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NeoDynamics receives ethical approval for German device registry

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Claus Thestrup

Claus Thestrup

CEO, HCA Capital Sweden

The MedTech company NeoDynamics has received a favorable decision by the ethical committee of the Medical Association of Hesse, to establish a device registry in Germany for its novel biopsy device NeoNavia. The registry will be used to gather and evaluate real world data from the use of NeoNavia.

“The registry is an efficient tool to obtain real-world-data from the use of our device in routine clinical practice. We can use it to confirm the benefits of the device, monitor safety, and even document off-label use. By proactively collecting and evaluating quality controlled clinical data we strive to meet and exceed the highest regulatory requirements on post-market clinical follow-up as set forth by the new Medical Device Regulation in Europe,” says Kai-Uwe Schässburger, Director of Clinical Development and Medical Affairs at NeoDynamics.

With the favorable decision from the ethical committee, NeoDynamics can proceed with the project and recruit clinics to participate in the process by gathering data.

Neodynamics is a Swedish medical technology company that works to improve the treatment and diagnosis of cancer. The company’s first product is NeoNavia, which is a modern biopsy system with a completely new and patented pulse technology that is intended to be used for ultrasound-guided tissue sampling. The NeoNavia pulse biopsy system is designed to offer physicians and patients accurate and reliable tissue sampling that enables accurate diagnosis and individualized treatment. NeoNavia is being evaluated for the diagnosis of breast cancer at leading clinics in the UK, Germany and Sweden.

Disclaimer: HC Andersen Capital receives payment from NeoDynamics for a DigitalIR/Corporate Visibility agreement.