Every quality professional knows the feeling — that sudden jolt of anxiety when an audit notification hits the inbox. Despite robust systems, documented Standard Operating Procedures (SOPs), and periodic training, many organizations still scramble when Auditors come calling. The truth is simple: audit panic is a symptom, not a cause. It signals a gap between the Quality Management System (QMS) and what is lived daily.
Over the past year, industry has been seeing a pattern in several FDA interactions that are worth talking about openly…one professionals opinion…
Cognitive fatigue is being studied more intensively due to its prevalence in conditions such as long COVID, chronic fatigue syndrome, and multiple sclerosis, with researchers developing better biomarkers, behavioral tools and potential treatments. Leading theories suggest that when the brain engages in sustained, effortful thinking such as complex problem-solving or navigating unfamiliar situations, demands on neural circuits may deplete cellular energy or allow metabolic waste products like glutamate to accumulate, triggering fatigue as a protective signal to rest.
The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions.
Market growth for surgical robotics is driven by aging populations, Artificial Intelligence (AI) advances, and demand for minimally invasive procedures that reduce complications and improve outcomes.
10-year-old saves father with stem cell donation: A 10-year-old boy became the youngest stem cell donor at Cedars-Sinai Medical Center (California) after choosing to donate stem cells to his father, a doctor battling a fast-recurring form of acute myeloid leukemia. The transplant succeeded, with tests showing 99% of the father’s cells now come from his son. “He donated six million stem cells to save my life, so it’s not just an honor to call him my son, I’m proud to call him my hero,” said the father.
Uterine Fibroids Linked To Women’s Heart Disease Risk: An analysis of data from more than 2.6 million women, published in the Journal of the American Heart Association, associated uterine fibroids with an 81% higher risk of heart disease over 10 years. Women younger than age 40 had the highest risk. Researchers said from 20% to 80% of women could develop fibroids by age 50.
For decades, dreary winters have sent people running to the tanning salon to get that summery golden glow. In the United States (U.S.) alone, estimates suggest 30 million people get bronzed each year. However, tanning beds are also potent carcinogens, since their intense doses of Ultraviolet (UV) rays can penetrate skin cells and cause DNA mutations. Now, scientists have determined just how dangerous tanning salons can be.
Lumos Labs has obtained a clearance from the FDA for its popular Lumosity brain training platform, greenlighting a version of it to be marketed as a prescription digital therapeutic for adults with Attention – Deficit/Hyperactivity Disorder (ADHD) for the first time.
The United States Food and Drug Administration (FDA) has approved its first at-home, nondrug therapy for depression, with a wearable brain stimulation headset developed by Flow Neuroscience (Flow).