Less than a week after announcing 3 new guidance documents to streamline the review of digital health, the FDA is moving to refine its 510(k) medical device approval pathway.
Three-dimensional neural circuit "asteroid" composed of neurons (blue) and astrocytes (red and green) generated from human pluripotent stem cells.
For the first time ever, a mobile video game used to assess and treat a disease is headed for an FDA review.
Infant deaths from critical congenital heart disease (CCHD) declined by 33.4 percent in eight states that mandated pulse oximetry screening for newborns, according to a study published online Dec. 5 in JAMA.
Researchers compare the volumes of various regions of the brain in people with and without schizophrenia to identify the key brain structures involved.
Blocking the motion of a key protein frees oxygen to injury iron-dependent proteins in lung and breast cancer cells, slowing their enlargement and making them more straightforward to kill.
Maternal stress during the second trimester of pregnancy may influence the nervous system of the developing child, both before and after birth, and may have subtle effects on temperament, resulting in less smiling and engagement, as well as diminished ability to regulate emotions.
More connected medical devices are coming online every day, reshaping the way that healthcare networks are designed, used and secured.
A man may soon be forever free of the previously incurable disease he was born with 44 years ago. On Monday, in a medical first, Brian Madeux received an experimental in-body gene-editing treatment intended to cure him of Mucopolysaccharidoses II, known as MPS II or Hunter syndrome, a rare disorder that causes progressive damage to the body's cells.
Obesity is often attributed to a simple equation: People are eating too much and exercising too little. But evidence is growing that at least some of the weight gain that plagues modern humans is predetermined.
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