FDA Clears Arrhythmia Monitoring System
Small body sensor transmits data to physicians via mobile-phone technology (Sept. 10)
Preventice, Inc. based in Minneapolis, Minn., announced on September 10 that the FDA has given the company 510(k) clearance for its BodyGuardian Remote Monitoring System (RMS).
Developed in collaboration with the Mayo Clinic, the BodyGuardian System uses algorithms to support remote monitoring for individuals with cardiac arrhythmias. The system allows physicians to monitor key biometrics outside of the clinical setting, while patients go about their daily lives. 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. The data can then be transmitted to physicians via mobile-phone technology.
The FDA clearance allows Preventice to market and sell BodyGuardian to hospitals and clinics for use in detecting and monitoring nonlethal cardiac arrhythmias for ambulatory patients. Although not yet commercially available, the BodyGuardian RMS will be prescribed by a physician or other qualified healthcare professional when diagnostic and post-procedure monitoring is needed.
Preventice anticipates commercial availability of the monitoring system by the end of 2012.
According to the company, the use of wireless monitoring is rapidly increasing. In a recent research study, an estimated 2.2 million patients worldwide were using this type of technology. Industry analysts anticipate the number of patient connections facilitated by wireless monitoring will reach 4.9 million by 2016.
Preventice has licensed the remote monitoring algorithms for the BodyGuardian RMS from the Mayo Clinic.
For more information, visit the Preventice, Inc. Web site.