Blog Articles

Modern medicine, rooted in evidence-based practices, often dismisses the therapeutic potential of placebos due to ethical concerns. However, recent research, highlighted in Jeremy Howick’s book “The Power of Placebos,” challenges this perspective. The placebo effect, demonstrated through fake treatments like sugar pills, has proven to significantly improve symptoms in patients. Despite its effectiveness, ethical dilemmas have limited the use of placebos in routine medical practice.

Becton Dickinson (BD)/CareFusion 303 has issued a Class I recall for Alaris Infusion Pumps due to compatibility issues with Cardinal Health Monoject syringes. The recall, initiated on September 15, 2023, is a correction for product labeling rather than a removal. The FDA has identified it as a serious recall, as the use of these devices may result in serious injuries or death.

The article discusses a new study revealing that hospitalized patients who died or were transferred to the ICU experienced diagnostic errors almost 25% of the time, with most errors causing harm. The findings highlight the common occurrence of human errors in medicine and raise concerns about patient safety in hospitals.

A recent study published in Frontier Immunology highlights concerns about the long-term impact of COVID-19 mRNA vaccines on cellular immunity. The research focused on individuals receiving a fifth vaccine booster dose and found that while most maintained strong antibody responses, cellular immunity, crucial for preventing severe COVID-19, weakened in many cases. Specifically, after the fifth dose, only half of the participants retained strong cellular immunity.

The U.S. Centers for Disease Control and Prevention (CDC) has revealed that the JN.1 variant of COVID-19 now constitutes over 60% of all cases in the United States. This represents a significant increase from the estimated prevalence of 44% just two weeks prior. The variant, more common among international travelers, is also dominating in Europe and experiencing a sharp rise in Asia.

The safety notice, released on January 4, 2024, highlights significant modifications made to components of Synovo’s system, raising concerns about the safety and effectiveness of the product. This warning follows a letter sent to Synovo in March 2023, where the FDA discovered substantial changes to the femoral resurfacing cup, a part of the system, since its initial 510(k) clearance in 1991.

A recent clinical trial published in The Lancet Infectious Diseases highlights the potential of an oral gut microbiome formula, SIM01, in effectively alleviating various long COVID symptoms. Long COVID, characterized by lingering symptoms lasting weeks to years after COVID-19 infection, affects millions globally.

US-based manufacturing company AnX Robotica has received FDA de novo clearance for its AI-assisted endoscopy tool, NaviCam ProScan. The tool utilizes a deep learning algorithm called convolutional neural networks (CNNs) to identify and differentiate healthy tissue and abnormal lesions in small bowel capsule endoscopy (SB-CE) images.

The FDA closed out 2023 with rejections of three drugmaker applications for first approval or expanded use, issuing complete response letters to Amgen, Zealand Pharma, and Merck & Co. The rejected drugs were intended for treating cancer, low blood sugar, and chronic cough. Despite these setbacks, the FDA’s main review office approved 55 new drugs in 2023, the highest since 2018, reflecting the success of past investments in biotech startups and dealmaking.

Summary: The U.S. Food and Drug Administration (FDA) has alerted health care providers about potential risks associated with the use of Quadrox Oxygenators and certain Venous Hardshell Cardiotomy Reservoirs manufactured by Getinge/Maquet. The company issued an Urgent Medical Device Removal notice due to concerns about compromised packaging sterility, posing a risk of infection/harm to patients.