Update on the FDA approval process for NeoNavia®
The MedTech company NeoDynamics filed a registration application for its novel pulse biopsy system NeoNavia with the US Food and Drug Administration, FDA, end February. The application was filed in the form of a 510(k), which is a less -burdensome procedure than an application for a new drug. Since then, the authority has initiated a dialogue with the company as is customary. To date, the dialogue has been smooth, and the company has been able to provide the authority with the requested information. The current assessment by analysing other companies in a similar situation, is that the