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)

Copyright (c) 2023 Dow Jones & Company, Inc.
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