Tag: clinics

THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014)

EINDHOVEN, the Netherlands, July 01, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilities, today announced the submission of two major regulatory applications for its ARC-EX System. The Company has submitted a 510(k) application to the US Food and Drug Administration (FDA) seeking clearance to expand its indication for home use. In parallel, ONWARD has filed an application with the notified body for CE Mark certification in accordance with the European Union Medical Device Regulation (MDR) to enable commercialization of the ARC-EX System in the EU. Completed in June, these submissions represent significant milestones as the Company advances its mission to bring breakthrough therapies to people with SCI around the world.

BRIDGEPORT, CT, June 27, 2025 (GLOBE NEWSWIRE) -- The two leading academic institutions have joined forces with TulsiHub Institute, the premier provider of advanced CE certified regenerative medicine certification programs, to transform medical education standards across regenerative medicine and cellular therapy disciplines. This innovative alliance positions both universities as pioneers in cutting-edge healthcare training while establishing new industry standards for professional medical certifications and continuing medical education in the rapidly expanding regenerative healthcare sector.