FDA warns that some prenatal screening tests can generate false results

April 29, 2022 The growing – and sometimes inappropriate – use of these tests prompted the warning, according to FDA.  These tests, which fall under the category of laboratory-developed tests (LDTs), are not subject to premarket review by FDA and are accorded enforcement discretion under the Medical Device Amendments of 1976. “While genetic non-invasive prenatal … Read more

UCF researchers develop new rapid test to detect viruses like COVID-19

April 26, 2022 Researchers at the University of Central Florida (UCF) in the US have developed a device to identify viruses, such as COVID-19, in the human body as quickly as rapid detection tests.  The new device has a 95% accuracy rate for determining if a person carries a virus, a claim that matches the … Read more

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