medical device regulation

BellaSeno’s Pioneering 3D Printing Facility for Medical Implants to Open in 2025

German 3D printing medical implant pioneer BellaSeno plans to launch a fully automated production facility in Australia by mid-2025 to make its resorbable soft tissue and bone reconstruction implants. By…

BellaSeno Receives European Authorization for 3D Printed Bone and Chest Wall Implants

Founded in 2015, German medtech company BellaSeno GmbH develops novel resorbable 3D printed soft tissue and bone reconstruction implants, and last summer announced two clinical trials for its 3D printed…

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AMS 2021: 3D Printing in Healthcare Depends on Reimbursement & Regulations

Additive Manufacturing Strategies 2021, co-hosted by 3DPrint.com and SmarTech Analysis, held its fourth summit in a virtual format. Each day focused on two verticals, with the focus first on metal…

What Medical Device Regulation Might Mean for 3D Printed Patient-Specific Implants

You would be hard pressed to find a sane member of society who would advocate for a removal of all oversight in the field of medicine. However, that doesn’t mean…