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The FDA’s supervision of device safety is in the congressional crosshairs following last June’s recall of Medtronic’s HeartWare Ventricular Assist Device (HVAD) System. Read More
New employees with responsibilities in the quality assurance, quality control and manufacturing departments should be trained on current good manufacturing practice (cGMP) requirements for the type of product they are producing. These procedures should include proper gowning technique, cleanroom behavior, and introduction to contamination control and good documentation practices. Read More
The FDA is considering how to offer more regulatory flexibility for medical device software, said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH). Read More
ResApp Health has touted positive study results showing its smartphone, audio-based COVID-19 screening test correctly detected the coronavirus in 92 percent of infected people. Read More
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
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