MÖLNDAL, Sweden--(BUSINESS WIRE)--Regulatory News:
Arcam AB (STO:ARCM), listed on NASDAQ Stockholm, and leading supplier of Additive Manufacturing solutions, announces that a new hip system from Beijing AK Medical is now formally approved by the Chinese State Food and Drug Administration. This is China's first CFDA marketing approval for an additively manufactured orthopedic implant.
Beijing AK Medical, a Chinese orthopedics implant industry leader, and Professor Zhongjun Liu and Professor Ke Zhang of Peking University Third Hospital have been working closely together on this project. After six years of product design, biological tests, biomechanics and clinical validations, and regulatory approval processes, the 3D ACT hip system has finally received marketing authorization.
“We are very happy that our customer Beijing AK Medical received this first ever CFDA approval for an Additively Manufactured implant in China. This confirms how our EBM technology is leading the way in additive manufacturing of implants”, says Magnus René, CEO of Arcam.
“With this CFDA approval in place we look forward to a continued strong growth in the Chinese market”, says Jane Chen, General Manager of Arcam (Beijing) Industrial Equipment Ltd.
Arcam Group provides cost-efficient Additive Manufacturing solutions for production of metal components. Arcam’s Electron Beam Melting (EBM®) technology offers design freedom combined with excellent material properties and high productivity. Arcam is, through its solution orientation and comprehensive product offering, an innovative partner for advanced manufacturing, primarily for the aerospace and medical industries. Arcam offers EBM systems through Arcam AB in Sweden, powder metals through AP&C in Canada and implant contract manufacturing through DiSanto in the U.S.The company is listed on Nasdaq Stockholm and the Head Office is located in Mölndal, Sweden.
Arcam AB • Krokslätts Fabriker 27A • SE-431 37 Mölndal, Sweden • 46-31-710 32 00 • www.arcam.com
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