E-nose designed to diagnose Parkinson’s disease by smelling skin

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.

Artificial Intelligence (AI) Algorithms Help Guide Decisions In Palliative Care

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?

FDA guidances for medical device regulation after enforcement discretion and EUA expiration

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.