Australian medical device company DorsaVi saw shares jump approximately 8.6% today after the company announced it had won FDA 510(k) clearance for its ViMove2 muscle activity sensor.
The ViMove2 sensor is designed to measure, record and analyze movement and muscle activity in the lower back, and includes Bluetooth communication and a mobile application for both patient and clinicians to access real-time info from the sensor, the company said.
The ViMove2 sensor also features an accelerometer and gyroscope for measuring the range of movement in the sagittal and coronal anatomical planes.
“The FDA’s 510(k) clearance for ViMove2 is an important milestone for the company as the product has a mass market clinical opportunity. ViMove2 is highly intuitive, simple and a faster to use device that is patient-friendly. The addition of a patient app allows patient and therapists to monitor progress and improve adherence to treatment regimes; ultimately leading to better patient outcomes through quality movement data,” CEO Dr. Andrew Ronchi said in a prepared statement.
DorsaVi said it is planning for a US launch of the device during the 4th quarter of next year. The device was launched in Australia in May, and has a slated roll-out in the UK for the 2nd quarter of 2018, the company said.
Shares rose 8.6% yesterday to close at 38¢.