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…
I recommend you all read the 2023 FDA cybersecurity expectations before commenting. https://www.fda.gov/media/119933/download
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…
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…
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…
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.
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…
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.
Thanks for making me laugh. Very witty...
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…
Also https://www.eyenuk.com/us-en/products/eyeart/
The real authoritarians are about to take hold in washington for the next four years. Lets not kid ourselves. I was at a blm rally in dc freedom square this summer and some black ladies were screaming that they wont…
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…
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.
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…
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…
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.
Exactly my point. The prosecutor told me its because the defense is trying to dispute everything and get the footage removed from evidence.
My ring camera caught a murderer breaking a door down last year and it's been a headache for me ever since. Even though I didnt actually see the murder,I've been called to several depositions and had to take three…
"Win if you can, Lose if you must, but always cheat." Jesse Ventura via Werner Herzog.
I went to the OSHO meditation center in Pune, India for a few days, while working over there about a year ago. It changed my entire outlook on life, non-withstanding the Netflix documentary "Wild Wild Country" which is…
Is there a relationship between the timing of this post and the fact he was on the Joe Rogan show this week?
I regularly volunteer in a shelter. I have had a few of the attendees go a long paranoid rants about staying off the grid, big brother and so on...It seems like a large number of people that I've met want to be on the…
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…
I recommend you all read the 2023 FDA cybersecurity expectations before commenting. https://www.fda.gov/media/119933/download
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…
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…
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…
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.
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…
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.
Thanks for making me laugh. Very witty...
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…
Also https://www.eyenuk.com/us-en/products/eyeart/
The real authoritarians are about to take hold in washington for the next four years. Lets not kid ourselves. I was at a blm rally in dc freedom square this summer and some black ladies were screaming that they wont…
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…
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.
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…
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…
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.
Exactly my point. The prosecutor told me its because the defense is trying to dispute everything and get the footage removed from evidence.
My ring camera caught a murderer breaking a door down last year and it's been a headache for me ever since. Even though I didnt actually see the murder,I've been called to several depositions and had to take three…
"Win if you can, Lose if you must, but always cheat." Jesse Ventura via Werner Herzog.
I went to the OSHO meditation center in Pune, India for a few days, while working over there about a year ago. It changed my entire outlook on life, non-withstanding the Netflix documentary "Wild Wild Country" which is…
Is there a relationship between the timing of this post and the fact he was on the Joe Rogan show this week?
I regularly volunteer in a shelter. I have had a few of the attendees go a long paranoid rants about staying off the grid, big brother and so on...It seems like a large number of people that I've met want to be on the…