SpineGuard, has filed a 510(k) regulatory dossier with the US Food and Drug Administration (FDA), seeking authorisation to commercialise its Dynamic Surgical Guidance (DSG) sensing technology, DSG Connect platform, in the USA. The sensing technology is used to secure and streamline the placement of bone implants.
DSG Connect is a tablet based software interface that adds visual interpretation to the auditory feedback for optimal exploitation of the signal during pedicle screw placement. It also allows for data recording of bone impedance values as evidence of optimal screw placement within the pedicle and for bone quality studies. The platform received CE mark approval in April.
Already being utilised experimentally in a new strategic high value platform to guide surgical robots, SpineGuard will now apply the platform to its entire range of products, the company said in a press release. The commercialisation in the USA will commence as soon as the file is validated, which can take three to nine months.
Stéphane Bette, co-founder and Deputy CEO of SpineGuard, said: “SpineGuard generates a large portion of its revenue in the USA, the first market worldwide in our sector that strongly rewards innovation. Therefore, it is our priority to quickly clear there the innovations that we launch. We are very proud, during the COVID-19 period, to have assembled this regulatory file which is substantial because for the first time in the history of the company it entails radio frequency transmission, as well as a software application on a visual terminal. On the heels of the recent CE mark, as spine surgeries progressively resume in Europe, we will soon perform the first surgery in France with DSG Connect, and we look forward to doing the same in the USA.”