Medtech groups want more time to implement FDA’s QMSR rule

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 for treating uterine fibroids

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.

Study says Diadem blood test accurately predicts Alzheimer’s disease progression

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.

FDA recommends sponsors plan to include race, ethnicity in clinical trial design

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.