Lori A Carr May 11, 2022 Illinois Institute of Technology (IIT) lab looks like a workshop full of stitching and spinning. Gold wire circles the perimeter of each device assembled. Combined, the tiny components have big promise. They are designed to help the blind see…something. It is a challenge Dr Philip Troyk and his research team have been … Read more
May 04, 2022 On 9 August 2021, FDA published a notice announcing its implementation of a court decision in Genus Medical Technologies LLV v. FDA (Genus) and requesting public comment. The notice states that in accordance with the Genus decision, FDA “intends to regulate products that meet both the device and drug [emphasis original] definition … Read more
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
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
April 22, 2022 People can wear a prosthetic eye for various reasons. For instance, someone may wear it if their eye did not develop normally or if they had an accident or had to have it removed because of cancer. A prosthetic eye is actually quite a common treatment for patients who have lost an … Read more
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
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
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
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
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