Anika Therapeutics received CE Mark approval for CINGAL® as a medical device to treat knee osteoarthritis pain. 

Initial 12-month efficacy results from a Phase IIA trial demonstrate positive effects on pain and osteoporosis blood markers from a single administration of Bone Therapeutics' PREOB® autologous osteoblastic cell therapy.

Zimmer Biomet announced that the U.S. DOJ and SEC are continuing evaluation of the company's past conduct in Brazil and Mexico, regarding possible violations of the Foreign Corrupt Practices Act.

Tenex Health received FDA 510(k) clearance to market the TX2 MicroTip, with application to treat tendinosis of the shoulder and hip in an outpatient procedure. Launch is slated for mid-2016. 

Xtant Medical entered into a distribution relationship with Vivex Biomedical to commercialize OsteoVive™ viable cell allograft.

Carestream Health filed its FDA 510(k) application for the CARESTREAM OnSight 3D system for weight-bearing extremity imaging.

Amedica has fabricated its first silicon nitride structures with a 3D printing process called robotic deposition, or robocasting.

aap Implantate sold its biomaterials unit to an undisclosed private equity firm for 36MM (~US $40.3MM). Upon closing, aap will proceed as a pure-play trauma entity.

EOS imaging received regulatory approval to market the EOS 2D/3D orthopaedic imaging system in China.

ORTHOWORLD Members of all stripes-providers, OEMs and suppliers-say that they've been impacted by complexities in the reimbursement system. One theme-that is not new, but a necessary reminder-is that the sooner a company includes reimbursement in their commercialization preparations, the better-armed they are for market entry.