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. . . . → Read More: Lung Model Developed to Test E-Cigarettes, Hookah
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 Comments are closed  New products, Regulations  biomedical, engineering, FDA, grant, health care, life sciences, materials science, medical device, physical sciences, university 
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. . . . → Read More: FDA Expands Evidence Project to Replace Trials Comments are closed Joint ventures/collaborations, Regulations biomedical, clinical trials, FDA, life sciences, software, university 
The Food and Drug Administration approved a daily pill with 2 drugs to lower viral loads in people with HIV, but who have not yet taken other HIV drugs. . . . → Read More: FDA Approves Single Dual-Drug Pill for HIV Comments are closed Regulations biomedical, clinical trials, FDA, HIV, life sciences, pharmaceuticals, U.K. 
A device sending weak electric impulses into the brain from headphones is authorized by the Food and Drug Administration to treat depression, anxiety, and insomnia. . . . → Read More: Brain Stimulator Device Cleared for Depression, Insomnia One comment - (Comments are closed) Regulations biomedical, clinical trials, engineering, FDA, life sciences, medical device, physical sciences, physics, software 
An assessment of a closed-loop insulin pump system shows a sizeable proportion of first-time users stopped using its automated feature because of problems in making it work. . . . → Read More: Insulin Pump Shown Difficult for Many Users Comments are closed Regulations biomedical, engineering, FDA, life sciences, medical device, software 
The commissioner of the Food and Drug Administration warned that the sharp rise in teen electronic cigarette use is an epidemic threatening the public health. . . . → Read More: FDA Chief Calls Teen Vaping an “Epidemic” Comments are closed Regulations agriculture, biomedical, biotechnology, FDA, health care, medical device, pharmaceuticals, special 
A mesh envelope infused with antibiotics holding an implanted cardiac device is shown in a large-scale clinical trial to reduce the number of infections associated with those devices. . . . → Read More: Antibacterial Sleeve Protects Against Implant Infections Comments are closed New products biomedical, clinical trials, FDA, heart disease, life sciences, medical device, pharmaceuticals 
During his tenure, FDA issued a number of guidance documents outlining regulatory processes and practices that streamline reviews, yet are still dictated by scientific evidence. . . . → Read More: Commentary – Scott Gottlieb’s Legacy One comment - (Comments are closed) Regulations biomedical, biotechnology, clinical trials, FDA, genomics, health care, life sciences, medical device, pharmaceuticals, software 
Clinical trials testing the genome editing technique Crispr for sickle cell disease and beta thalassemia, two inherited blood disorders, enrolled and infused their first patients. . . . → Read More: Trials Underway Testing Crispr for Blood Disorders Comments are closed Joint ventures/collaborations, New products biomedical, biotechnology, Canada, clinical trials, Europe, FDA, genomics, life sciences, pharmaceuticals, stem cells, U.K. 
Food and Drug Administration is releasing for comment regulatory guidance for its review of implanted medical devices that connect human brains to computer systems. . . . → Read More: FDA Drafts Brain-Computer Device Regulatory Guidance One comment - (Comments are closed) Regulations biomedical, clinical trials, computer science, engineering, FDA, life sciences, medical device, physical sciences, preclinical, semiconductors, software |
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