Minneapolis-based Preventice announced this week that the FDA had cleared its remote monitoring device for patients with cardiac arrhythmias, the BodyGuardian Remote Monitoring System, with a 510(k) clearance. Preventice developed the system with its partner Mayo Clinic and licensed technology from Proteus Biomedical's partner Avery Dennison for the peel-and-stick sensor.
BodyGuardian is a small body sensor that attaches to the patient's chest and tracks ECG, heart rate, respiration rate, and activity level. According to the 510(k) clearance document, the system continuously records, stores, and periodically transmits the physiological data for up to 30 days at a time. It "detects and monitors non-lethal cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional," according to the filing.
Preventice used Corventis' Avivo patient monitoring system as its predicate device for its FDA clearance.
Here's how the company describes BodyGuardian: "Preventice has licensed the remote monitoring algorithms for the BodyGuardian Remote Monitoring System from Mayo Clinic. The BodyGuardian System detects, records and wirelessly transmits physiological data to support remote monitoring of non-lethal, cardiac arrhythmias in ambulatory patients. Data is transmitted to the Preventice mHealth platform, where it can be stored for up to 30 days at a time. The BodyGuardian sensor adheres to the patient’s skin and is smaller than a cell phone, giving patients complete mobility and freedom to go about their normal lives without restriction. Physicians and medical professionals can securely view the captured medical information anytime, any place on devices such as the iPad, or online. Physicians can retrieve patient data and reports, or choose to receive alerts based on changes in select biometrics."
According to the FDA document, the companion iPad app for the device appears to be called PatientCare for iPad, but an app is already available by that name in Apple's AppStore from a different company offering a $1.99 EHR app.
Preventice plans to begin marketing BodyGuardian to hospitals and clinics and expects it to be commercially available by the end of the year.
More in the press release below:
PRESS RELEASE: MINNEAPOLIS (Sept. 10, 2012) —PreventiceTM, Inc., a leading developer of mobile health applications and remote monitoring systems, announced today 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.
About BodyGuardian
Preventice has licensed the remote monitoring algorithms for the BodyGuardian Remote Monitoring System from Mayo Clinic. The BodyGuardian System detects, records and wirelessly transmits physiological data to support remote monitoring of non-lethal, cardiac arrhythmias in ambulatory patients. Data is transmitted to the Preventice mHealth platform, where it can be stored for up to 30 days at a time. The BodyGuardian sensor adheres to the patient’s skin and is smaller than a cell phone, giving patients complete mobility and freedom to go about their normal lives without restriction. Physicians and medical professionals can securely view the captured medical information anytime, any place on devices such as the iPad®, or online. Physicians can retrieve patient data and reports, or choose to receive alerts based on changes in select biometrics.
About Preventice
Preventice, a leading developer of mobile health applications and remote monitoring systems, aims to engage patients with their care plans and close the patient engagement gap--the half trillion dollar cost created by patients failing to follow individual care plans. Technology from Preventice creates a continuous connection and exchange of data between health care providers, life science companies and patients. Current applications from Preventice address high-cost and chronic conditions and health management opportunities, including prescription medication management, cardiac care, sleep apnea, diabetes management, and migraine headaches. Preventice is headquartered in Minneapolis, with offices in Rochester, Minn., and Fargo, N.D. For more information, visit www.preventice.com.
About Mayo Clinic
Mayo Clinic is a nonprofit worldwide leader in medical care, research and education for people from all walks of life. For more information, visit www.mayoclinic.com and www.mayoclinic.org/news.
