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As more cases are uncovered in a global monkeypox outbreak, biotech companies and health officials are looking to make PCR testing for the virus more widely available in the US.

A new study shows that implementing an artificial intelligence-based medical device in primary care settings can help clinicians accurately diagnose autism spectrum disorder in children.

This article summarizes the requirements for transitioning medical devices, marketed with lowered standards for effectiveness under emergency use authorization (EUA) during the COVID-19 pandemic, after the EUA declaration expires.  These policies may evolve as the US Food and Drug Administration (FDA) awaits declaration from the secretary of Health and Human Services (HHS) stating that the pandemic has ended.  The author suggests this limited oversight of the manufacture of medical devices and the lowered expectations for device effectiveness may affect future requirements for objective evidence for marketing submissions after EUAs have been terminated and diagnostics for COVID-19 undergo increased scrutiny by the Agency for marketing authorization.  The scope of this article covers medical devices with published enforcement discretion policies from the FDA and those authorized under EUAs during the COVID-19 public health emergency.

Gains in cognitive skills and adaptive function appear to be slower for children with low cognition and low adaptive behavior with hearing aids versus implants

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.