By Stephen Nakrosis

 

Shares of Profound Medical rose in post-market trading on Monday following the news that the U.S. Food and Drug Administration granted 510(k) clearance for the Thermal Boost module for use in conjunction with TULSA-PRO.

The stock rose 8.7% to $10.76 at 4:12 p.m. ET, and ended the day's regular session down less than 1% at $9.92.

TULSA-PRO can be used by surgeons to ablate prostate tissue in patients, including those with prostate cancer, the company said. The company said it is developing software modules that will work in conjunction with TULSA-PRO, covering a wide variety of prostate disease states, shapes and sizes.

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

September 25, 2023 16:46 ET (20:46 GMT)

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