Australia Issues Update on Medical Device Reform September 11, 2017 The TGA reforms will enhance post-market surveillance and improve the integration of pre- and post-market activities. Read More
FDA Taking Suggestions for Regulations to be Eliminated Under Trump Policy September 11, 2017 The agency said it is looking to achieve “meaningful burden reduction” while fulfilling its public health objectives. Read More
C4 Imaging Receives Additional FDA 510(k) Clearance for its Positive-Signal MRI Marker September 8, 2017 The company assessing plans to supply Sirius for prostate cancer patients in markets outside the US. Read More
Cellectis CAR-T Studies on Hold Following Death of First Patient September 8, 2017 A data safety monitoring board recommended lowering the dose in both studies. Read More
Dextera Surgical Wins Expanded FDA Clearance for MicroCutter 5/80 Stapler September 7, 2017 The expanded indication represents an additional 44,000 procedures in the United States annually. Read More
FDA Denies Public Citizen Petition to Pull Oral Ketoconazole September 7, 2017 Public Citizen based its conclusions largely on a 2013 assessment by the FDA’s Office of Surveillance and Epidemiology. Read More
Adherium Receives FDA 510(k) Clearance for Next Generation Smartinhaler September 6, 2017 The device stores the history of patient medication usage patterns. Read More
IPRF and IGDRP Plan to Consolidate Initiatives September 6, 2017 The FDA serves as a member or observer in both organizations. Read More
Apollo Endosurgery Wins CE Mark for 12-Month Orbera Weight Loss Balloon September 5, 2017 Apollo Endosurgery said expects to begin commercialization of the Orbera365 device in the fourth quarter. Read More
Mutual Fund Sues Valeant Alleging it is a Criminal Enterprise September 5, 2017 Valeant bought more than 100 companies between 2008 and 2014. Read More
FDA Grants ExThera Medical’s Seraph 100 Blood Filter Expedited Access Pathway Designation September 1, 2017 Seraph is designed to quickly treat blood stream infections to prevent them from becoming life-threatening. Read More
Lilly to Resubmit NDA for Arthritis Drug September 1, 2017 The drug was approved this year in the European Union and Japan. Read More