Tag Archive for: medical device

Neuraxpharm and Dizlin Pharmaceuticals Announce Global Strategic Co-Development Agreement Bringing Next-Generation Drug-Device Therapy to Patients with Advanced Parkinson’s Disease

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Infudopa SubC® is a user-friendly and minimally invasive alternative enabling flexible dosing and thereby empowering patients with greater independence Düsseldorf, Germany and Gothenburg, Sweden – 8 July 2025 – Neuraxpharm Group (“Neuraxpharm”), a leading European specialty pharmaceutical company dedicated to central nervous system (CNS) disorders, and Dizlin Pharmaceuticals AB (“Dizlin”), a Swedish R&D company focused […]

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Sequana Medical Announces US FDA Approval of alfapump® for the Treatment of Recurrent or Refractory Ascites due to Liver Cirrhosis

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alfapump® is the first US approved active implantable medical device (Class III) for the treatment of recurrent or refractory ascites due to liver cirrhosis PMA Approval and FDA Breakthrough Device Designation US market opportunity estimated at over $2 billion in 2025, growing at 9%[1] due to MASH/NASH[2] and alcoholic liver disease US commercial launch planned for H2 2025 […]

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Xeltis expands leadership team with appointment of Luc Verhees as Vice President of Clinical Business Development

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Brings over 30 years of experience in cardiovascular clinical research, business development, training, education, and medical affairs Strengthens Xeltis’ leadership team following IDE approval for initiation of US pivotal study for aXessTM, its restorative vascular access conduit EINDHOVEN, The Netherlands, 5 November 2024 – Xeltis, a leading developer of transformative implants that enable the natural […]

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Amber Implants Completes Enrolment of First-In-Human Clinical Trial of its VCFix® Spinal System

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The Hague, Netherlands, 11 June 2024: Amber Implants (‘Amber’ or ‘the Company’), an innovative medical technology company developing next-generation implants for spinal injuries, today announces that it has completed enrolment of its first-in-human clinical trial with its innovative VCFix® Spinal System. The VCFix® Spinal System is the first device that does not rely on bone […]

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Zephyrus Innovations appoints David Whitaker as Chief Technology Officer

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Vancouver, Canada – 30 May 2023: Zephyrus Innovations (Zephyrus), a privately-owned medical device company designing and manufacturing safety syringes and Closed System Transfer Devices (CSTDs), today announces the appointment of David Whitaker as Chief Technology Officer. David brings with him more than 20 years’ experience in the development and manufacture of medical devices. Until recently, […]

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