The VibroSense Meter® II system (VSM II) is registered to comply with the new EU Medical Device Regulation (MDR) as a class 1 Medical device. A registration is made at the Swedish Medicines Agency where VibroSense Dynamics has received the EUDAMED registration number (SRN) SE-MF-000003787. Thus, the VibroSense Meter® II system has now a CE-mark which complies with the new MDR which became mandatory within the EU since May 26, 2021.
Press Releases and News
| Press releases
| Regulatory press releases
The result from a clinical pilot study, in collaboration with the clinic of Oncology at the university hospitals in Lund and Malmö as well as the hospital in Kristianstad, shows that VibroSense Meter® and its technology can be used to predict the risk of getting permanent nerve damage caused by treatment of cancer with chemotherapy. The discovery is an important step to pave the way for a new biomarker that can support physicians within cancer treatment with chemotherapy.
| Regulatory press releases
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.
| Regulatory press releases
At the scientific congress, Humanchwingungen in Würzburg Germany on October 1 2020, the results of a pilot study were presented in which the company's product VibroSense Meter® II was used. The aim of the study was to investigate short-term effects of exposure to hand-arm vibrations. The result showed a strong impact wherein a significant decrease of the sensitivity of fingers was detected with the VibroSense Meter® II. The data will become the basis for new recommendations for health controls of vibration-exposed personnel in Germany.
| Press releases
VibroSense Dynamics AB (VibroSense) has started a clinical validation of the new Diabetes Foot Screening application in the product VibroSense Meter® II. Clinical validation is the final step before the product is ready for launch within the diabetes foot care segment.
| News
VibroSense Dynamics AB (VibroSense) has received an "Intention to grant" from the Swedish Patent Office and a positive Written Opinion from an international PCT application. The patent covers an important part of VibroSense’s measurement technology to measure skin temperature continuously during an examination with VibroSense Meter® II.
| Press releases
VibroSense Dynamics AB (VibroSense) adds a new application to its product VibroSense Meter® II, which provides support for Diabetes Foot Screening. The new application is a result of 5 years of clinical studies involving adult patients with type 1 diabetes and is expected to be available for commercial launch in the fall 2020.
| Press releases
The Institute for Occupational and Environmental Medicine at Lübeck University Hospital (LIOH, Lübeck Institute of Occupational Health) has decided to purchase the VibroSense Meter II after completing a pilot study. The conducted study aimed at testing temporary impairments of sensitivity at fingers caused by short-term exposure to vibration. A larger study is now planned with the VibroSense Meter II to investigate whether the instrument can be used as a supervising tool to prevent vibration injuries caused by vibrating tools.
| Press releases
VibroSense Dynamics appoints Jan Kleijn Hesselink as Manager for the Benelux. This is a first step towards a planned geographic market expansion outside of Scandinavia for VibroSense Dynamics.
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Doctor Eero Lindholm at Skåne University Hospital presented unique results from clinical study of Diabetic Peripheral Neuropathy (DPN) of feet in patients with type 1 diabetes. The results were presented at the world's second largest diabetes congress - EASD in Barcelona on September 17, 2019. The conclusion was that VibroSense technology and instruments can be used instead of Nerve Conduction Studies (NCS), for early diagnosis of nerve damage in feet caused by type 1 diabetes.
| Press releases
Avonova has decided to set up a nationwide organization in Sweden for health control of workers exposed for hand-arm vibrations. To perform these health controls, Avonova has signed a license agreement for 24 VibroSense Meter II, with option of additional instruments. The license agreement initially covers 36 months with the possibility of renewal. The agreement will have a positive impact on VibroSense Dynamics' results for current fiscal year.
| Press releases
A published study authored by researchers at the clinic of Occupational and Environmental Medicine at Sahlgrenska University Hospital provides strong support for VibroSense Dynamics' new method for screening of workers, exposed for hand- arm vibrations. The screening method, developed by VibroSense together with two companies in Occupational Health Care services in Sweden, means that an examination can be made in less than 10 minutes. The method will be important for VibroSense expansion in Germany, among others.
| Press releases
The Lübeck Institute of Occupational Health (LIOH) at Lübeck University Hospital plans to make a large study using VibroSense Meter II. The purpose of the study is to investigate how to prevent vibration damage caused by vibrating tools. The study starts with a pilot study wherein the VibroSense Meter system is rented during four months with an option to buy the instrument.
| Press releases
Den Kliniska Onkologiska Avdelningen vid Sjællands Universitetshospital i Roskilde köper en VibroSense Meter II från VibroSense Dynamics i syfte att genomföra tre kliniska studier. I forskningsavtalet ingår en option på att köpa ytterligare två instrument. De kliniska studierna startar den 1 september 2019 och genomförs på patienter med bröst-, äggstocks- och kolorektalcancer. Studierna syftar till att undersöka hur nerver i fötter och händer påverkas av cellgiftsbehandling.
| Press releases
The senior specialist at Skåne University Hospital, Dr. Eero Lindholm, will present unique results from a clinical study of nerve damage in feet in patients with type 1 diabetes. The study shows that there is a strong correlation between Nerve Conduction Studies (NCS) and Multi Frequency Vibrometry with VibroSense Meter. The results shall be presented on EASD (European Association for the Study of Diabetes) in Barcelona in September 2019, where VibroSense also will participate as an exhibitor.
| Press releases
Avonova invest heavily to prevent vibration damage due to the swedish work environment Authority's increased focus on vibration damage. Avonova and VibroSense Dynamics have signed a letter of intent with the aim of set up a nationwide organization for health care examinations of workers exposed to vibration. The initiative is a direct result of increased demand from the company's customers and means that Avonova intends to buy 24 VibroSense Meter II.
| Regulatory press releases
Den 10 april 2019 höll VibroSense Dynamics AB (publ) (”Bolaget”) en extra bolagsstämma på Medeon Science Park i Malmö. Godkännande av styrelsens beslut om nyemission av aktier och teckningsoptioner (units)
med företrädesrätt för befintliga aktieägare.
| Press releases
A study published in the scientific journal PLOS ONE shows a strong correlation between impaired sensitivity on low frequencies and foot ulcers. Behind the study are five prominent researchers from Lund University and Skåne University Hospital in Malmö.
| Press releases
On 28 and 29 November 2018, the European Innovation Council (EIC) and Medtronic, a leader in the world of medical technology, gathered 20 companies to discuss the transformation of healthcare and promote business partnerships. VibroSense shared its solutions for early detection and diagnosis of nerve injuries in hand and foot (peripheral sensory neuropathy) caused by diabetes or by chemotherapy treatment of cancer.
| News
Preliminary results from studies conducted in collaboration with VibroSense Dynamics AB (VibroSense) research network indicate that the company's instruments and technology have a high potential for detecting early neurological changes in diabetes and the treatment of cancer with chemotherapy. The company's product thus takes an important step to become part of the therapy in these areas.