Healthcare company GE Healthcare reported on Friday the receipt of premarket
clearance from the US Food and Drug Administration for the first 2D digital mammography system, called Senographe Pristina with Self-Compression, that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken.
To better support FDA's lifesaving mission while carefully spending taxpayer dollars, the President's Budget asks companies that benefit directly from FDA's premarket
review of medical products to finance 100 percent of FDA's premarket
For products that are already on the market, manufacturers have 30 months to comply with the premarket
approval application requirements.
Under this regulation, surgical gowns and masks were classified as Class II medical devices and, as such, made subject to premarket
review under section 510(k) of the Federal Food, Drug, and Cosmetic Act.
Class II devices may have special controls, such as performance standards, special labelling requirements, and/or premarket
data requirements in addition to general controls.
6% in premarket
trading after the world's largest home improvement chain raised its yearly outlook after posting a profit beat.
5 percent in premarket
trading after the chip maker's revenue outlook missed expectations on Wednesday, pointing to a slowing PC industry and slower production of tablets using its chips.
Bunny bankers Premarket
Olly 5pts win at 6-4 Betfred, Newcastle 4.
We are investing resources so that new device reviewers at CDRH are equipped to handle the range of issues that arise during premarket
device reviews," said Jeffrey Shuren, M.
Companies will be required to pay $4,049 per 510(k) premarket
submission, compared with the $4,348 they paid this year.
financials opened with strong gains Tuesday, boosted by solid earnings results and positive housing data released premarket
Unless exempt by regulation, new devices must clear FDA premarket
review via either the 510(k) premarket
notification process, which determines if a new device is substantially equivalent to another legally marketed device, or the more stringent premarket
approval (PMA) process, which requires the manufacturer to supply evidence providing reasonable assurance that the device is safe and effective.