Tag: medical devices

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

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SAN DIEGO, June 27, 2025 (GLOBE NEWSWIRE) -- The law firm of Robbins Geller Rudman & Dowd LLP announces that the Organon class action lawsuit – captioned Hauser v. Organon & Co., No. 25-cv-05322 (D.N.J.) – seeks to represent purchasers or acquirers of Organon & Co. (NYSE: OGN) securities and charges Organon as well as certain of Organon’s top executives with violations of the Securities Exchange Act of 1934.

NOVI, Mich., June 27, 2025 (GLOBE NEWSWIRE) -- Gentherm (NASDAQ: THRM) a global market leader of innovative thermal management and pneumatic comfort technologies, today announced the expansion of its long-standing partnership with DUOMED into France. Building on years of successful collaboration in the Benelux region, this extension marks a strategic milestone as both companies work to deliver advanced patient temperature management technologies to more clinicians and patients across Europe.