We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...
The U.S. Food and Drug Administration told staff this week it cannot guarantee work space or parking spots among the hurdles ...
In Thursday's meeting, the director of the FDA's Center for Drug Evaluation and Research said plans for coming layoffs were ...
Lifeward announced today that it received FDA 510(k) clearance for its latest-generation personal exoskeleton device, ReWalk ...
Class II recalls — a grade below the most serious Class I recalls — reference a situation in which the use of or exposure to ...
Most medical devices in the United States come to market with limited clinical data, and device surveillance is viewed as a ...
Jay Bhattacharya, nominee for National Institutes of Health director, and FDA pick Marty Makary clear key Senate committee.
FDA clearance for the newest generation of its personal exoskeleton device, the ReWalk 7. The seventh generation of the ReWalk, a wearable exoskeleton that allows individuals with spinal cord injury ...
Medical Device Network on MSN1d
Nearly a third of FDA medical device adverse event reports filed lateA new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
Nearly 10% of postmarket device safety reports in MAUDE were submitted over 6 months after the safety event occurred.
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
Molecular Devices' CellXpress AI streamlines cell culture processes, reducing human error and improving efficiency in drug ...
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