The FDA acknowledged interruptions with notifications from recalling firms during the pandemic, while regulatory experts point to fewer inspections and fewer procedures.
Hinting at a future alternative to opioid painkillers, scientists have developed a tiny implant designed to ease post-surgery pain and then dissolve once the job is done.
Currently, Parkinson’s Disease (PD) diagnosis is mainly based on medical history and physical examination, and there is no objective and consistent basis. By the time of diagnosis, the disease would have progressed to the middle and late stages that it’s difficult to treat. Although there’s no cure, early diagnosis and treatment can improve one’s quality of life, relieve symptoms and prolong survival.
How machine learning is influencing “The Conversation” – Artificial intelligence (AI) is beginning to affect every aspect of our lives, including when physicians should have the conversation broaching palliative care with patients. Machine learning, a type of AI, uses statistical models and algorithms to recognize data patterns and make predictions on behalf of doctors. But how accurate is it?
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.