Intelligent Ultrasound (AIM: MED ) has submitted its De Novo filing to the US FDA for its ScanNav AnatomyGuide Peripheral Nerve Block (PNB), an AI-based ultrasound product that can identify and highlight anatomical structures in real-time on a live ultrasound image.
The FD filing follows the CE marking regulatory submission in July this year, and subject to CE and FDA approval, the Company is aiming for initial revenues from ScanNav in the second half of 2021.
The product is being developed for use during Peripheral Nerve Block (“PNB”) procedures to support less experienced practitioners in this technique. PNB is a form of local anaesthetic that can be used in certain surgical procedures as an alternative to general anaesthesia.
ScanNav AnatomyGuide Peripheral Nerve Block Trainer, a classroom-based version of the product that does not require regulatory approval and aims to provide pre-clinical teaching to clinicians, is expected to be available for sale to hospital training departments during Q1 of 2021.
Both products will initially be sold through the group’s existing direct sales channels in the UK and North American markets.
The ScanNav software highlights structures such as nerves and arteries on a live ultrasound scan image that are important to be identified during PNB needling procedures and can provide trainees a safe environment to train.
The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.
“AnatomyGuide will help tip the balance of safety and confidence in favour of performing regional anaesthesia. Our aim is to make a real clinical difference to patients by increasing the availability of regional anaesthesia through cutting edge technology” said Dr David Burckett-St.Laurent, Consultant Anaesthetist at the Aneurin Bevan University Health Board.
Shares in Intelligent Ultrasound have climbed over the past three months and closed Thursday afternoon trading at 14.25p.
The aesthetic is injected near a specific nerve or bundle of nerves to block sensations of pain from a specific area of the body.
“This is an important milestone in the process of bringing our ScanNav AnatomyGuide AI software to market,” said Nicholas Sleep, Chief Technology Officer of Intelligent Ultrasound.
He added, “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."
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