SNOO Smart Sleeper Bassinet Wins FDA Clearance
The $1,700 infant sleeper is the first device to reach market indicated to help babies sleep on their backs. It was developed by Happiest Baby.
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By clearing Happiest Baby’s SNOO bassinet in March, the US FDA exercised authority over a product that typically would fall within the jurisdiction of consumer product safety regulators. One law firm questions what that might mean for manufacturers of similar products.
US researchers have found that home monitoring systems designed to pick up tell-tale signs associated with sudden infant death syndrome (SIDS), such as apnoea, may not be able to identify the majority of extreme cases.
NWW: Studies Back Nevro Pain Treatment, FTC Blesses Resonetics Nitinol Deal, Genetic Test Identifies Best RDN Patients
This week, studies supported Nevro’s spinal cord stimulation therapy and a VRx system that helps reduce pain; the American Medical Association found inconsistent insurance coverage of digital therapeutics; and Geneticure announced a cheek-swab test to identify which patients are most likely to benefit from renal denervation.