Preventice announced today that its remote monitoring system for heart patients has received clearance from the U.S. Food and Drug Administration.
The BodyGuardian Remote Monitoring System can now be marketed and sold to hospitals and clinics for the detection and monitoring of non-lethal heartbeat irregularities. BodyGuardian allows physicians to monitor important biometrics while patients with cardiac arrhythmias go about daily life.
The m-health product uses a body sensor that adheres to the patient’s skin. The sensor, which is smaller than a cell phone, is attached to the chest to collect data such as the patient’s electrocardiogram, heart rate, respiration rate and activity level. The information can then be transmitted to doctors by mobile phone technology. Doctors can pull up information or choose to receive alerts based on changes in biometrics.
BodyGuardian relies on advanced algorithms licensed from the Mayo Clinic. The product will require a prescription and is expected to be used for diagnostic and post-procedure monitoring. Preventice expects that the m-health product will be commercially available by the end of this year.