Intelligent Ultrasound submits FDA filing for AI software

Artificial intelligence-based ultrasound software and simulation company Intelligent Ultrasound has submitted its De Novo filing to the US Food and Drug Administration (FDA), it announced on Friday, for its ‘ScanNav AnatomyGuide Peripheral Nerve Block’ (PNB) artificial intelligence-based software.

The AIM-traded firm said that, following the CE regulatory submission in July, and subject to CE and FDA approval, it was aiming for initial revenues in the second half of 2021.

It said the ScanNav AnatomyGuide PNB AI software would, automatically and in real-time, identify and highlight structures such as nerves and arteries on the live ultrasound scan image that are important to be identified during PNB needling procedures.

ScanNav AnatomyGuide PNB Trainer, a classroom-based version of the product that does not require regulatory approval and would provide preclinical teaching to clinicians, was expected to be available for sale to hospital training departments during the first quarter of 2021.

Both products would initially be sold through the group's existing direct sales channels in the UK and North American markets, the board said.

“This is an important milestone in the process of bringing our ScanNav AnatomyGuide AI software to market,” said chief technology officer Nicholas Sleep.

“Although we continue to discuss with manufacturers the option of integrating our software into their future ultrasound machines, the FDA and CE submissions are a key step in enabling us to bring our own ultrasound AI products to market in 2021.”

At 0906 BST, shares in Intelligent Ultrasound were down 4.11% at 13.66p.