Materialise said today that FDA has provided 510(k) clearance for its Mimics Enlight — a cardiovascular procedure planning software creating accurate 3D printed heart models. The Belgian 3D printing software and services company, which has its U.S. offices in Plymouth, Minn., plans the first release of the software to focus on planning for complex transcatheter […]
Materialise touts FDA first in clearance of 3D printed anatomical model tech
Materialise said today it won FDA 510(k) clearance for its Mimics inPrint software designed for 3D printing anatomical models for diagnostic use, touting it as the first clearance of its kind. The Belgian company said that last August, the FDA ruled that software designed to create files for 3D printing patient-specific anatomical models for diagnostic purposes […]
Siemens Healthineers, Materialise ink 3D printing deal
Siemens (NYSE:SI) Healthineers and Materialise today announced a 3D printing deal looking to place Materialise’s Mimics inPrint 3D printing software in hospitals globally. Through the deal, hospitals and radiologists will be able to acquire the Materialise Mimis inPrint software through Siemens Healthineers’ Syngo.Via open application platform, the companies said. “We believe 3D printing is going to revolutionize the medical […]
3D printing can give your medtech startup a competitive edge
You need to be fast and nimble to compete. A strong maker culture enabled by 3D design and 3D printing could be the way to do it. Derek Mathers, Worrell It can be a lonely world for medical and biotechnology startup entrepreneurs during the early days. Despite their deep desire to introduce and scale novel life-extending […]
Johnson & Johnson gets in on 3D printing with Materialise deal for titanium skull & face implants
Johnson & Johnson (NYSE:JNJ) said this week that it inked a deal with 3D printing shop Materialise for titanium craniofacial implants customized to individual patients’ anatomies. Leuven, Belgium-based banner printing will print the Trumatch line of implants for J&J’s DePuy Synthes business, for treating patients with disorders of the face and skull. The companies have worked together on […]
Materialise NV, Canon ink Japanese distro deal
Materialise (NSDQ:MTLS) said today it inked a distribution deal with Canon (NYSE:CAJ) Lifecare Solutions to distribute its Materialise Mimics Innovation software and care suits in Japan. Through the agreement, workstations and 3D printers offered by Canon Lifecare Solutions will be offered with Materialise’s open software solutions, including the newly launched Materialise Mimics inPrint designed to allow hospitals to […]
FDA denies Materialise’s 510(k) bid for knee guide
Belgium-based additive manufacturer and 3D printing company Materialise (NSDQ:MTLS) said the FDA sent it a “not substantially equivalent” letter for its X-ray knee guide system, dooming its bid for 510(k) clearance from the federal safety watchdog. The Materialise system is designed to help align total knee replacement components without MRI or CT scans, the company said. […]
Tissue Regeneration System, Materialise ink deal to print tracheal splints
Belgium-based additive manufacturer and 3D printing company Materialise said today it inked a deal with Tissue Regeneration Systems to create 3D-printed tracheal splints for use in clinical trials. Materialise said its Mimics Innovation Suite was used to design the stent, constructed from a bioresorbable platform licensed to TRS from the University of Michigan in 2007. […]
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