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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It's problematic that the FDA’s recently released device software draft guidance lacked input from the Center for Drug Evaluation and Research (CDER), two industry groups said in written comments to the agency.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
A group of drug and device companies is asking the U.S. Court of Appeals for the D.C. Circuit to toss out its recent decision to revive a lawsuit in which plaintiffs are seeking to hold the companies liable for aiding in the funding of acts of terror in Iraq. Read More
The FDA has issued final orders classifying four medical devices as Class II (special controls), and said the classification will help increase patient access to the devices. Read More
In an effort to better understand high prices for drugs and diagnostics, prominent doctors groups and other advocacy groups have called on the Biden administration to openly share the costs of clinical trials paid for by the federal government. Read More