It is true that many imaging devices currently in use have limitations in detecting bleeds below a certain size, often around 2mm. The benchmark expectation for bleed detection is commonly set at 5mm.
The decline in EMV's stock price is likely not reflective of its underlying fundamentals.
Based on the provided chart, it is evident that the speculative/emerging sector of the market, particularly pre-revenue tech companies, has been facing challenges for some time now.
Considering the current macro market environment, it appears that EMV has demonstrated better resilience compared to other comparable stocks.
When it comes to the quality of the images, it is reasonable to assume that EMV directors would not endorse or make claims about "image quality improvement" without conducting trials in a clinical setting. Similar to their previous approach, they refrained from making claims until the appropriate time, suggesting that this situation is likely the same. Furthermore, if they expected the image quality to be the same or worse, it is unlikely they would invest considerable time and resources into ongoing multi-site trials.
It is also important to note that it may not be permissible for a drug company or medical device manufacturer to make claims about their product's performance before completing clinical trials. Therefore, it is reasonable to assume that similar rules apply to medical devices in terms of making public claims before validating them in a clinical setting.
Again, considering EMV's conservative approach, where they prefer to under promise and over deliver, it is doubtful that they would invest significant time and money into a multi-site trial if they believed the image quality had not improved or had regressed.
Furthermore, it is essential to remember that image quality is not the sole determining factor; the device's safety, usability, and its ability to provide utility in a clinical setting for decision making are equally important. If a device offers high-definition images but fails to detect crucial elements such as a clot, the images might appear impressive, but the device would ultimately be useless.
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