Remote patient monitoring is becoming an increasingly important part of the clinician’s toolkit. One platform, BodyGuardian, combines a wearable sensor, a modified Android-based Samsung smartphone, and advanced monitoring algorithms developed at the Mayo Clinic to help improve detection of arrhythmia. I recently had the pleasure of participating in a live demo of the Preventice (@preventice) BodyGuardian Remote Patient Monitoring System (BodyGuardian RMS).
The company has recently begun clinical trials of the system in the US and EU to quantify the impact of the BodyGuardian RMS on clinical care delivery. The trials are being conducted with the Mayo Clinic in Rochester, MN, Sanpietro Clinic in Milan, Italy, and Bordeaux Hospital University Center in Bordeaux, France, with the objective to analyze and quantify the clinical impact of advanced monitoring capabilities such as remote transmission of ECG signals and on-demand event transmission as well as the centralized analysis of significant amounts of data.
“We’re quickly approaching two significant milestones for the BodyGuardian RMS with the commercial availability of the system in early spring and robust clinical trial activity here in the United States and abroad. The clinical trial volume is a direct indicator of significant interest in BodyGuardian by early adopters and it demonstrates their belief that Preventice is poised to facilitate change in health care,” said Jon Otterstatter, co-founder, president and CEO of Preventice. “We’re confident that the BodyGuardian has the potential to become a key element of integrating care management and behavior change with any health care provider’s digital health delivery program. BodyGuardian RMS supports efforts to increase the efficiency and effectiveness of chronic disease management while empowering patients to take a more proactive role in their health care.”
Preventice received FDA 510K clearance in August 2012, enabling the company to market and sell BodyGuardian RMS to hospitals and clinics for use in detecting and monitoring non-lethal cardiac arrhythmias for ambulatory patients. Though the device is not yet commercially available, it will ultimately be prescribed by a physician or other qualified health care professional when diagnostic and post-procedure monitoring is needed.
Preventice developed the BodyGuardian RMS by essentially piecing together individual technologies developed by leading companies to create a platform for delivering remote patient monitoring services. The three core components of the BodyGuardian system are the wearable sensor, the algorithms which give the sensor its advanced detection capability, and the smartphone device used by the sensor to transmit data to a secure, cloud-based server.
The wearable sensor is enabled by hardware and software technology developed by STMicroelectronics and includes sophisticated MEMS, low-power STM32 microcontrollers, and analog components combined with advanced ST-proprietary algorithms. The clinical algorithms utilized by the device were developed over the last 10-years by doctors at the Mayo Clinic to support remote monitoring of individuals with cardiac arrhythmias. Finally, Samsung Mobile will customize the Galaxy S II smartphone for use in the BodyGuardian RMS by creating a dedicated mobile environment that will ensure a secure, reliable wireless connection for the transmission of biometric data.
“Remote patient monitoring will significantly change the way patients with heart disease and a variety of other chronic conditions experience the health care system, but only if we’re able to provide solutions that meet the strictest of standards for patient protection and clinical performance,” said Jon Otterstatter, co-founder, president and CEO of Preventice. “By collaborating with Samsung, we are able to create a dedicated mobile environment that brings sophisticated, secure and reliable, remote patient monitoring to patients where they live, work and play.”
I took the image below with my iPhone of the Samsung Galaxy II device I was given by the Preventice team when I was conducting my live ambulatory demo of the BodyGuardian RMS. The Android device was totally custom and wouldn’t even let me navigate from the screen seen below, which made it easier to simply put in my pocket and forget about. I actually couldn’t even view the ECG itself on my screen except for the first few moments following initial connection between the sensor on my chest and the phone.
It shows my resting heart rate, as well as the quality of the signal and the last time my data was transmitted to the smartphone, as well as the last time I personally initiated a physician alert, which instantly transmits my data for the minute prior to me pushing the button and the minute following. The following image is an actual recording of my ECG following the initiation of an event alert. Clearly I was not actually experiencing an event, but if I had been the physician would have seen that very clearly within moments of the occurrence.
The device was very discrete and not uncomfortable to wear on my skin while walking around the conference for about four hours, though due to the industrial strength adhesive used to apply it to my chest I had to do a bit of grooming to prepare.