Theraclion: Sonovein® Receives MDR Certification, Strengthening Its Commercial Potential

About this update from Theraclion Sa

[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":1000,"height":375,"url":"https://media.zenfs.com/en/business-wire.com/7e21f0b16048c8252209a5e7acdff5b6"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/3d.Q9rVjcGaRn173yVx62Q--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTM2MDtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/7e21f0b16048c8252209a5e7acdff5b6","width":960,"height":360},"lightbox":{"url":"https://s.yimg.com/ny/api/res/1.2/RDGWDhavaPVhJveNYxEd0g--/YXBwaWQ9aGlnaGxhbmRlcjt3PTIwMDA7aD03NTA7Y2Y9d2VicA--/https://media.zenfs.com/en/business-wire.com/7e21f0b16048c8252209a5e7acdff5b6","width":1000,"height":375}},"lazy":false},{"type":"text","content":"MALAKOFF, France, September 24, 2025--(BUSINESS WIRE)--Regulatory News:","length":71,"tagName":"p"},{"type":"text","content":"THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative company developing Sonovein®, a robotic platform for non-invasive High-Intensity Focused Ultrasound (HIFU) varicose vein treatment, announces today that it has received MDR (Medical Device Regulation, EU 2017/745) certification for Sonovein®.","length":303,"tagName":"p"},{"type":"text","content":"The MDR is the European Union’s regulatory framework for medical devices. It is considered one of the strictest in the world, raising the bar for safety, quality and performance in the MedTech industry. The independent assessment confirmed that both the Sonovein® device and Theraclion’s quality management system fully comply with the MDR requirements, opening the way for the long-term commercialization of the latest generation of Sonovein®.","length":444,"tagName":"p"},{"type":"text","content":""Achieving MDR certification is not just about meeting regulatory requirements," said Martin Deterre, CEO of Theraclion. "It reflects years of continuous improvement, our team’s relentless work, and our commitment to providing physicians and patients with innovative treatment solutions that truly make a difference. Coupled with our pivotal trial results, this certification will give a decisive boost to our commercial efforts across Europe and other MDR markets."","length":486,"tagName":"p"},{"type":"text","content":"Theraclion has held CE Mark certification for Sonovein® under the Medical Device Directive since 20...

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