The U.S. FDA has finally unveiled the fifth edition of the device user fee program (MDUFA V), and some of the performance measures remain unchanged from MDUFA IV, such as that the FDA will process 95% of 510(k) filings within 90 days.
For patients with complex fractures, bone lost to cancer or trauma and those undergoing spine surgeries, the fear of incomplete or distorted bone growth remains an acute and well-founded concern. Read More
The FDA cleared a peripheral vascular occlusion product developed by Artio Medical Inc. The Solus Gold embolization device is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.
Broncus Holding Corp.’s thermal vapor treatment system Intervapor has won approval from China’s NMPA. The system is used for the treatment of chronic obstructive pulmonary disease (COPD), lung cancer and other pulmonary diseases. Read More
Citing a court order for its haste, the U.S. FDA skipped the draft and went straight to issuing a final guidance that will change how certain ophthalmic drugs are regulated. Read More
Patent law cases are known for lengthy, intricate arguments and explanations, but a recent decision by the U.S. Court of Appeals for the Federal Circuit flew against this trend.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Boditech, Exagen, Heartpoint Global, Helix, Indegene, Kenetic River, Metame, Proscia, Rosalind, Thermo Fisher, Visopharm. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Artio Medical, Cerus Endovascular, SIS Medical. Read More
