Cochlear Shares Jump on FDA Nod for Nucleus 7 Sound Processor June 22, 2017 The N7 sound processor has prompted a rise in shares to 3.9 percent Read More
Malaysia Issues New Mandatory Device Reporting Requirements June 21, 2017 The new reporting criteria were designed to better delineate the seriousness of problems associated with medical devices. Read More
South Africa New Device Regs Are Now Live June 21, 2017 The agency began grandfathering devices and IVDs into the new system in February. Read More
J&J, Medtronic Knock TGA’s Device Review Plan June 21, 2017 Companies say plan could exclude technologies with limited data. Read More
Medical Device Electrodes Market Projected to Reach $2 Billion By 2025 June 21, 2017 The bulk of the growth will occur in North America. Read More
Australia’s TGA Strikes Harder on Follow-up Inspections, CAPA Deficiencies June 20, 2017 Facilities will face tougher scrutiny after third strike. Read More
FDA Pilot Will Use Third-Party Certification to Speed Digital Devices to Market June 20, 2017 Gottlieb announces effort as part of broader agency goals to regulate digital health. Read More
India to Open $6 Million Medical Device 3D Printing Facility June 20, 2017 Indian government aims to increase domestic device production. Read More
Stryker Buys Canadian Imaging Company for $701 Million June 20, 2017 Medical devicemaker aims to focus more on visualization. Read More
FDA Grants UDI Labeling Extension to Lower-Risk Devices June 19, 2017 Class III devices already required to comply. Read More
FDA Will Issue Tougher Validation Requirements for Reusable Devices June 19, 2017 Notice follows epidemics due to tainted duodenoscopes. Read More
One in Three Heart Surgery Temperature Control Devices May Be Contaminated June 19, 2017 Major device manufacturer to modify design, offer free deep infection service. Read More