On September 8, 2022 The MedTech company NeoDynamics reported that received approval for its innovative pulse biopsy system NeoNavia from the US Food and Drug Administration, FDA (Press release, NeoDynamics, SEP 8, 2022, View Source [SID1234619295]).

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The US breast biopsy market is estimated to reach $830 million by 2025.

"The FDA approval for NeoNavia is a major milestone for NeoDynamics and a stamp of quality for both the product and NeoDynamics as a whole," said Anna Eriksrud, CEO of NeoDynamics. "The US represents the potentially largest market for the product, where we now also can build on the experience gained with the system in Europe. Preparation for the launch is ongoing and we expect to begin introducing the system to clinicians and potential partners within the next few months."

NeoDynamics intends to work with US clinics to further document the product in clinical practice to support its marketing and sales strategy. A similar strategy is successfully being executed on in Europe, demonstrating the benefits of the product while forging relationships with important clinics to facilitate a broad acceptance and uptake of the system.

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. The product has CE approval in Europe, where it is in clinical use.