Tag: medical device

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.

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VANCOUVER, British Columbia, June 25, 2025 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO0) (“Rakovina” or the “Company”), a biopharmaceutical company advancing next-generation cancer therapies through artificial intelligence (AI)-powered drug discovery is pleased to announce the results of voting at its 2025 annual general meeting of shareholders held on June 25, 2025, in Vancouver, British Columbia (the “Meeting”).

Innovative needle-free technology empowers users to monitor glucose signals, oxygen saturation, and heart rate from home—without the discomfort or complexity of traditional tools.