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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.

FDA cannot explain record-low medical device recalls

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.