5440

14 ms·

1.
by 5440 3y ago
My son was just arrested for using this in his hacking club at high school. Be careful if you have kids with one. According to witnesses in the room, he was showing it to kids in his hacking club and they all thought it was just turning o
2.
by 5440 3y ago
I recommend you all read the 2023 FDA cybersecurity expectations before commenting. https://www.fda.gov/media/119933/download
3.
by 5440 3y ago
For those of you in FDA regulated devices, my clients started receiving FDA NSE letters for not performing fuzz testing. For example, "Though you have provided penetration testing, it does not appear that you have addressed the other
4.
by 5440 3y ago
Man this applies to me. I got an bioengineering degree and had to go to the US to find work. I started at $30K in the US and now I'm up to over $350K/yr. Would love to come back to Canada but the horrible expereince of applyin
5.
by 5440 3y ago
I'm a regulatory consultant and I am currently submitting at least 5-10 510ks/DeNovos per week to FDA for AI/ML devices for a variety of companies. I can't imagine the actual throughput from companies as I am just one p
6.
by 5440 4y ago
I'm currently working on a required CDC (Center for Disease Control) reporting function for a COVID test. For a second I thought this article was going to be extremely helpful.
7.
by 5440 4y ago
I audit a lot of these Fentanyl API (Active Pharma Ingredient) factories in China. Its noticeable to me when I go through the warehouses as to how much product is going to Mexico. Other segments go to India for legal fill finishing prior to
8.
by 5440 4y ago
I think those are generally good questions but the majority of submissions that FDA CDRH are reviewing are for imaging of ultrasound, MRI, XRAY etc, with a sprinkling of audio AI and maybe some individualized vaccines predictions at CDER. T
9.
by 5440 4y ago
That FDA review division does require that information and testing to be supplied with infusion pump testing. In fact, they are one of the few that routinely asks for substantial testing in repeated deficiency requests.
10.
by 5440 4y ago
The new draft literally doesn't change anything. It just defines some of the things that FDA has been already asking for in the past 7 years for every device submission. Just my opinion as someone who has worked on many infusion pumps
11.
by 5440 4y ago
Remember the square bonzai kitten thing. https://www.wired.com/2001/02/fbi-goes-after-bonsaikitten-co...
12.
by 5440 4y ago
I couldn't disagree with you more. I live in BC (and ONT), and all of us that migrated from the UK are much more pro-monarchy than most brits back in the homeland.
13.
by 5440 4y ago
Thanks for making me laugh. Very witty...
14.
by 5440 4y ago
I review software for at least 3-5 companies per week as part of FDA submission packages. The FDA requirements require traceability between reqs and the validation. While many small companies just use excel spreadsheets for traceability, t
15.
by 5440 5y ago
Before I entered management, I spent about 15 years as an engineer building "greenfield" drug manufacturing sites using automation packages such as Allen-Bradley, Emerson DeltaV and Siemens. There is nothing more time consuming t
16.
by 5440 5y ago
FDA approved the first BCI a few weeks ago from Neurolutions. Other companies like Synchron are going to beat Neuralink to market as well. https://newatlas.com/medical/first-fda-approved-brain-comput...
17.
by 5440 6y ago
I can give you a laundry list right now. For example, millions of vials are cracking around the rim, several of the filling rooms have mold issues, one of the vial hoppers is leaving metal particulates in the vials, weekly OOS for manufactu
18.
by 5440 6y ago
Regarding security, I think people would be really freaked out by the scope of attacks. One infusion pump I worked on this year was succesfully attacked over 200 times.
19.
by 5440 6y ago
I do a significant amount of breakthrough device fda/eu regulatory work in the BCI area. For those interested, its worth reading the FDA guidance: https://www.fda.gov/regulatory-information/search-fda-guidan... .
20.
by 5440 6y ago
I'm a regulatory consultant for AI software and submit several AI/ML FDA submissions per week. Overall, I've submitted 100+ AI/ML submissions to date. Generally, FDA has been really focused on locked algorithms even th
21.
by 5440 6y ago
Also https://www.eyenuk.com/us-en/products/eyeart/
22.
by 5440 6y ago
It works just fine. The samples are tested in the UV-VIS at 280nm.
23.
by 5440 6y ago
Please go to Fugetsu-do mochi, if you are ever in LA. They are 117 yrs/old and follow this Japanese tradition. They need business during COVID. https://www.fugetsu-do.com/
24.
by 5440 6y ago
I received one of these packages from singapore yesterday. There is no website on the packaging or inside of the envelope. Therefore, I don't understand the amazon review thing. Its just a package of seeds in a manila envelope.
25.
by 5440 6y ago
As part of a law firm, I've submitted about 50+ AI/ML applications to FDA and EU on behalf of our clients. I don't think Ive ever seen anything but U-Net and Resnet at this point. This article was helpful for me.
26.
by 5440 6y ago
As an FDA law firm engineer, I review and submit about three AI devices a week to FDA (Ive probably done at least 50 AI submissions at this point) As part of that I review the all the submission docs including the design specification for
27.
by 5440 6y ago
The most common model that we are putting in front of FDA several times per week for many companies is the AUROC model with minimum FDA requirements for specificity and sensitivity. I have some concern that the commentators on this article
28.
by 5440 7y ago
Here is what you are looking for. https://www.medrxiv.org/search/coronavirus
29.
by 5440 7y ago
That's very astute. I'm a Canadian living in the US and I ran away in 1996 during the terrible recession with the perception that life was better in the US.
30.
by 5440 7y ago
Exactly my point. The prosecutor told me its because the defense is trying to dispute everything and get the footage removed from evidence.

More ›