This article describes and compares the requirements for market entry of medical device software in the EU and US, based on the different applications and intended use that software can have in healthcare.
Mice help identify target for chronic pain relief: Research with mice identified mu opioid receptors in the brain’s locus coeruleus as a key brake on chronic neuropathic pain. Removing the receptors increased sensitivity to touch and heat after nerve injury, while restoring them reversed the hypersensitivity, pointing to a potential target for pain relief with fewer risks than traditional opioids.
Fecal transplants can increase tolerance to peanuts sixfold in people with food allergies, new research out of Boston Children’s Hospital has suggested.
Amgen, LeBron James, and the world’s top-subscribed YouTuber MrBeast may sound like a Mad Lib of unrelated influences; however, the unlikely trio has one thing in common: a drive to fight childhood cancer.
Researchers learn more about mechanisms of preeclampsia: Severe preeclampsia appears to be more than a placental disease, involving changes in maternal tissues and immune cells, according to a study in Science Advances. Researchers used single-cell RNA sequencing and spatial transcriptomics to map nearly 293,000 cells across the fetal-maternal interface, identifying 27 distinct cell populations and how they communicated with one another, says researcher Sara Hillman. “What surprised us were several pathways that emerged in severe preeclampsia, particularly leptin signaling and mitochondrial dysfunction across the fetal-maternal interface,” Hillman said.
Mouse research points to autism targets: Rapamycin temporarily reversed autism-like brain changes and improved behavioral symptoms of adult mice exposed to maternal inflammation, researchers reported in Nature Communications. The drug improved brain signaling within hours, although the effects were short-lived, pointing to potential new therapeutic targets for autism.
The US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has finalized a trio of guidance documents to promote greater participation and diversity in oncology clinical trials. The documents address three areas: a patient’s performance status, laboratory values, and washout periods.
A brain-computer interface that bypasses a spinal cord injury allowed a man with paralysis to move his arms and hands, regain some sense of touch, and perform tasks such as feeding himself after months of training. Some improvements persisted even when the device was turned off, suggesting the therapy may promote lasting nervous system recovery.
Patient advocates urge caution on reducing animal research: A patient advocacy group is urging regulators to validate alternative research methods alongside animal models rather than replacing them prematurely, arguing that current non-animal approaches cannot yet replicate the complexity of whole-body responses. The group warned that moving away from animal research too quickly could leave important safety gaps for vulnerable populations, including pregnant women, children, and people with rare diseases.