Mediracer is preparing to enter the US market after the US Food and Drug Administration (FDA) 510(k) review for premarket notification for the Mediracer® NCS device was successfully completed (SE) and clearance to market the device in the US was granted. The FDA clearance will enable Mediracer to expand their business from European and Japanese markets to the US, providing the health care a simple and fast solution for peripheral neuropathy diagnostics and monitoring.
Mediracer manufactures and sells cost-effective and reliable solutions for the field of clinical neurophysiology, for diagnostics and monitoring of peripheral neuropathies, e.g. carpal tunnel syndrome (CTS), diabetic peripheral neuropathy (DPN) and chemotherapy induced peripheral neuropathy (CIPN). Mediracer enables detecting and diagnosing of most common peripheral neuropathies at any clinical setting, thus contributing to fast and correct treatment for patients.
‘We are very excited about this achievement, which will now catalyze our US market entry and negotiations with business partners in USA. The North American market provides a huge opportunity for substantial business growth for Mediracer’, says Georg Meissner, Mediracer CEO
Contact person
Georg Meissner, CEO
georg.meissner@mediracer.com
+358 40 517 0182
Oulu Health
http://ouluhealth.fi/mediracer-receives-us-fda-clearance-for-mediracer-ncs-device/