NeoDynamics has filed for registration of NeoNavia® in the US

The MedTech company NeoDynamics has filed a registration application for its innovative pulse biopsy system NeoNavia® with the US Food and Drug Administration, FDA. The product already has CE approval in Europe and is in clinical use.

“By filing for registration of NeoNavia in the US, NeoDynamics reaches an important milestone. The US is a huge potential market for NeoNavia and a US registration is also an important seal of quality for future collaborations”, says CEO Anna Eriksrud. “We expect that it will take a number of months to get the registration application approved.”

The application, which is submitted after dialogue with the FDA, is filed in the form of a 510(k), which is a less complicated procedure than an application for a new drug. Once the product has received marketing approval, NeoDynamics intends to continue to work with clinics to document the product in clinical practice to support its marketing and sales strategy. Similar has been done in Europe successfully to demonstrate the benefits of the product, which have contributed to creating a broader interest around the NeoNavia system. In turn, this will develop long term relationships with physicians and facilitate sales.

NeoNavia is an innovative biopsy system that uses a patented pulse technology for controlled and accurate needle insertion, which is based on research at Karolinska Institutet. NeoDynamics’ goal is for the pulse technology to become the new standard for ultrasound-guided breast biopsies. PR Newswire