Swedish neurotech startup Flow Neuroscience has secured FDA approval for the first brain stimulation device for home use in ...
The FDA is rolling out a pilot programme that could make it easier to bring digital health technologies (DHTs) for chronic diseases to market more quickly and easily. In line with its deregulatory ...
Dec 11 (Reuters) - The U.S. Food and Drug Administration has approved Flow Neuroscience's at-home brain stimulation device to treat depression, offering an alternative to typical antidepressants that ...
The FDA has approved its first at-home, nondrug therapy for depression, with a wearable brain stimulation headset developed by Flow Neuroscience. The agency issued a green light that covers the device ...
CTP Portal Next Generation also accepts Substantial Equivalence submissions. Step-by-step instructions on completing the forms; A more user-friendly interface that helps guide applicants through the ...
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Dr. Gottlieb: FDA is systemically trying to dismantle components of the vaccine approval process
Former FDA Commissioner Dr. Scott Gottlieb joins 'Squawk Box' to discuss concerns over the FDA's sweeping changes to how the U.S. handles vaccinations, impact on the public trust in vaccines, ...
The U.S. Food and Drug Administration plans to change how COVID vaccines and other shots are approved and administered. The memo, which was written by FDA chief medical and scientific officer Vinay ...
A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines. In an internal memo ...
A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that Covid-19 vaccination resulted in the deaths of 10 children. In an ...
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