By Michael Susin

Intelligent Ultrasound Group PLC said Thursday that the U.S. Food and Drug Administration has granted a de novo clearance for clinical use of its AI medical device, ScanNav Anatomy Peripheral Nerve Block.

The company, which uses artificial intelligence in health applications, said that the ScanNav Anatomy PNB product can now be launched into the U.S. anesthesiology ultrasound market.

The company said it seeks to launch the system to the U.S. market shortly, through its existing in-house sales resources.

The clearance follows the FDA's conclusion that there are no devices already on the market that meet the same clinical need, it added.

Intelligent Ultrasound said that the technology supports healthcare professionals by making it easier for them to interpret the ultrasound view of a patient's anatomy.

The company also added that it continues to seek to license an integrated version of the product to major ultrasound manufacturers.

Write to Michael Susin at michael.susin@wsj.com

(END) Dow Jones Newswires

October 20, 2022 04:33 ET (08:33 GMT)

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