FDA Engagement

Report 29/10/20 ... Engagement with the FDA is progressing, led by Ruth Cremin, as we plan out our regulatory strategy and pivotal clinical trial, designed to support first regulatory submissions

In research of EMV's technology, imo, this has the potential to seek a submission pathway called "US Food & Drug Administration" "Breakthrough Devices Program"

https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program#s3




In short... "EMvision's technology can/will change medical practice"

Example..... Current method of stroke imaging via the gold standard machines are CT & MRI. The challenge is getting the patient to these machines in a timely manner i.e in the first hour of stroke onset. There are an insane amount of people in the world who don't have the luxury of living near a highly equipped hospital who have these imaging devices

Medical practice change..... EMvision developing a device that brings rapid stroke diagnosis to the patient!

EMvision's Pilot Clinical Trial comments...."It was observed that the EMVision device was able to classify stroke type (haemorrhagic or ischaemic) with an overall accuracy of between 93.3% and 96%"



Co-chairs of the Australian Stroke Alliance and past presidents of the World Stroke Organisation, Professors Stephen Davis AM and Geoffrey Donnan AO provided expert feedback......

“it cannot be underestimated how important this cutting-edge technology could become for future pre-hospital stroke management.”



Not intended as financial advice, this is just my views on how far this ASX BEAST could go!
DYOR