VibroSense Dynamics AB (publ) announces today that VibroSense Meter® II has received regulatory approval in Thailand, registered as a Class 1 medical device with the Thai Food and Drug Administration (Thai FDA). The approval marks an important milestone in VibroSense expansion in Southeast Asia.
Thailand is one of Southeast Asia's largest healthcare markets, with a rapidly growing medical technology sector and a strong focus on chronic disease management, including diabetes. The country has a well-developed healthcare system with both public and private hospitals, and represents a strategic market for VibroSense continued expansion in the region.
The registration confirms that VibroSense Meter® II meets Thailand's regulatory requirements for safety and performance. The device is used for objective and quantitative measurement of vibration perception in the hands and feet, and for detection of peripheral neuropathy that is not identified by current clinical tools.
"Regulatory approval in Thailand is another important step in our expansion in Southeast Asia. Thailand is a significant healthcare market with a clear clinical need for better diagnostic tools within neurology and diabetes care", says Toni Speidel, CEO of VibroSense Dynamics AB.
For more information, please contact:
Toni Speidel, CEO
VibroSense Dynamics AB (publ)
Phone: +46 40 88 026
Email: info@vibrosense.com
www.vibrosense.com
“Secure and monitor foot and hand health — measure the difference.”
About VibroSense Dynamics AB (publ)
VibroSense Dynamics AB (publ) develops and sells medical devices and services to facilitate diagnosis of nerve damage in the hands and feet. The method is based on measuring and quantifying the ability to perceive vibrations applied to the skin at multiple frequencies. The company's customers include diabetes clinics, occupational health providers, hospitals, primary care centers, and researchers.
Our vision is that the company's products shall become a standard tool in all neurological examinations, to detect early signs of sensory changes so that patients and healthcare providers can take preventive action to avoid, reduce, or delay the onset of nerve damage in the hands and feet.