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With user fee legislation now firmly in place, a new Congress ready to begin legislating in 2023, and an omnibus package signed into law funding the FDA for another year, we talked with Steven Grossman, executive director of the Alliance for a Stronger FDA, about the big issues that face the agency as we head into the new year.
Know Labs has gained a patent for its “High Performance Glucose Sensor,” which the company plans to use to create the first non-invasive glucose monitor.
Israel-based portable dialysis devicemaker liberDi has received FDA clearance for its Digital Dialysis Clinic, which allows patients to have dialysis at home while being monitored by a telemedicine provider.
Medical device distributor Jet Medical has agreed to pay $200,000 in criminal penalties to settle allegations that it misbranded its Allevio SPG nerve block catheter as a migraine device.
Devicemakers can request an exemption to submit adverse event data from real-world data (RWD) sources in formats other than the FDA’s electronic reporting format, the agency said in an update of its web page on medical device report (MDR) exception requests.
The FDA has updated its Recognized Consensus Standards database, known as “List 59,” with several new standards as well as revisions to three existing standards.