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The best way for Congress to help the FDA address its concerns about reports of a high level of false-positive results from noninvasive prenatal testing (NIPT) is to pass new legislation, the FDA said in a Feb. 11 letter to lawmakers. Read More
San Francisco, Calif.-based Sirona Medical has acquired two FDA-cleared products from Nines, another California radiology software developer, expanding its portfolio of products that use artificial intelligence (AI) for analysis of radiographic images. Read More
The FDA has released its long-awaited proposed rule that aims to harmonize the agency’s Quality System Regulation (QSR) with the International Organization for Standardization (ISO) 13485 standard. Read More
UK-based Parasym’s neuromodulation device significantly improved cardiac mechanics and inflammation in heart failure patients in a clinical trial at the University of Oklahoma. Read More
Devices and replacement parts that are “printed” using new three-dimensional printing technologies must meet the same quality benchmarks as traditionally manufactured devices, trade groups emphasized in written comments to the FDA. Read More
It's problematic that the FDA’s recently released device software draft guidance lacked input from the Center for Drug Evaluation and Research (CDER), two industry groups said in written comments to the agency. Read More
The UK’s National Institute for Health and Care Excellence (NICE) has recommended several diagnostic devices for use in biopsies for suspected prostate cancer. Read More
The FDA doesn’t want any part of regulating the “sanitation tunnels” that have popped up in certain commercial settings as a response to the COVID-19 pandemic. Read More
The White House Office of Management and Budget (OMB) signed off late last week on the FDA’s proposed rule to harmonize its Quality System Regulation (QSR) with the International Organization for Standardization (ISO) 13485. Read More
The EU and its member states must take urgent action to increase the number of notified bodies authorized to certify devices under the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) that goes into effect May 26. Read More
The FDA would be able to use outside evaluators to speed authorizations of in vitro diagnostic tests needed to identify the pathogens causing future pandemics if a bill pending in the Senate is enacted into law. Read More