All i can say is that the Aortic Stenosis process was more less was on target once lodged.
It may be that the process for each type of clearance is different and hence has different time frames for their clinical studies/trials. My understanding of the process is that a group of cardiologists will interpret a set of images where the outcomes are already known and the AI algorithm scans the same images and the results are compared to benchmark effectiveness. The AI needs to be more accurate than human interpretation for utility of the algorithm to be proved.
There are also specialist consultants who advise the company on the process, time frames and interface with the FDA on behalf of the company. The time frames quoted by the company should be as per the advice they're receiving from the consultants.
At the end of the day it could take longer, that's our risk as shareholders. If you're not comfortable with the time-frames quoted it's up to you whether to stay invested or not.
good luck.
EIQ Price at posting:
25.0¢ Sentiment: Hold Disclosure: Held
A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.
(20min delay)