Despite two (2) decades of consistent FDA Warning Letter patterns, medical device companies continue making the same compliance mistakes with CAPAs, Design Controls, and complaints accounting for over one-third (1/3) of all citations.
A study published in Med examines the case of a 33-year-old man who was kept alive for 48 hours without lungs by connecting him to an external artificial-lung system that maintained normal blood flow through the heart until a double lung transplant could be performed. The system was originally developed to support critically ill COVID-19 patients and could offer a temporary lifeline for other critically ill patients awaiting transplant. There have been no signs of organ rejection or impaired lung function in the patient nearly three (3) years later.
Researchers said they have uncovered a novel sign of chronic stress and its damaging effects on the body by using an artificial intelligence algorithm to analyze common CT scans for what they describe as a “biological barometer.”
Greying hair might be a sign of anti-cancer defense: A study in Nature Cell Biology revealed that greying hair might be a byproduct of the body’s defense against cancer. Working with mice, researchers found that pigment-producing cells shut down when their DNA experiences double-strand breaks, preventing the spread of mutations. Over time, this leads to fewer pigment cells and grey hair.
MDR (the European Union [EU] Medical Device Regulation), MDSAP (the Medical Device Single Audit Program), and FDA Inspections demand rigorous preparation, lifecycle traceability, and risk-based compliance for global market access.
In a move meant to bolster the adoption of Artificial Intelligence (AI)-enabled digital health products, the US Food and Drug Administration (FDA) in January 2026 updated two guidance documents to ease its oversight of general wellness devices and Clinical Decision Support (CDS) software.
The International Medical Device Regulators Forum (IMDRF) has outlined its vision for the next five (5) years, which includes further engagement with the medtech industry to ensure promising products reach patients quickly. The group also plans to reform its governance structure as it continues to grow its membership to ensure long-term sustainability.
A study in Nature Communications found that long COVID follows eight (8) symptom trajectories, varying in severity and duration. Researchers tracked 3,700 adults and found 10% developed long COVID, with 81% of those still having symptoms a year later. “The variability we identified will enable future studies to evaluate risk factors and biomarkers that could explain why patients vary in time of recovery, and help identify potential therapeutic targets,” said lead researcher Tanayott Thaweethai.
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.