Month: March 2026

Personalized immunotherapy enters human trials: A personalized immunotherapy developed at Colorado State University (CSU) that extended the life of a dog with cancer is set to begin human trials. The immunotherapy uses a patient’s own inactivated tumor cells to train the immune system to recognize and attack the cancer, and a clinical trial at City of Hope in California will involve patients with recurrent ovarian cancer.

A Management Review is meant to be one of the most strategic tools in a management system. It brings leaders together to reflect on performance, understand the state of the system, and make changes to benefit the system. Yet, too often, these meetings become predictable. Data is at times “massaged” to give leadership a warm and fuzzy feeling.

The European Commission (EC) has proposed targeted reforms aimed at simplifying rules for medical devices. The proposed reforms are part of a package of measures put forth by the Commission in December 2025 to advance the biotechnology sector, enhance access to cardiovascular treatments, and streamline medical device regulations.

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.