RE: ScanNav clearance FDA26 Oct 2022 11:22
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.
The product is unique and is the second FDA clearance for IUG following the success of ScanNav assist which already has FDA clearance and is selling in the USA. I do not know how this company is at year low SP ... Revenue up to 5.8 million over a year. 5m in cash. Very low share issue and fantastic global AI medical training and realtime simulation products also selling around the world . MCAP is stupidly low and to me we should be closer to 50p not 10p