The MedTech company NeoDynamics has appointed Decomplix as representative in Switzerland, to facilitate and ensure that its novel biopsy system NeoNavia meets all legal requirements in the local market.
Since late May 2022, Switzerland requires all foreign manufacturers that places medical devices on the Swiss market to appoint a Swiss Authorized Representative. The role of the representative is to be a point of contact with authorities, keep technical documentation at hand and support with vigilance inquires.
“Switzerland is set to be an important market for NeoDynamics, since it is a market where physicians strive to deliver care of exceptional quality. For us that translates into strong interest in our innovative pulse biopsy system NeoNavia,” says Renate Reiss, General Manager DACH. “Europe is a critical region for the company as we have gained tremendous experience during the product’s clinical use.”
“We are very excited to represent NeoDynamics as Swiss Authorised Representative, facilitating their market access in Switzerland,” said Beni Hirt, Decomplix CEO.
For further information, please contact:
Anna Eriksrud, CEO NeoDynamics AB, phone +46 (0) 708 444 966 or e-mail firstname.lastname@example.org
Renate Reiss, General Manager DACH, phone +49 (0) 151 4188 6209 or e-mail email@example.com
NeoDynamics AB (publ) is a Swedish Medical Technology Company dedicated to advancing diagnosis and care of breast cancer. The company’s first product NeoNavia®, a new innovative pulse biopsy system for ultrasound guided tissue sampling, is currently being introduced to the market. The biopsy system is built on a patented pulse technology, based on research at the Karolinska Institutet in Sweden. NeoNavia is evaluated for breast cancer diagnosis at leading clinics in UK, Germany, and Sweden. The pulse biopsy system has been used for tissue sampling in breast and axilla in over 500 patients. NeoDynamic´s share is listed on Nasdaq First North Growth Market Stockholm (ticker: NEOD). The company’s Certified Adviser is Redeye AB.
NeoNavia is a modern biopsy system with a completely new patented pulse technology intended for ultrasound-guided tissue sampling. It consists of a base unit, a handheld driver and three different types of biopsy needles. Each needle type is driven by the pulse technology providing a more controlled needle insertion and precise placement of the needle in the tumour whilst enabling high-quality tissue samples from both breasts and lymph nodes. The pulse biopsy system NeoNavia is designed to offer clinicians and patients accurate lesion targeting and high tissue yield for correct diagnosis and individualized treatment. NeoNavia received US approval from the US Food and Drug Administration, FDA, in September 2022.