Neuromersiv has announced the inclusion on the ARTG of their novel brain rehabilitation device. This clears the way for commercialisation of this new treatment in Australia and marks the culmination of Neuromersiv’s work with Vestech Medical in developing their QMS as required for their Class I software device.
Neuromersiv, a Medtech start-up, has a vision to make brain rehabilitation therapy more engaging using Virtual Reality. This is achieved in their Ulyssess software, which is installed on a commercial VR headset, as it guides the user in daily activities, such as making a cup of tea in the kitchen.
Vestech Medical was engaged to create a QMS to support the software development so it met the TGA’s requirements. Vestech Medical also assisted Neuromersiv in the creation of technical documentation, leading to and supporting their successful TGA submission including responding to the TGA’s question through the process.
- On 17 January 2023