As announced at the December mHealth Summit, Preventice’s BodyGuardian RMS will be commercially available to hospitals, clinics, and testing facilities in the U.S. and Europe in 2013. Preventice received 510(k) clearance from FDA in August enabling the company to market and sell the remote monitoring systems to hospitals and clinics to wirelessly transmit physiological data on non-lethal, cardiac arrhythmias in ambulatory patients. The data is transmitted to the mhealth platform where it can be stored for 30 days at a time.
Meanwhile, clinical trials are underway to study the impact of the monitoring system on clinical care delivery. Specifically, trials are being conducted with Mayo Clinic in Rochester, Minnesota, Sanpietro Clinic in Milan Italy, and Bordeaux Hospital University Center in Bordeaux France. The trials are being conducted to analyze and quantify the clinical impact of advanced monitoring involving the remote transmission of ECG signals, on-demand event transmission, and the ability to analyze significant amounts of data.
Specifically, the clinical trials are studying:
- Post-surgical cardiac patients to evaluate how monitoring cardiac rhythms remotely influences all phases of hospital recovery
- Patients with congestive heart failure to determine early warning of decompensated heart failure and the ability to deliver more timely interventions to prevent more serious and expensive complication
- How to do 24/7 continuous monitoring of non-surgical, infrequently symptomatic patients as they go about their daily lives with the objective of detecting potential arrhythmias by tracking ECG, respiratory rate, and activity
Jon Otterstatter, Co-Founder, President and CEO of Preventice notes that a new clinical trial to study the use of remote monitoring to manage default hospital admissions for cardiac patients is planned for 2013 at Mayo Clinic.
Also, according to Michael Emerson, Senior Vice President of Marketing, “In addition to their collaboration with the Mayo Clinic which developed the algorithms on which the technology is based, Preventice is also working with STMicroelectronics and Samsung Electronics to bring the BodyGuardian to market.”
Preventice is located in Minneapolis with offices in Rochester, Minnesota and Fargo North Dakota. For more information, go to www.preventice.com.