from many systemic illnesses, so closer monitoring of these patients may help manage potential symptoms associated with a febrile response, particularly if it can be done safely and remotely.”

Filed Under: 510(k), Cardiovascular, Featured, Food & Drug Administration (FDA), Patient Monitoring Tagged With: Biotronik, FDA

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