Data from a clinical validation study published in the Journal of Prevention of Alzheimer’s Disease (AD) show that Diadem’s AlzoSure Predict Alzheimer’s disease blood test was able to accurately predict the progression of the disease. The researchers compared the test, which has been designated a breakthrough device by the FDA, with gold-standard amyloid beta-PET imaging.
In England, 5,000 patients die each year from antibiotic-resistant super bugs. Scientists at Imperial College London have developed a new rapid diagnosis test. Superbugs spread rapidly and often kill patients admitted for minor problems.
The US Food and Drug Administration (FDA) is recommending sponsors include a plan to increase diversity when proposing clinical trial designs for investigational products to Agency reviewers. The move is part of the Biden administration’s focus on addressing racial and ethnic disparities in health care.
Researchers at the Massachusetts Institute of Technology’s (MIT) Lincoln Laboratory have developed an artificial intelligence-guided ultrasound device to help physicians quickly deploy a catheter at a point of injury.
Experts are on the cusp of breaking access barriers with the development of mobile magnetic resonance imaging.
Medical device product recalls were down 14.3% in the federal government’s fiscal year 2021, according to a recent Medical Design & Outsourcing (MDO) analysis of recall data.
Collaboration, communication, and education can help healthcare organizations manage medical device security challenges and ensure patient safety.
Researchers at Washington State University have developed an electrochemical test that can rapidly identify antibiotic-resistant bacteria in patient samples.
Device serves up “potentially negligible” benefits for people without diabetes
Researchers at MIT have created a surgical tape that can seal leaks and tears in the intestine. The off-the-shelf product has been designed to replace sutures, which are difficult to sew in the gut and can cause scarring or leaking.