Quidel Awarded PMDA Approval for Its Sofia Influenza A+B Assay May 25, 2017 Sofia analyzer and Sofia influenza A+B FIA uses software and fluorescent chemistry to yield results. Read More
TGA Pulls Philips’ IntelliVue MX40 Patient Monitors May 25, 2017 The monitors are worn by patients in hospitals to record and generate alarms. Read More
CFDA Sees Increase in Adverse Event Reports May 24, 2017 The majority of adverse events were reported by medical institutions. Read More
TGA Investigates Heater-Cooler Devices May 24, 2017 Some heater-cooler devices have been withdrawn from the Australian market. Read More
SCIEX Gains FDA Clearance for Vitamin D Assay Kit for Mass Spectrometry May 24, 2017 The assay is intended for in vitro diagnostic use. Read More
Soterix Medical Gains FDA Clearance for IontoDC System May 23, 2017 The device is used to direct current to introduce ions of soluble salts to the body. Read More
Avacen Medical Wins CE and Health Canada Approval for Pain Treatment Device May 23, 2017 The device infuses heat into the circulatory system to provide muscular relaxation. Read More
EMED Technologies Wins Expanded Indication for Syringe Infusion System May 23, 2017 The device administers human plasma-derived immunoglobulin biologics. Read More
Otsuka and Proteus Digital Health Resubmit Application to FDA for Digital Medicine Device May 23, 2017 The FDA requested additional information, including further human factors investigations. Read More
Former Gottlieb Colleagues Offer Clues to His Management Style, Goals May 22, 2017 Gottlieb is likely to approach change at the agency with an a economist’s eye. Read More
Device Firms Issue Advisories Following Ransomware Attack May 22, 2017 Siemens said it is developing patches for medical devices that may have been affected. Read More
ORA Reorganization Includes New Geographic Divisions for Devices May 22, 2017 The previous regional configuration will be replaced with separate divisions. Read More