|By Business Wire||
|July 14, 2014 09:28 PM EDT||
Wearable medical device company dorsaVi Limited (ASX:DVL) has today announced it will commence launch of ViMove in the United States following 510K clearance by the US Food and Drug Administration (FDA) for measuring, recording, and reporting on movement and muscle activity of the lower back / lumbar spine.
“This is a terrific achievement for dorsaVi and opens up substantial opportunities for us in the United States. dorsaVi has successfully implemented a stepped approach in the US, one of the biggest market opportunities for the company with approximately 280,000 physical therapists and 660,000 physicians,” said dorsaVi CEO, Andrew Ronchi.
ViMove consists of wearable sensors that are placed on the body to measure movement and muscle activity. Patients can be assessed through a series of movements or exercises performed in-clinic, or outside the clinic, at home or at work, where ViMove can monitor their everyday activities, and provide immediate biofeedback to the patient and a concise report for the healthcare practitioner.
510K clearance is required for certain types of medical devices before a manufacturer can introduce a device into commercial distribution for the first time in the US market.
dorsaVi’s US President John Kowalczyk added: “Over the next couple of weeks, we will be adding to our established sales team to meet the anticipated growing demand that has been generated from international awareness and success.”
“Healthcare reform in the US 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 We are extremely excited about ViMove’s FDA clearance.”
FDA Intended Use/Indications for Use:
ViMove is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.
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