Medical device lobby groups say they support the US Food and Drug Administration’s plan to align its Quality System Regulations (QSR) with the international quality system standard, but they want more than a year to make the transition.
A call to action in the journal Reproductive Sciences hopes to empower health care providers to optimize their quality of care for women with uterine fibroids by relying on the best available evidence and best patient-centered practices.
Babies who are in the neonatal intensive care unit or NICU are at risk for dehydration and electrolyte imbalances and are therefore often subjected to blood draws multiple times a day. A wireless, bioelectronic pacifier could eliminate the need for invasive, twice-daily blood draws to monitor babies’ electrolytes in NICUs.
AdvaMed executive Abby Pratt has joined the Executive Committee for the Biden Administration’s Joint Supply Chain Resilience Working Group, the MedTech industry association said in mid-May 2022.
Former FDA Chief Digital Health Officer of Global Strategy and Innovation Bakul Patel has started a new job with Google after 13 years with the regulatory agency
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.