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.
The European Commission has published two delegated acts that expand the list of well-established technologies (WET) under the Medical Devices Regulation (MDR) that are exempt from conducting clinical investigations and technical assessments. The first regulation applies to implantable devices and Class III devices, while the second regulation focuses on Class IIb implantable devices.
Metairie man functionally cured of sickle cell disease through gene therapy: A Metairie man is now the first person in Louisiana to be functionally cured of sickle cell disease through gene therapy. Daniel Cressy, 23, of Metairie, La., has become the first person in the state to be functionally cured of sickle cell disease through gene therapy at Manning Family Children’s Hospital. After two years of treatment, Cressy is pursuing his goal of becoming a commercial pilot. “All the support from the state and supporting governing bodies, I think everyone can soon obtain this treatment … keep going, there is hope for a cure,” Cressy says.
Actress Halle Berry invests in startup updating a century-old tool for modern women: Actress and women’s health advocate Halle Berry is investing in a startup called Nella, founded by Fahti Khosrowshahi, to modernize the speculum, which is largely the same tool now as it was a century ago. Nella’s speculum is smaller and less uncomfortable, which may reduce the anxiety and discomfort that lead 72% of women to delay annual pelvic exams. “When I found out that a woman designed this for women, I started to feel instantly that we do have power. We can change our future,” Berry said.
The FDA has sent an End of Enforcement notice to consumer wearable device company Whoop, putting a formal end to the Agency’s investigation into its blood pressure tech use.
Adhering to Quality by Design (QbD) principles and employing risk-based monitoring strategies should reduce the likelihood of Clinical Investigators or Sponsors receiving a Form FDA-483, Inspectional Observations, following a Bioresearch Monitoring (BIMO) inspection.
Mice with DMD (Duchenne Muscular Dystrophy) regain muscle function after targeted mRNA treatment: Engineered extracellular vesicles delivered full-length dystrophin mRNA to skeletal muscle of mice with Duchenne Muscular Dystrophy (DMD), restoring dystrophin production and improving muscle strength and function, according to a study in Nature Biomedical Engineering. Safety testing with non-human primates found the treatment was well tolerated, supporting its potential as a non-viral alternative to current gene therapies.
The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an integrated CGM (iCGM) indicated for people two (2) years of age and older who do not use insulin. The FDA previously cleared the Stelo Glucose Biosensor System OTC for individuals 18 years and older in March 2024.
Twenty-six years of chasing New York City sex crimes as the face of “Law & Order: Special Victims Unit (SVU)” has prepared award-winning actress Mariska Hargitay to put on her own detective hat in her next role: “Investigating Myeloma” with Bristol Myers Squibb.