Tag: medical device

AI Code of Conduct’s six core principles key to ensuring the safe and effective use of AI technologies 

Join our two-day seminar designed for pharmaceutical, biopharmaceutical, biologics, and medical device professionals to master FDA inspections. Gain hands-on strategies to efficiently prepare, conduct, and respond. Includes slides, certificates, Q&A, and inspection handouts. Optimize outcomes.

GlucoModicum Reports Positive Clinical Results with its Needle-Free CGM and Advances Toward Market Launch

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.

Combined Company Expected to be Listed on NASDAQ Global Market

VANCOUVER, British Columbia, June 30, 2025 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (TSXV: RKV) (the “Company”) announces that it will apply to the TSX Venture Exchange (the “Exchange”) to amend the terms of certain outstanding warrants and convertible debentures of the Company, as further described herein.