By a News Reporter-Staff News Editor at Clinical Trials Week -- Preventice(®), Inc., announced that it has received CE Mark certification for its BodyGuardian(®) Remote Monitoring System from the European Commission (see also Preventice, Inc.).
Developed in collaboration with Mayo Clinic, the BodyGuardian uses sophisticated algorithms to support remote monitoring for individuals with cardiac arrhythmias. The BodyGuardian allows physicians to monitor key biometrics outside 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 CE Mark states that the BodyGuardian has been assessed and meets the European Union's (EU) safety, health and environmental protection requirements for products that are marketed and sold in 28 EU market states and the EFTA countries of Iceland, Liechtenstein and Norway. Preventice received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in August 2012, enabling the mobile health solutions company to market BodyGuardian for use in detecting and monitoring non-lethal cardiac arrhythmias for ambulatory patients in the United States. The company also recently received ISO 13485: 2003 certification, which is a globally recognized standard that signals to customers, strategic partners and the broader industry that Preventice abides by the highest standards for quality and manufacturing.
"Interest in the BodyGuardian in the United States has been strong and steady since we began commercial sales earlier this year," said Jon Otterstatter, co-founder, president and CEO of Preventice. "We're extremely pleased to have received approval to bring BodyGuardian to healthcare providers and patients both here and in Europe. In fact, we already have a number of European clinical trials in development."
Otterstatter noted that use of remote monitoring technology in healthcare is already on the rise, and that Preventice was named as a leading resource for ECG remote monitoring in the most recent "Hype Cycle for Telemedicine, 2013," from Gartner Research. Gartner analysts noted the potential for remote monitoring technology to improve the patient experience, to address the looming shortage in healthcare workers, to reduce hospital readmissions and to positively impact healthcare trend.
"By earning CE Mark certification for BodyGuardian, the stage is set for patients to benefit from the BodyGuardian system wherever they are in the world. The development of this solution has been a team effort, involving Preventice technology experts, Mayo Clinic physicians, nurses, engineers and technical staff, and the sensor technology leaders at STMicroelectronics. All of these forces have been focused on using remote monitoring technology to change healthcare in a positive way, which is what gives systems like BodyGuardian the ability to improve outcomes, reduce costs, and better engage patients in their care," said Otterstatter.
BodyGuardian 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.
Keywords for this news article include: Technology, Preventice Inc., Clinical Trials and Studies.
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