FDA clears remote cardiac arrhythmia monitor

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Preventice, a developer of mobile health applications and remote monitoring systems, has received FDA 510(k) clearance for its BodyGuardian remote monitoring system (RMS). Developed in collaboration with Mayo Clinic in Rochester, Minn., the BodyGuardian System uses algorithms to support remote monitoring for individuals with cardiac arrhythmias. The BodyGuardian System seeks to monitor biometrics outside of the clinical setting. A small body sensor attached to the patient’s chest collects important data, including the patient’s ECG, heart rate, respiration rate and activity level. Patient data is then transmitted to physicians via mobile phone technology, according to the Minneapolis-based company. 

The FDA clearance allows Preventice to market and sell BodyGuardian to hospitals and clinics for use in detecting and monitoring non-lethal cardiac arrhythmias for ambulatory patients. Although not yet commercially available, Preventice said the BodyGuardian RMS will be prescribed by a physician or other qualified healthcare professionals when diagnostic and post-procedure monitoring is needed. The company anticipates commercial availability of the BodyGuardian RMS by the end of this year.

BodyGuardian RMS is supported by the Preventice Care Platform, a cloud-based mHealth platform that collects data from devices and delivers information to medical monitoring professionals.

Mayo Clinic and Charles J. Bruce, MD; Paul A. Friedman, MD; Virend K. Somers, MD, PhD; and Kevin Bennet, MBA, all of Mayo, have a financial interest in this technology.