FDA Approves iCAD’s PowerLook Tomo Detection Device March 27, 2017 The device also identifies suspicious areas that radiologists may not see initially. Read More
China Looks to Change Import Drug Registration System March 27, 2017 The proposal does not apply to vaccines. Read More
Mirabilis Medical Wins CE Mark for Uterine Fibroids March 24, 2017 This clearance was accomplished after the company completed their first clinical trial. Read More
VistaPharm Cited for Contamination, Other Violations March 24, 2017 The company detected contaminants in purified water used to manufacture a variety of oral liquid drug products. Read More
FDA Grants Marketing Clearance to Icare HOME Tonometer March 23, 2017 The device is intended to assist clinicians and patients to monitor glaucoma 24/7. Read More
Four Former FDA Commissioners Advise Against Drug Importation March 23, 2017 Commissioners argued imported drugs could be substandard, adulterated or fake. Read More
European Union Grants CE Mark to Nucleix's Bladder EpiCheck March 22, 2017 The device includes a panel of 15 proprietary biomarkers. Read More
Sanders, Cummings Request Info on FDA’s Emflaza Approval March 22, 2017 Emflaza is an internationally used corticosteroid treatment that no longer carries patent protections or market exclusivity in the U.S. Read More
MHRA Issues Guidance on Leadless Pacemaker Clinical Studies March 21, 2017 MHRA says manufacturers should work to minimize bias and make inherent design limitations explicit. Read More
House E&C Committee Leaders Seek Additional Info on FDA’s Heparin Investigations March 21, 2017 The documents are expected to provide the committee with further insights into the crisis. Read More
Masimo Gains CE Mark for Rad-97 Pulse CO-Oximeter and Connectivity Hub with Noninvasive Blood Pressure March 20, 2017 The device enables clinicians to measure arterial blood pressure for adult, pediatric and neonatal patients. Read More
Patent Office Affirms Four of Acorda’s Patents on MS Drug Ampyra Pending Court Ruling March 20, 2017 The patent office said there is not adequate support to challenge Acorda’s patents. Read More