FDA Clears BodyGuardian for Market

Developed by Preventice and the Mayo Clinic, the system detects, records, and wirelessly transmits physiological data to support remote monitoring of nonlethal cardiac arrhythmias in ambulatory patients.

Preventice Inc., a leading developer of mobile health applications and remote monitoring systems, announced that the U.S. Food and Drug Administration (FDA) has given the company 510(k) clearance for its BodyGuardian Remote Monitoring System (RMS).

Developed in collaboration with Mayo Clinic, the BodyGuardian System uses sophisticated algorithms to support remote monitoring for individuals with cardiac arrhythmias. The BodyGuardian System will allow 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. Patient data can then be transmitted to physicians via mobile phone technology. Remote patient monitoring can create a constant connection between patients and their care teams.

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, the BodyGuardian RMS will be prescribed by a physician or other qualified health care professional when diagnostic and post-procedure monitoring is needed. The company anticipates commercial availability of the BodyGuardian RMS by the end of 2012.

We are thrilled that the FDA has provided clearance for the BodyGuardian RMS enabling Preventice to bring to market a real-time, remote connection between physicians and patients,” said Jon Otterstatter, co-founder, president and CEO of Preventice.
Our vision at Preventice has been to maximize this industry-leading collaboration into a solution that enables health care providers to extend and improve care for their patients, where they live.

The use of wireless monitoring is rapidly increasing. According to a recent research study from Berg Insight, an estimated 2.2 million patients worldwide are already using this type of technology. Berg’s industry analysts anticipate the number of patient connections facilitated by wireless monitoring will reach 4.9 million by 2016. In addition, Technavio estimates the global patient monitoring market will reach $9.3 billion by 2014.

The BodyGuardian Remote Monitoring System will allow patients to benefit from Mayo expertise wherever they are in the world. The development of this solution has been a team effort, involving Preventice technology experts, Mayo physicians, nurses, engineers and technical staff—all exemplifying Mayo Clinic’s multidisciplinary team culture,” said Dr. Charles Bruce, a consultant in cardiovascular diseases and internal medicine at Mayo Clinic.

“This platform has the potential to positively impact health-care outcomes. Demonstrating effectiveness and exploring new models of health care delivery will be an immediate priority.”

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

Mayo Clinic and Drs. Charles Bruce, Paul Friedman, Virend Somers, and Mr. Kevin Bennet, all of Mayo Clinic, have a financial interest in this technology. Revenue Mayo Clinic receives will be used to advance education and research.

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