2018 3D Printing Medical Application Highlights (2)

2018 3D Printing Medical Application Highlights (1)
June 29, 2018
Two Invoice Policy Will Reshape China Distribution Landscape (1)
July 12, 2018

2018 3D Printing Medical Application Highlights (2)

Medical implants

The 3D printed titanium mesh implant promotes bone regeneration

In the medical field, the treatment of large bone defects or injuries remains a thorny field. But research teams from the Charité Musculoskeletal Surgery Center have demonstrated that they can treat large bone defects by designing and manufacturing custom 3D printed stents. This method uses a CT scan of the patient’s skeleton and the medical team generates a 3D model of the defective bone. This 3D printed structure is crucial for promoting bone regeneration. So far, the Charité Musculoskeletal Surgery Center has implanted custom 3D printed bone scaffolds into a total of 19 patients, and all of whom showed good hopes of healing. Currently, the cooperation team is designing and producing a soft, mechanically bio-optimized titanium mesh stent using 3D printing technology. The team said that its technology would even be used to treat spine, mouth and maxillofacial defects.

 

For the summary of the CFDA 3D printing device draft guideline, please click Here. For the complete English version of the guideline, please email info@ChinaMedDevice.com.

China Med Device, LLC and CABA held a regulatory event on 3D printing with CFDA representatives in 2017 December. For the presentation from the CFDA director, please also email us.

 

German EIT Emerging 3D Print Implants Approved by FDA

Emerging Implant Technologies (EIT) was the first medical device manufacturer to focus on the use of additive manufacturing implants in the orthopedics sector. It specializes in the treatment of spinal diseases with 3D printed implants, and the technology is outstanding in the industry. Last year, the Celluluar Titanium Spinal Implant was approved by the U.S. Food and Drug Administration (FDA), and now EIT has received FDA approval. It is understood that this expansion of the EIT Cellular Titanium application can be used for multiple consecutive levels of cervical spine (C2 To T1). Spinal disease has been difficult to treat. The company’s Cellular Titanium implants cannot only replace but also help re-grow bones, leading to faster, more complete healing of patients. In addition, EIT has more innovative products to enter the market. In the second quarter of this year, the company plans to add a lateral lumbar cage to its product portfolio and add a fully 3D printed lateral expansion cage in the fourth quarter.

 

For regulatory and commercialization services on China 3D printing market, please email info@ChinaMedDevice.com.

 

About China Med Device, LLC  

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 200+ companies’ success.