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The Center for Devices and Radiological Health (CDRH) issued 39 final guidances in 2022, nearly doubling the 21 issued the previous year, but it was a Feb. 23 draft rule that garnered the most attention — Medical Devices; Quality System Regulation Amendments — that proposes to align the 20-year-old FDA quality system requirements (QSR) with International Organization for Standardization (ISO) requirements.
The U.S. Patent and Trademark Office has granted Reperio Health a patent for the technology that powers its biometric health screening platform that delivers home-performed medical tests to a mobile app.
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.