Tag: FDA
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Standard Electronic Biomarkers Validated for Schizophrenia
A new study validates standard electronic instrument measures of healthy individuals and people with schizophrenia to enable reliable clinical trials for treating the disease.
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RSV Vaccine Breakthrough Examined at AAAS Meeting
As three vaccines against respiratory syncytial virus reach FDA review, a scientific conference explored a key breakthrough researchers achieved to get to this point.
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Panel: A.I. Regulation Needed, But Long Way Off
A panel of data scientists at a professional meeting says artificial intelligence needs more rigorous oversight, but many questions remain on who and how to do the regulating.
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Environmental Biomarker Start-Up Gains $16M in Early Funds
A new company developing diagnostics for neurological and other disorders based on environmental exposures is raising $16 million in venture funds.
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Audio Digital Biomarkers Start-Up Raises $3.7M in Seed Funds
A new company developing techniques to analyze internal physiological sounds captured by stethoscopes as health indicators is raising $3.7 million in seed funds.
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Over-the-Counter Naloxone Receiving Faster FDA Review
The opioid overdose drug naloxone in nasal spray form is receiving priority review from the Food and Drug Administration as an over-the-counter drug.
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FDA Clears AI Heart Failure Detection System
The Food and Drug Administration authorized for marketing an algorithm-driven medical device for diagnosing a common, but difficult to detect, type of heart failure.
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Trial Shows Fast-Absorbing Opioid Overdose Nasal Swab
Results of a clinical trial show a nasal swab dispensing an opioid antidote transfers more of the antidote into the blood stream than syringe injections or nasal sprays.
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RSV Nose Drops Vaccine Gets FDA Fast Track Tag
A vaccine designed from engineered live viruses and taken as nose drops to prevent respiratory syncytial virus received a Food and Drug Administration fast-track designation.
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Grant Funds Regenerative Gel for Treating Skin Ulcers
A California state research agency is funding preclinical development of a gel designed to regenerate stem cells in the skin to help heal venous skin ulcers.