Carestream gets FDA nod for ultrasound systems

Carestream Health has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Touch Prime and Touch Prime XE premium ultrasound scanners.

Touch Prime and Touch Prime XE are the first two products in Carestream's new ultrasound family and are suited for general diagnostic imaging use in radiology, according to the vendor. Touch Prime XE -- Carestream's top-of-the-line system -- utilizes the company's Touch Prime SynTek architecture, which is designed to offer enhanced spatial detail with higher frame rates to better visualize moving structures while optimizing image formation to decrease noise and artifacts, Carestream said.

Touch Prime XE also features imaging and Doppler improvements aimed at consistently visualizing subtle tissue contrast differences and enhancing the ability to see small structures, the company said. The scanner can also produce frame rates higher than 100 Hz; optional features include DICOM, wireless connectivity, barcode and badge readers, and elastography.

Touch Prime and Touch Prime XE both feature sealed, touch-control panels; 18-second cold boot times; Smart Connect transducer technology for one-touch selection of desired transducers; the ability to swipe badges to log in to the system; and easy cart adjustments, according to the vendor. Both systems can now be ordered in the U.S., with shipments expected to begin in the fourth quarter.

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