Anika Therapeutics Obtains CE Mark Approval for Cingal to Treat ...
Anika Therapeutics received CE Mark approval for CINGAL® as a medical device to treat knee osteoarthritis pain.
Bone Therapeutics Reports Initial Efficacy from PREOB® Phase IIA Trial
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.
U.S. Government Extends Biomet’s Deferred Prosecution Agreement
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 Receives FDA Clearance for TX2 MicroTip to Treat Chronic ...
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 Enters Distribution Agreement with Vivex Biomedical for OsteoVive ...
Xtant Medical entered into a distribution relationship with Vivex Biomedical to commercialize OsteoVive™ viable cell allograft.
Carestream Submits FDA 510(k) Application for OnSight 3D Extremity Diagnostic ...
Carestream Health filed its FDA 510(k) application for the CARESTREAM OnSight 3D system for weight-bearing extremity imaging.
Amedica to 3D Print Silicon Nitride for Medical Applications
Amedica has fabricated its first silicon nitride structures with a 3D printing process called robotic deposition, or robocasting.
aap Implantate Divests Biomaterials Unit
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 Receives China Regulatory Clearance for Orthopaedic Imaging System
EOS imaging received regulatory approval to market the EOS 2D/3D orthopaedic imaging system in China.
Proving Medical Necessity: the Need for Evidence in Reimbursement
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.