German firm Biotronik has received FDA clearance for an injectable cardiac sensor that identifies body temperature increases potentially associated with fever.

As part of the Biomonitor IIIm injectable cardiac monitor, it means physicians will now have access to daily reports on vital data, including body temperature and cardiac arrhythmia data, to help them monitor patient health and their treatment remotely.

Biomonitor IIIm contains integrated sensor technologies designed to measure patient activity, heart rate and body temperature. The relationship between these vital signs and health conditions is well-documented, particularly fever, which leads to increases in mean and resting heart rates and possible decreases in activity levels.

Its battery longevity means 5.5 years of continuous monitoring, providing long-term monitoring of chronic cardiac conditions.

The first US case using Biomonitor IIIm was performed by Luigi Di Biase, section head of electrophysiology at Montefiore Health System in New York.

“The patient is at high risk for infection during this global pandemic due to underlying conditions,” said Di Biase. “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.”

This integrated sensor enables physicians to stay connected with cardiac patients and proactively monitor them for warning signs at home, preserving capacity in hospitals for the sickest patients. This can potentially provide earlier detection while helping to streamline remote patient management.

“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 David Hayes, chief medical officer of Biotronik. “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.”

Biomonitor devices have a design that facilitates a one-step injection procedure. They deliver detection performance and signal fidelity comparable with gold-standard 12-lead ECG recordings. In addition, the performance ensures 98 per cent daily transmission success for streamlined clinical device management.

Biotronik is a medical device company that has been developing cardiovascular and endovascular products for more than 50 years. It is headquartered in Berlin, Germany, and represented in more than 100 countries.