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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.
The FDA started the year with a soft launch of its Total Product Life Cycle Advisory Program (TAP) pilot, with the intention of enrolling up to 15 devices in fiscal 2023.
Pediatric use of medical devices “requires considerations such as growth and development, anatomical and physiological differences, hormonal influences, and activity level,” the NCC-PDI says.