Intelligent Ultrasound seeks FDA clearance for new system

By staff writers

September 21, 2020 -- Ultrasound artificial intelligence software and simulation developer Intelligent Ultrasound Group has filed for regulatory clearance with the U.S. Food and Drug Administration (FDA) for its artificial intelligence (AI)-based peripheral nerve block (PNB) software.

The ScanNav AnatomyGuide PNB software will be able to automatically identify and highlight nerves, arteries, and other anatomical structures crucial for peripheral nerve block procedures, according to the company. The features show up on ultrasound scans in real-time.

Intelligent Ultrasound submitted a De Novo filing, a type of device request that can be marketed and used for future 510(k) submissions. It also submitted CE filings in July, with the hopes of earning revenues from the software by the second half of 2021.

The company expects to begin selling the classroom-based version of the software, ScanNav AnatomyGuide PNB Trainer, in the first quarter of 2021. Both the trainer and clinical software will be initially sold through existing sales channels in the U.K. and U.S.

Copyright © 2020

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