Wearable biosensor for assessing back injuries wins FDA clearance

dorsaVi's wearable ViMove--Courtesy of dorsaVi

Australia's dorsaVi just received 510(k) clearance from the FDA for its wearable biosensor for assessing movement in the spine and lower back.

"Healthcare reform in the U.S. is mandating quantitatively generated data. ViMove gives healthcare providers the ability to truly assess movement of the lower back and will aid in the development of treatment plans for many patients," the company's U.S. president and former Medtronic ($MDT) executive John Kowalczyk said in a statement.

The collection of four sensors can be worn in the clinic, at work or at home. Feedback gathered from the four sensors during exercises informs patients and forms the basis of a report sent to doctors. The sensors contain an accelerometer, magnetometer and gyroscope to track movement, as well as a diagnostic electromyography sensor, according to MobiHealthNews.

"The benefit of this is the fact that physicians can do this assessment in their clinic," Kowalczyk 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." He continued, "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."

The biosensor could help lower healthcare costs by preventing unnecessary procedures. Medicare estimates that $200 million is wasted on unnecessary and invasive spinal fusion surgeries, says a report by market research firm GlobalData.

DorsaVi's ViPerform is already used by NFL, NBA and MLB professional sports teams (as well as other leagues internationally) to assist athletic performance; the company says it does not need FDA permission for this non-medical use. It is now assessing the possibility of bringing its ViSafe device for assessing muscle movement and stress to the workplace to the U.S., according to MobiHealthNews.

The clearance marks the advent of movement tracking devices. And not just eye tracking. For example, Washington, DC's modus health is marketing an FDA-cleared step monitor device for patients undergoing rehabilitation. Now, dorsaVi is joining the still-exclusive club of companies providing regulated movement trackers for healthcare purposes.

- read the release
- read the MobiHealthNews article

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