GAITHERSBURG, Md. – The Nov. 13 U.S. FDA hearing on immune response to metal-containing implanted medical devices suggested that there are many more questions than answers about how to prevent the associated adverse events. However, a key hurdle is the absence of widely recognized tests for determining patient sensitivity to these metals.
Australia's Therapeutic Goods Administration (TGA) recently posted a draft guidance for regulation of software as a medical device, but the Medical Technology Association of Australia expressed a preference for an international standard for risk classification.
Marlborough, Mass.-based Hologic Inc. got good news from the U.S. FDA, which has given the green light for the 3Dquorum imaging technology, which employs Genius AI. The technology works along with Hologic's Clarity HD high-resolution imaging technology to reduce tomosynthesis image volume for radiologists by 66%, the company said.
Nanthealth Inc. has received U.S. FDA clearance for a whole exome sequencing test to determine overall tumor mutational burden (TMB) in cancer tissue. Known as Omics Core, the first-of-its-kind in vitro diagnostic test is available now as part of Nanthealth's GPS Cancer molecular profiling suite.
Advocates of telehealth are backing the bipartisan, bicameral Connect for Health Act of 2019, which would eliminate geographic and origination site restrictions on Medicare coverage and save billions of taxpayer dollars.
The U.S. FDA's two-day advisory hearing on industrial ethylene oxide (EtO) sterilization of medical devices wrapped up with a discussion of how duodenoscopes can be made safer. The conclusion was largely that employee churn, training and work conditions were the biggest challenges – issues over which the FDA has nearly zero leverage.
The first day of the FDA's two-day hearing on ethylene oxide (EtO) sterilization of medical devices addressed several alternatives to EtO, but the advisory panel had little advice to offer the agency other than to encourage tweaks to sterilization procedures in order to get past the immediate problem.
RSS
