dorsaVi has received 510(k) clearance from the US Food and Drug Administration (FDA) to expand the use of ViMove in the USA.
This expanded functionality and labelling permits the use of ViMove to display lower back and pelvic range of motion from healthy patients for the first time in the USA. Clinicians and their patients will now be able to compare how their movements are tracking against a normal population based on their age group, and help guide therapy decisions and rehabilitation accordingly.
The expanded labelling also permits dorsaVi to record, assess and report on additional static postures including lumbar lordosis and on various sitting postures. The inclusion of the pelvic movement data allows clinicians to independently isolate lumbar spine and pelvic movements.
As part of the submission to achieve the new labelling, the ViMove data was validated against sophisticated optical tracking sensors (Vicon) used in biomechanical laboratories, and with a marker set clinically validated against magnetic resonance imaging for a range of lumbopelvic movements. All ViMove data for standing and sitting postures was accurate to within 5 degrees.
ViMove was previously 510(k) cleared in July 2014.