Minneapolis-based Preventice announced the commercial launch of its first hardware product: the BodyGuardian Remote Monitoring System. The device, a small sensor attached to the body via a peel-and-stick patch, received FDA 510(k) clearance in August 2012. BodyGaurdian RMS uses an algorithm developed by the Mayo Clinic, sensor technology from STMicroelectronics, and wireless technology from Samsung.
The company also suggested to MobiHealthNews that at least one additional hardware product is in the works from the company. The second device will leverage a developer's agreement with Avery Dennison for Proteus Digital Health's disposable patch technology. That's the same patch technology that powers BodyMedia's possibly forthcoming VUE patch.
"We understand that in this ambulatory market, different devices will serve different purposes according to length of stay and quality of signal, and our strategy is to have different offerings," Preventice Senior VP of Marketing Michael Emerson told MobiHealthNews.
The BodyGuardian RMS is for detecting and monitoring nonlethal cardiac arrhythmias in ambulatory patients. The company is not marketing it directly to consumers, since its FDA clearance is only for prescription use. Instead, Preventice will sell units to providers and organizations that work with providers. Emerson said the device qualifies for reimbursement under many health plans.
Patients using the system will receive a number of peel-and-stick patches, two sensor units, plus a dedicated smartphone with preloaded software. The patches are cleared to be worn for 30 days at a time, but Preventice recommends changing them more frequently. The devices are designed to be swapped out every morning and night, with the patient putting the device they're not wearing in a charging cradle. This allows the sensor to collect data for all but a few minutes each day. The patch is water-proof and the sensor is water-resistant.
"Most patients have reported that they lose track that they're wearing it after a few hours," Emerson said. "It really disappears from your conciousness. We really have had no issues with longterm wear. Unless you have a spandex shirt on you really don't even see it underneath a shirt or blouse."
The device collects data on ECG, heart rate, respiratory rate, and activity level. The data is transmitted over a cellular network that can be accessed on a doctor's mobile device or through a web portal. At the request of the hospital, that data can also be moved into an EHR, Emerson said.
The company has a number of customers lined up, according to Emerson, as well as some pilots and clinical trials set to launch. The Mayo Clinic will be running some pilots and will receive some of the devices as part of the ongoing agreement by which Preventice licensed the algorithm. Other trials will be run in Italy and France and will test the device with post-surgical cardiac patients, patients with congestive heart failure, and infrequently symptomatic patients.
Additionally, the company has a financial pilot in the works with an as-yet-undisclosed payor to establish whether the device delivers significant healthcare savings.