RadNet Gets FDA Clearance for Quantib Prostate 3.0 Software
01 May 2023 - 9:15PM
Dow Jones News
By Stephen Nakrosis
RadNet Inc. on Monday said its Quantib B.V. subsidiary received
510(k) clearance from the Food and Drug Administration for the
third-generation release of its Quantib Prostate MRI artificial
intelligence software.
RadNet said the software offers a suite of tools to improve
reporting quality and speed, including AI-based segmentations,
one-click segmentation of lesion candidates, and standardized
reporting. The upcoming will include an improved prostate and
sub-region segmentation algorithm, among other functionalities, the
company said.
Section 510(k) of the Food, Drug and Cosmetic Act requires
manufacturers to give the FDA 90 days advance notice before they
can market a medical device.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
May 01, 2023 07:00 ET (11:00 GMT)
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