Preventice has declared that it has received 510(k) clearance for its BodyGuardian Remote Monitoring System (RMS) from the U.S. Food and Drug Administration (FDA).
Jointly developed with Mayo Clinic, the BodyGuardian System is based on advanced algorithms that enable remote monitoring of patients with cardiac arrhythmias. Using BodyGuardian System, medical experts can track key biometrics when the patient is external to the clinical setting. By fastening a small body sensor onto the patient's chest, key data such as the patient's activity level, ECG, heart rate, and respiration rate can be collected. Using mobile phone technology, patient data can be conveyed to physicians. Remote patient monitoring strengthens the bond between patients and their medical team.
Following the achievement of FDA clearance, Preventice can commercialize BodyGuardian to clinics, hospitals and medical centers for adoption to detect and track non-lethal cardiac arrhythmias in ambulatory patients. The BodyGuardian RMS is yet to be commercially available but can be recommended by qualified physicians for specific diagnostic and post-procedure monitoring. The BodyGuardian RMS will be commercially available by 2012 end.
There is rapid implementation of wireless monitoring. A recent research study from Berg Insight states that around 2.2 M global patients have been estimated to be using this type of technology. Berg's industry analysts hope increase in the adoption of wireless monitoring to attain 4.9 M by 2016. Furthermore, Technavio anticipates global patient monitoring market to reach $9.3 B by 2014.
BodyGuardian RMS is built on the Preventice Care Platform, which is a cloud-based mHealth platform that is capable of gathering real-time data from devices and providing information to medical monitoring experts worldwide.