DorsaVi Earns Expanded Clearance for Spine Movement Tracking System

Australian Medical device company DorsaVi Ltd. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) expanding the use of the company’s ViMove technology in the United States.

ViMove is wearable sensors for measuring, recording, and reporting on movement and muscle activity of the lower back/lumbar spine.

According to company officials, the expanded functionality and labeling is “highly significant” because it allows for the use of ViMove to display lower back and pelvic range of motion from healthy patients (normative data). Clinicians and their patients now will 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 labeling 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 labeling, the ViMove data was validated against sophisticated optical tracking sensors used in biomechanical laboratories, and with a marker set clinically validated against magnetic resonance imaging for a range of lumbar/pelvic movements. All ViMove data for standing and sitting postures was accurate to within 5 degrees, company officials claim.

“This is an important breakthrough for clinicians and patients,” said Andrew Ronchi, CEO of DorsaVi.

ViMove previously was 510(k) cleared in July 2014.

“The 510(k) clearance by the FDA, which enables the expanded use of ViMove in the United States, is a major milestone for dorsaVi and will allow us to increase our marketing efforts to physical therapists and health care professionals globally,” said John Kowalczyk, president of DorsaVi USA.

DorsaVi develops motion analysis device technologies for use in clinical practice, sports, and occupational health and safety. The company officials claims that the firm’s wearable sensor technology “enables, for the first time, many aspects of detailed human movement and position to be accurately captured, quantified and analyzed outside a biomechanics lab, in both real-time and real situations for up to 24 hours.”

DorsaVi is headquartered in Melbourne, Australia, with U.S. offices in Plymouth, Mass.