Medical device company dorsaVi has received 510(k) clearance by the US Food and Drug Administration expanding the use of ViMove in the US.
The expanded functionality and labelling is highly significant because for the first time in the USA it permits the use of ViMove to display lower back and pelvic range of motion from healthy patients (normative data).
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.
Importantly, this new expanded labelling also permits dorsaVi to record, assess and report on additional static postures including lumbar lordosis (natural standing posture) 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 (MRI) for a range of lumbopelvic movements. All ViMove data for standing and sitting postures was accurate to within 5 degrees.
"This is an important breakthrough for clinicians and patients," said Andrew Ronchi, CEO of dorsaVi.
ViMove was previously 510(k) cleared in July 2014 and with this latest clearance, improves the clinical capabilities of ViMove.
John Kowalczyk, President of dorsaVi USA added: "510(k) clearance by the FDA, which enables the expanded use of ViMove in the US , is a major milestone for dorsaVi and will allow us to increase our marketing efforts to physical therapists and health care professionals globally."