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Tag: neurotechnology

Wave Neuroscience Announces FDA Clearance of MeRT® for PTSD

FIRST-EVER FDA-CLEARED PERSONALIZED CLINICAL TREATMENT SYSTEM FOR POST-TRAUMATIC STRESS DISORDER (PTSD) ESTABLISHES A NEW CATEGORY IN PRECISION MENTAL HEALTHCARENEWPORT BEACH, Calif., June 11, 2026...

ONWARD Medical Announces the Appointment of Lucas Buchanan to its Board of Directors

EINDHOVEN, The Netherlands, Aug. 06, 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 announces the appointment of Lucas Buchanan as a non-executive member of its Board of Directors.

ONWARD Medical Adds Entrepreneur and Neurotechnology Thought Leader Tim Denison, PhD to its Board of Directors

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

ONWARD Medical Files 510(k) with US FDA for ARC-EX System Home Use and Submits CE Mark Application

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.

ONWARD Medical Announces Results of its Annual General Meeting of Shareholders

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

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