FDA 510(k) clearance
LuxCreo Targets Medical Sector with FDA-Cleared 3D Printed Sleep Apnea Devices
Application-focused additive manufacturing firm LuxCreo is now moving beyond dentistry to tackle the medical device space. To do so, the company has partnered with EMA Sleep, Inc. to enhance the…
Formlabs Advances its Dental 3D Printing Capabilities with FDA Approval and Open Material Mode for Form 4
As the company continues to grow in the dental 3D printing segment, Formlabs has announced that its Premium Teeth Resin has received FDA 510(k) Medical Device Clearance. The material was…
3D Systems Brings 3D Printed PEEK Cranial Implant to the U.S. with FDA Clearance
For more than 10 years, 3D Systems (NYSE:DDD) has worked hand-in-hand with surgeons to plan over 150,000 patient-specific cases, and develop more than two million instruments and implants from its…
FDA Approves Patient-specific Radiation Therapy Devices
Radiation treatment is a crucial aspect of contemporary medicine, with half of all cancer patients undergoing it. By directing X-ray or proton beams at a tumor, it’s possible to halts…
