VibroSense Meter® II is now registered in Great Britain, which opens up a new market for the company's product. The VibroSense Meter® II facilitates reliable detection and diagnosis of peripheral nerve damage in hands and feet caused by, for example, diabetes, chemotherapy and hand-held vibrating tools.
All medical devices sold in the UK must be registered with the government agency “Medicines and Healthcare products Regulatory Agency” (MHRA). VibroSense Meter® II is now registered and shortly the product will be listed in the MHRA Public database https://pard.m h ra.gov.uk/
In July 2023, a change was introduced in the regulations which means that all CE-marked products according to the MDR can be sold in the UK up to and including 2028, provided that the product is registered with the MHRA.
"The registration of the VibroSense Meter® II means that we can now also sell Diabetic Foot Screening in the UK, which will be a further step forward in our international launch. As we have also received several requests from the UK, it is very gratifying that we can now deliver our product directly to the end customer in a very exciting and large market", says Hans Wallin, CEO of VibroSense Dynamics AB.
Hans Wallin, CEO VibroSense Dynamics AB
Tel: +46 40 88 026
"The new Gold Standard for reliable
detection of nerve damage"
About VibroSense Dynamics AB (publ)
VibroSense Dynamics AB (publ) develops and sells medical technology products and services for diagnostic support for nerve damage in the hands and feet caused by, for example, diabetes, chemotherapy or vibrating hand-held tools. The method involves measuring and quantifying the ability to feel vibrations at several frequencies. The company's customers are diabetes clinics, occupational health care, hospitals, health centers and researchers.
Our vision is that the company's products should be a standard instrument in all neurological examinations to detect early signs of changes in sensation so that patients and their caregivers can implement preventive measures that prevent, reduce or delay the onset of nerve damage in the hands and feet.
About the Medicines and Healthcare products Regulatory Agency (MHRA):
The MHRA regulates medicines, medical devices and blood components for transfusion in the UK. The authority operates within a statutory framework set by HM Government , working within government and the wider health system to guide overall policy within a regulatory framework.
These policies set out the role to ensure improvements in public health and provide powers to deliver against their corporate responsibilities.