VibroSense Dynamics AB (VibroSense) clinical validation study for the new application Diabetes Foot Screening, shows that the company's product VibroSense Meter® II meets all essential criteria for approval according to the clinical validation plan. VibroSense thus keeps the schedule the company has previously communicated and is ready to launch the Diabetes Foot Screening application to both primary and specialist care.
During the fall of 2020, VibroSense Dynamics AB has conducted a clinical validation study with the new application Diabetes Foot Screening, designed for the company's product VibroSense Meter® II. The results of the study data obtained so far show that the application is approved according to the essential criteria set out in the clinical validation plan.
The validation study includes patients with both type 1 and 2 diabetes, which conclude that the product VibroSense Meter® II can be sold to both primary and specialist care. This is an important milestone and means that the company can target both of these segments that make up the majority of the market in the diabetes indication area.
- The fact that VibroSense is now ready to launch Diabetes Foot Screening is a major step forward and further confirmation that we are able to keep the plan we have previously communicated to the market. The results of the study confirm our technology and we are of course satisfied. We will now begin the next phase which is to present the product to healthcare providers in the indication area Diabetes, says Hans Wallin, CEO of VibroSense Dynamics AB.
Hans Wallin, CEO VibroSense Dynamics AB
Tel: +46 40 88 026
About VibroSense Dynamics AB (publ)
VibroSense Dynamics AB (public) develops, manufactures and sells 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. Our vision is that the VibroSense Meter shall be the golden standard instrument for neurological examinations to assess sensory neuropathy and help to improve life conditions for patients having a risk of getting nerve injuries.