Nick Sleep of Intelligent Ultrasound explains the significance of FDA De Novo approval for their AI medical device
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Nick Sleep, CTO, of explains the significance of FDA De Novo approval for their AI medical device, ScanNav Anatomy PNB, meaning that there are no devices already on the market which meet the same clinical need.
Highlights
ScanNav Anatomy PNB uses the latest AI technology to assist qualified healthcare professionals to identify and label anatomy in live ultrasound images in preparation for ultrasound guided regional anaesthesia. The real-time anatomy highlighting supports healthcare professionals who perform ultrasound-guided procedures on a less frequent basis by making it easier for them to interpret the ultrasound view of the patient's anatomy.
By classifying ScanNav Anatomy Peripheral Nerve Block (PNB) under its de novo programme, the FDA has concluded that there are no devices already on the market which meet the same clinical need. It has therefore created the new generic type of device classification of real-time anatomy visualization and labelling device for ultrasound guided regional anaesthesia.
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