Probefix enters European market with CE approval


Door Bart Brouwers
Leestijd ± 2 minuten
  • 10 August 2017

Now that the official (and necessary) CE approval is received, the Eindhoven startup Usono can enter the European market. Thanks to a distribution contract with the Danish Mermaid Medical, that is already assured for the Netherlands, Great Britain, Denmark, Sweden, Norway, Finland and Iceland for the next four years. Germany, Belgium, France, and Italy are expected to follow soon.

Usono makes a device with which it becomes easier to make an ultrasound: It fixes the position of the device so that the physician has both hands free for operation. Co-founders Benjamin Tchang (CEO), Victor Donker (COO) and Jori Verbeek (CTO) have now, a year after their start in HightTechXL, assembled a team of designers and business developers, which accelerated the production. Usono is located on the High Tech Campus and on the Health Innovation Campus of the Maxima Medical Center in Veldhoven.

The CE marking is a prerequisite for the sale of medical products in Europe.

“We were already carefully working on sales through pre-orders and official quotations in the Netherlands and Belgium”, says Victor Donker. “But with Mermaid Medical, a specialist in the field of sales of accessories for ultrasound, it all accelerates. As a result, we must be able to sell hundreds of ProbeFixes and hundreds of thousands of disposable straps in the coming years.”

Usono has been working internationally from the start: demo models were used in Pisa with the inventor of the stress echo procedure and in Liverpool at a hospital specialized in heart disease.

 

The first production started thanks to the collaboration with a number of regional partners. The material tires come from Liebaert in Deinze and are processed by Conpak in Beek en Donk. SKM Rapid Modelling in Helmond is responsible for the production of ProbeFix itself, while Demcon from Son played an important role in obtaining the CE marking. There is also still a cooperation with the faculty Biomedical Technology of the TU/e.

“From September we also want to expand our team”, says Donker. “That way we can get started with the development of our next product, where continuous hands-free monitoring in ultrasound will again be key. The ProbeFix is only the first example of a smart ultrasound solution, the next products will be even smarter.”