Sam Brusco09.08.22
NeoDynamics has received U.S. Food and Drug Administration (FDA) approval for its NeoNavia pulse biopsy system.
The innovative biopsy system uses patented pulse technology for controlled, accurate needle insertion. The company’s goal is to make pulse technology the new standard for ultrasound-guided breast biopsies. The product also has CE mark approval in Europe.
NeoDynamics will work with U.S. clinics to further document NeoNavia to support marketing and sales strategy. A similar strategy is underway in Europe.
"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," Anna Eriksrud, CEO of NeoDynamics told the press. "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."
The innovative biopsy system uses patented pulse technology for controlled, accurate needle insertion. The company’s goal is to make pulse technology the new standard for ultrasound-guided breast biopsies. The product also has CE mark approval in Europe.
NeoDynamics will work with U.S. clinics to further document NeoNavia to support marketing and sales strategy. A similar strategy is underway in Europe.
"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," Anna Eriksrud, CEO of NeoDynamics told the press. "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."