US-based Preventice has obtained CE Mark from the European Commission for its BodyGuardian remote monitoring system for use in detecting and monitoring non-lethal cardiac arrhythmias for ambulatory patients.
Preventice has developed the BodyGuardian system in collaboration with Mayo Clinic.
Supported by the Preventice Care Platform, the BodyGuardian system utilizes sophisticated algorithms to support remote monitoring for individuals with cardiac arrhythmias.
Physicians can monitor key biometrics outside the clinical setting by using the BodyGuardian system.
ECG, heart rate, respiration rate and activity level will be collected by a small body sensor attached to the patient’s chest and this data can then be transmitted to physicians through mobile phone technology.
Preventice co-founder president and CEO Jon Otterstatter noted 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," Otterstatter added.
In August 2012, Preventice received 510(k) approval from the US Food and Drug Administration to market the BodyGuardian system in the US.
The company also received ISO 13485: 2003 certification for meeting quality and manufacturing standards.