Tag Archive for: medical device

Biocomposites launches SYNICEM™ spacers in the U.S.

Ready-to-use preformed antibiotic loaded spacers for hip, knee and shoulder revisions Choice of Charnley and Müller hip spacer designs, and left and right geometries for each knee Keele, UK, 21 October 2025 – Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for use in infection management in bone and […]

ViCentra Raises $85M to Scale Manufacturing and Accelerate Market Penetration of Kaleido Insulin Patch Pump

Led by new investor Innovation Industries, with matching contributions from existing investors, Partners in Equity and Invest-NL, the $85M round also drew support from EQT Life Sciences and Health Innovations, demonstrating strong confidence in ViCentra’s next phase of growth Fresh capital fuels scale-up, regulatory pathway, and commercialization of Kaleido 2, the world’s smallest, lightest, and […]

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

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 […]

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

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 […]

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

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 […]