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Researchers from the University of California San Diego (UCSD) have taken a concert hall sound diffuser and used it to develop an ultrasound device that treats conditions in the brain, such as epilepsy. Read More
Italian diagnostics startup Diadem has released study data indicating that its AlzoSure Confirm blood test can accurately identify patients with early Alzheimer's. Read More
Analysis of the tests is limited to laboratories designated by Quest Diagnostics that meet the requirements to perform high-complexity tests. Read More
Unimicro Medical Systems has been sent an FDA warning letter for failing to comply with the agency’s Quality System Regulation (QSR) in manufacturing needles used in laparoscopic surgery. Read More
After a long delay, the FDA said it has finally reached an agreement with medical device representatives on proposed recommendations for the fifth reauthorization of the Medical Device User Fee Act (MDUFA). Read More
Two European devicemaker trade groups, one German and the other French, have joined the chorus calling on the European Union to postpone implementing its Medical Device Regulation (MDR), which took effect May 26, 2021, with a three-year transitional period that will end May 26, 2024. Read More
In a trial, the device demonstrated 89 percent accuracy compared with the standard of care, an invasive heart catheter to measure pulmonary capillary wedge pressure. Read More