As expected Australia-based medical device company dorsaVi has received a new FDA 510(k) that expands the use case for the suite of wearable sensors, called ViMove, to allow providers to use them for tracking additional static postures like a natural standing posture and various sitting postures. The new clearance also enables providers to use the devices to track healthy patients and establish a benchmark of normal movements for a given age group, which can help guide therapy and the development of a rehab program.
John Kowalczyk, President of dorsaVi USA said in a statement that the clearance allows it to increase its marketing to physical therapists in particular.
The company secured its first FDA clearance for ViMove last summer.
Earlier this spring dorsaVi launched its first product for the US market, a workplace safety device offering, called ViSafe. With the ViSafe system, a worker wears the tracker periodically during work tasks, and the software analyzes data about the strain the work is putting on different muscles and joints. From there, ViSafe makes recommendations about what sorts of movement the worker should reduce or avoid.
“From those recommendations, we would work with the client or the insurer to say how would we ergonomically change the areas of risky movement to reduce the cumulative effect over time, which we believe will then translate to a reduction in injury, which then translates to a reduction in workers’ comp costs and the associated challenges with work-related injuries,” Kowalczyk told MobiHealthNews in an interview in April.
While ViMove is only available in Australia, New Zealand, and the UK, currently, this second clearance coupled with dorsaVi's launch of ViSafe in the US this spring, makes a US launch of ViMove increasingly likely.
DorsaVi is also targeting professional sports with its various offerings. Already ViPerform is used by sports teams in Australia and various Olympic teams and athletes internationally, according to the company. DorsaVi has told MobiHealthNews in the past that its ViPerform technology is used by NBA, NFL, and soccer teams in the US, too.
