Pre-Market

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Pre-Market

Describing trading that occurs on a security before an exchange opens for the day. Pre-market trading is often less liquid than regular trading because participation by market makers is voluntary, whereas market makers are required to serve as a counterparty for a security during trading hours. However, pre-market trading can give some indication on the likely direction of the security's price movement over the course of the trading day. See also: After-hours trading.
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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 review.
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.