Media Thread, page-2111

While it is a little disappointing that we will need to wait a little longer, the business still rolls on. You'd think by the market reaction the FDA said no! Everyone has their owns reasons for investing, it's a shame that we couldn't see a bounce back to 4.5c plus, the sellers would be scrambling to get their shares back. But they played it well. But getting FDA is not just submit and get it. Its a novel device so of course the will have lots of questions, and privacy will be huge for them also in the USA. They likely are outsourcing to someone in regards to their actual security protocols.

The FDA’s repeated requests for PainChek to answer questions before approval likely stem from the agency’s rigorous evaluation process for medical devices, ensuring safety, effectiveness, and compliance with regulatory standards. Additional compliance with Quality System regulations or post-market surveillance plans could prompt further questions. Multiple rounds of questions could reflect iterative feedback to confirm the tool’s consistency and generalizability, especially since AI-driven devices often face scrutiny for potential biases or limitations. The FDA closely reviews labeling, including instructions for use and claims about the device’s capabilities. If PainChek’s proposed use was unclear or overstated the device’s benefits, the FDA might have requested revisions to ensure accurate representation if not fully addressed initially. The FDA’s review often involves back-and-forth communication to refine the submission. If PainChek’s responses raised new questions or didn’t fully resolve concerns, further inquiries would follow. This iterative process is common for complex or novel devices and can involve mid-cycle meetings or advisory committee input.

Without specific details about PainChek’s submission or the FDA’s exact requests, it’s hard to pinpoint the precise reasons. However, the FDA’s thoroughness suggests they are ensuring PainChek meets stringent standards for clinical reliability and regulatory compliance. Once we get that, then as we have discussed, new markets and it also paves the way for use in other setting, disability, hospitals etc.