Tag: FDA
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FDA Clears Wearable App Device for Migraine
The Food and Drug Administration authorized a wearable nerve-stimulation device controlled by a mobile app to treat acute migraine headaches.
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FDA Approves Rare Infant Disease Gene Therapy
The Food and Drug Administration today approved a treatment for spinal muscular atrophy in young children that replaces a faulty gene in motor neurons with a healthy one.
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Trial Shows Surgical Pain Managed Without Opioids
Results from a clinical trial show patients recovered from their hernia surgeries with non-opioid pain medications, and stayed off opioids for 15 days.
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FDA Issues Final Biosimilar Guidance
The Food and Drug Administration issued its final guidance on regulating the interchangeability of so-called biosimilars with original biologic drugs.
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Trial Testing Heart Device Outcomes by Gender
A clinical trial is underway tracking patients with implanted heart devices for 3 years to find any differences in health outcomes between men and women.
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Kidney Diagnostics Receive FDA Breakthrough Tag
An algorithm-driven diagnostic test for chronic kidney disease is receiving a breakthrough device designation from the Food and Drug Administration.
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FDA Approves Transplant Lung Preservation System
The Food and Drug Administration approved a medical device that restores and maintains lungs for transplants that may not otherwise be acceptable.
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Gel Boosts T-Cells for Cancer Treatments
A biomedical engineering team devised techniques using a gel to produce more engineered T-cells, which in lab mice stopped the growth of tumors.
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Lung Model Developed to Test E-Cigarettes, Hookah
A three-dimensional model of a human lung is being developed to test health effects of new trends in smoking, such as electronic cigarettes and hookahs.
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FDA Expands Evidence Project to Replace Trials
The Food and Drug Administration is expanding a demonstration project with a Boston teaching hospital that tests the value of real world evidence to replace some clinical trials.