Australian clinical activity tracker gets FDA clearance

By Jonah Comstock
10:26 am

ViMoveAustralian company dorsaVi has received FDA clearance for its ViMove sensor system. The sensor tracks movement as well as muscle activation, and is intended to be used in a clinical setting or with athletes in training.

Despite the preponderance of consumer fitness trackers, FDA-cleared devices for tracking movement in the clinical sphere are just starting to emerge, partly because of the emphasis on quantitative data in the Affordable Care Act to enable value-based care models. For instance, the StepWatch from modus health, which has been in use for years as a research device, announced a move to the clinical sphere just last week.

Similarly, ViMove has been in use in Melbourne, Australia since the early 2000s when it was developed by dorsaVi cofounders Andrew and Dan Ronchi as a hobby project. They incorporated the company in 2008, and received funding from Australian VC Starfish Ventures. That investment led to an Australian IPO, which gave the company funds to put toward international expansion. FDA clearance now allows the company to sell its technology in the United States. 

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The ViMove platform consists of four sensors embedded in two devices worn on the body. One contains an accelerometer, magnetometer, and gyroscope and tracks movement. The other is a diagnostic electromyography sensor that measures muscle activity. This allows the device to measure and record range of movement and muscle activity in the lower back, lumbar support, and other kinds of movement. The data is transmitted wirelessly to a computer, which automatically generates reports for patients and physicians to read.

"The benefit of this is the fact that physicians can do this assessment in their clinic," John Kowalczyk, dorsaVi's US President, told MobiHealthNews. "So, to a degree, it’s all the benefits of a biomechanic lab in their office. It’s putting an objectively generated number to complex movement. ... They also have the opportunity for the patient to wear the sensor home, so they can collect data outside of the clinic in their living or working environment, which then gives a greater insight to the physician, relevant to what the patient is doing outside of the clinic."

Additionally, the devices can be used for biofeedback in the at-home version, telling patients in the moment when they might be moving too much or not enough in the course of a physical therapy regimen.

ViMove is one of three applications for dorsaVi's technology. Another, ViPerform, uses the sensors to measure athletes' performance and assess their recovery from injuries. That product has already been in the US for a while: dorsaVi is working with two NFL teams and is in conversations with NBA and major league baseball teams as well. They also have affiliations with Manchester United, and several other soccer and cricket teams in the UK and India. ViPerform is not FDA cleared as a medical device, but the company says its intended use as a goniometer and biofeedback device doesn't require it.

Their third product, ViSafe, is designed to monitor movement and muscle stress in the workplace to reduce workplace injuries. The company is still in the process of figuring out if that device requires FDA clearance.