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The United States Food and Drug Administration (FDA) sees “appropriate” transition period for COVID-19 test EUAs when Public Health Emergency ends

April 19, 2022 Dive Brief: Toby Lowe, Associate Director for Regulatory Programs in the FDA’s Office of In Vitro Diagnostics and Radiological Health, told a virtual town hall meeting on in mid-April that the Agency is not planning “to take any actions that would leave the American public without the tests that they need.”  Lowe … Read more

Notre Dame Developing Device to Diagnose Heart Attack in Minutes

April 14, 2022 Notre Dame Sheehan Family Collegiate Professor of Engineering Dr. Pinar Zorlutuna says the standard troponin test used today is “a really delayed diagnosis.”  Troponin is the functional protein in heart muscle cells that makes them beat.  After a heart attack, the cells start dying, causing troponin to spill out into the blood.  … Read more

Researchers develop wearable device to fight opioid overdoses

April 13, 2022 However, University of Washington researchers are hopeful that a wearable device could be a big help.  They have developed a wearable injector that’s worn on the stomach like an insulin pump.  Using algorithms, it senses when the wearer stops breathing and automatically injects a medicine that rapidly reverses an opioid overdose called, … Read more

Smartphone app may help detect concussions

April 07, 2022 “Physicians have measured [pupillary light reflex (PLR)] since the earliest time of recorded history,” lead study author Frederick Robert Carrick, DC, PhD, MS-HPEd, Professor of Neurology at the University of Central Florida College of Medicine, said in a press release.  “It is only recently that advances in technology have allowed us to … Read more

Washable Fabric Measures Electrical Activity of Muscles

April 05, 2022 The fabric contains a network of silver flakes and gold nanoparticles that provide conductivity and allow electrical signals to be measured in high fidelity using a portable electromyography (EMG) device.  Physical rehabilitation is a cornerstone of recovery from a variety of illnesses and injuries, but obtaining hard EMG data on muscle activity … Read more

AI Promotes Preventive Care For At-Risk Atrial Fibrillation Patients

March 31, 2022 Massachusetts General Hospital (MGH), the Broad Institute of MIT, and Harvard researchers created an artificial intelligence-based approach to identifying patients at risk of developing atrial fibrillation, promoting prevention care.  Atrial fibrillation is a common condition that can cause clots in the heart that can then travel to the brain and lead to … Read more

FDA releases MDUFA V details after industry negotiations

March 25, 2022 If passed by Congress and signed into law, it would be the fifth version of the Medical Device User Fee and Modernization Act of 2002.  AdvaMed lauded the framework earlier in March 2022 after regulators and industry representatives negotiated updates to the program, which collects fees from applicants to fund FDA review. … Read more

Simple Color Change Test Identifies Wound Infections

March 22, 2022 The test works by detecting virulence factors released by the bacteria, which prompt a simple color change in a solution.  The test could help clinicians to determine whether to prescribe antibiotics, and may help to avoid unnecessary prescribing.  As the test can be administered at the point of care, and does not … Read more