BIOMONITOR III Injectable Cardiac Monitor Wins FDA Clearance

Having unveiled their BIOMONITOR III a couple of weeks ago, BIOTRONIK just won FDA clearance for the device. The new version of the BIOMONITOR injectable cardiac monitor is less than half the size of the previous model, but it offers the ability to provide a substantially improved signal quality.

Designed to be injected under the skin, where it can reside for up to four years while continuously monitoring cardiac signals, it can help detect cardiac arrhythmias and unexplained syncopes, or loss of consciousness. Patients with atrial fibrillation will benefit thanks to their cardiologists having an easier time spotting signs of this common malady.

The new monitor can significantly increase signal amplitudes and the visibility of p-waves compared with the previous generation of the device, helping cardiologists to better spot arrhythmias. It is able to save the most clinically important recordings from being overwritten by, and all data can be easily transmitted to one’s doctor via the BIOTRONIK Home Monitoring system.

“BIOMONITOR ICMs have a proven track record for exceptional signal quality,” said Dr. Raul Weiss, Columbus, Ohio. “BIOMONITOR III expands the existing diagnostic utility of these devices while simplifying the procedure. BIOMONITOR III is an exceedingly small device with market-leading four year longevity. When physicians are not burdened by poor signal quality, clinically irrelevant data, inaccurate, or worse, missed detections – more time can be devoted to ensuring a timely and accurate diagnosis.”

Flashbacks: BIOTRONIK Releases BioMonitor 2 Wireless Subcutaneous ECG System; BIOTRONIK’s BioMonitor 2 Implantable Wireless ECG Recorder Approved in Europe; BIOTRONIK BioMonitor 2 Wireless Implantable ECG Recorder FDA Approved; BIOTRONIK Releases BIOMONITOR III Injectable Cardiac Monitor

Via: BIOTRONIK

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