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NeoDynamics received FDA clearance

NeoNavia base unit

The company has received approval for its pulse biopsy system NeoNavia from the US Food and Drug Administration, FDA.

“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,” says Anna Eriksrud, CEO of NeoDynamics, in NeoDynamics’ press release. “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 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., describes the company in its press release.

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

Photo of the NeoNavia base unit