FDA Clears MagVenture’s Device for the Treatment of Depression May 8, 2017 The MagVita TMS therapy system delivers magnetic pulses to stimulate nerve cells in the brain. Read More
FDA Warns American Specialty Pharmacy for Adulteration May 8, 2017 Inadequate responses to the agency’s observations prompted the warning letter. Read More
Crospon Recieves FDA Clearance for Endoflip with Flip Topography Module May 5, 2017 This device will allow clinicians to assess patient motility disorders during endoscopy. Read More
Petition Calls for Sentinel Query on Off-Label Use of Ulcer Drug May 5, 2017 The foundation has urged the agency to assess the risks posed by the drug. Read More
FDA Grants Clearance of Interscope’s EndoRotor May 4, 2017 The device is a flexible microdebrider. Read More
EMA Should Clarify Role in Collaboration on Non-EU Drugs, Officials Say May 4, 2017 EMA officials met with delegates to discuss the issue in a recent workshop in Malta. Read More
Luminex Receives FDA Clearance for ARIES Bordetella Assay May 3, 2017 The company has also achieved CE-IVD marking for the assay. Read More
Divi’s, Teva Draw Warnings Over GMP Problems May 3, 2017 The FDA also says Divi’s limited the agency’s inspection. Read More
FDA Grants Clearance to Medtronic’s Resolute Onyx Drug-Eluting Stent May 2, 2017 The device is designed with the transradial approach. Read More
Gottlieb Avoids Written Commitments to Recusal for 22 Companies May 2, 2017 He said he would abide by an ethics agreement he submitted in March. Read More
House Bill Would Streamline Device Accessory Approval May 1, 2017 The act would require the FDA to revise regulations for the reclassification of previously approved, low-risk medical devices. Read More
MHRA Outlines Regulatory Goals in Preparation for Leaving the EU May 1, 2017 One of its top priorities is to devise a five-year plan encompassing national and international strategies for collaboration. Read More