VibroSense Dynamics (VibroSense) has received a CE registration certificate of the company's new product VibroSense Meter II, by the Swedish Medicines Agency. The product is thus CE-marked and meets all requirements for sale, as a Class I medical device, within the EU. The instrument can also be sold in all other European countries harmonized with the EU regulations for CE marking of medical devices.
After extensive work, VibroSense has met all requirements for CE marking of VibroSense Meter II. This includes everything from ensuring that VibroSense Meter II is safe for patients and operators, to that the instrument works according to the declared intended purpose.
- "We are now ready to sell VibroSense Meter II to customers working with healthcare within diabetes and CIPN, Chemotherapy-Induced Peripheral Neuropathy. Potential customers and research projects can thus be given the opportunity to evaluate VibroSense Meter II clinically to decide on the purchase or licensing of the instrument, says Toni Speidel, CEO VibroSense Dynamics AB.
This information is information that VibroSense Dynamics AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on July 26th 2018.
About VibroSense Dynamics AB (publ)
VibroSense Dynamics AB (public) develops and markets efficient systems to support early detection and diagnosis of sensory neuropathy, i.e. disease of large nerve fibres and nerve trunks in e.g. legs and arms. The Company, founded in 2005, has been listed on Spotlight stock market since May 2015