Nobody knows anything about Auricle. We don't know if they're contract manufacturing or doing it in-house. We don't know what supply agreements they already have. We don't know what funding they have.
I agree things are moving slowly. But the speculation about the company employees, or Dr. Shore's relocation mean nothing in terms of project delay. If anything, her relocation to UC Irvine indicates the move into the next phase of the process, which would naturally minimize her direct role. I seriously doubt what's been her life's work is no longer a priority for her.
I think that once a medical device is submitted to the FDA for approval, any updates to the code is a change and is required to be resubmitted.
From my understanding, the software is an external tool used to tune the device. It technically has nothing to do with the device itself and probably won't have much impact on the FDA approval. Despite how messy the code looks, we can assume it does what it's supposed to since the trial was successful.
That would not scale. Re-submission is required when "Changes made with intent to significantly affect safety or effectiveness of a device".
True, I don't. But I have some idea about starting a company, what it takes, and how it looks like, and the idea is from an experience in tech industry that did not require any government approvals or even manufacturing.
Jon Pearson has claimed in an email that Auricle is fully funded at this point.
Not all updates to the code of medical devices require a new FDA submission. The need for re-submission depends on the nature of the update and its impact on device safety and effectiveness. The FDA provides guidelines to help manufacturers determine if a software change necessitates a new submission:
Depends on severity.
That would be ideal! It's been far too long without an update, leading to much speculation and pre-mature disappointment. @Hazel, if you could please reach out to Dr. Shore for another update, that would be outstanding!
Why would they have a product ready to go in a year? They don't even have FDA approval yet, and it's likely to take up to a year just to obtain that. In the interim they would have to build a massive amount of biz relationships before even conceiving of manufacturing. I get people wanting it to happen as soon as possible, but acting like the device is a failure even if their original schedule for FDA approval gets delayed is just setting yourself up for failure and is honestly probably a sign that some are a bit too invested in this product than warranted.
If they're submitting as a 510(k), the FDA tries to have a decision in 90 days, give or take. That can be affected by staffing levels, and if the FDA has questions called "AI requests" or additional info requests back to the submitter. That can add time and is not a sign of anything wrong; it's an accepted part of the process. Then it could be a little longer but it shouldn't be much more than a few months total time. It's very likely that they'll submit as a 510(k). I've already explained this a few times in this thread!
And per Gene Parunak from in2being.com, who is very likely (speculation) handling their submission, recent actual approval times for 510(k) is ~140 days.
This is their stance, from Jon Pearson, CEO of Auricle:
Basically, I would not hold my breath. They are working on it, they are doing their best (I sincerely believe so based on my interactions with Jon and Susan), but this can take some time still. We just need to be patient and understanding.
This is still at its core an assumption though. Realistically no one knows what they are doing, how they're submitting, nor what hiccups or delays in the process on their end or the FDA's might occur.
I would be surprised at that, to be honest. It is one thing saying it, but money talks. And the copycat devices will start to pop up soon.
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