The FDA’s Safer Technologies Program, or STeP, is part of an overarching emphasis on safety, and the related draft guidance focuses largely on the process of applying for a STeP device. However, a member of the FDA staff said on a webinar that device accessories – and devices that make other devices safer – are also eligible for the program.
An FDA advisory panel struggled at times to give the agency clear advice on the role of materials in device failures, but the panel nonetheless lent its support to the notion that device makers should disclose all materials used to fabricate device implants in product labels.
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.
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.
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.
The U.S. FDA has approved the Senza Omnia Spinal Cord Stimulation (SCS) system from Redwood City, Calif.-based Nevro Corp. The system is the first such system that delivers Nevro's high frequency 10,000 Hz stimulation, known as HF10, but also all other therapeutic spinal cord stimulation frequencies.
How much Senate Democrats oppose President Donald Trump's new nominee to take over the reins of the FDA could depend on whom they dislike or distrust more – Stephen Hahn, the nominee, or Brett Giroir, who just became the new acting FDA commissioner.
The new draft guidance for clinical decision support (CDS) software is in part a response to the 21st Century Cures Act, and the FDA Bakul Patel said on a Nov. 4 webinar, "we heard the feedback loud and clear" on the previous draft, and thus the agency must "get this policy to a place where it balances patient safety" and the need to avoid unnecessary roadblocks between developers and the market.
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