PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has undertaken a massive effort to reform its drug and device regulations, and as it pulls into the homestretch with those reforms, it is setting its sights to postmarketing efforts that include adverse event reporting, conformity assessments, patient-reported outcomes and a universal device identifier program. Read More
Genetic testing for health care purposes took a hit with the onset of the COVID-19 pandemic, but there are concerns about the volume of these tests in the four years before the onset of the pandemic. The U.S. Office of Inspector General (OIG) said recently that the data suggest possible fraud and abuse of the Medicare program, and that the picture suggests a need for a more concerted regulatory effort by the CMS. Read More
In the season of college bowl games, two long-time rivals are vying for another title, the right to claim being the first to install Siemens Healthineers AG’s Magnetom Free.Max magnetic resonance imaging (MRI) system. Both the Ohio State University and the University of Michigan said they were first in the U.S. to put in the recently approved system. Read More
Glaciers are known to move slowly, but so is government, and the FDA needed seven years to make effective an order that cerebrospinal fluid shunts be deemed class II devices. The classification was applicable as of Aug. 22, 2014, in connection with a de novo petition filed by no less than industry colossus Medtronic plc, of Dublin, in a process that began in 2012, possibly earlier. Read More
The med-tech industry across Latin America continues to grow, but the growth is uneven, concentrated in a handful of countries and faces significant challenges. A report released in December by the United Nations Economic Commission for Latin America and the Caribbean (ECLAC) reveals the complexity of the region's med-tech trade balance and underscores the main challenges for the industry in the region, whose performance was also impacted by the COVID-19 pandemic. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Conceptions, Co-Diagnostics, Idaho Molecular, Titan Medical. Read More
