Complying with FDA Standards
9:18
Do FDA Standards Change Over Time?
16:36
Пікірлер
@Slapdatknee
@Slapdatknee Ай бұрын
Does it effect the body negatively?!!! My loved one has MS and he just got diagnosed. some people say that biological treatments increase the risk of catching a brain virus that kills patients Is this true?!?!!!!
@BookgirlReadsAllday
@BookgirlReadsAllday 2 ай бұрын
Diane M Welsh is the snake who let Philips off the hook with Zero Apology and horrible excuse for settlement. If you get Diane M welsh to sell her soul again your company too can commit mass murder and increase your revenue simultaneously!
@rhondaadams1546
@rhondaadams1546 3 ай бұрын
Looking forward to the grassroots innovation and partnership PPP with MEDHealth!!!
@Nunawading
@Nunawading 4 ай бұрын
Nonsense
@matthewmorgan6814
@matthewmorgan6814 5 ай бұрын
Wouldn't you want a clinical AI to have good discrimination?
@sbutler888
@sbutler888 8 ай бұрын
Interesting and informative content. Thanks Gene and team! Keep up the great work!
@adanjsuarez
@adanjsuarez 8 ай бұрын
Thanks for your video. I am starting to be involved in all of those process as software engineer, and you gave me the basics that I needed.
@medtechcrossroads
@medtechcrossroads Жыл бұрын
Thousands of children each year undergo life saving surgeries that require anesthesia. However, the FDA states that, while anesthesia has been tested on adults, not much study has actually been done on the effects of anesthesia in children. Furthermore, in young animals, anesthesia has been shown to have severe negative side effects, including brain damage. So, FDA has collaborated with the International Anesthesia Research Society to create SmartTots, a Public Private Partnership, to coordinate and fund anesthesia research with the goal of making healthcare even safer for adults and children alike. Watch the full video or visit smarttots.org for more information.
@medtechcrossroads
@medtechcrossroads Жыл бұрын
Thousands of children each year undergo life saving surgeries that require anesthesia. However, the FDA states that, while anesthesia has been tested on adults, not much study has actually been done on the effects of anesthesia in children. Furthermore, in young animals, anesthesia has been shown to have severe negative side effects, including brain damage. So, FDA has collaborated with the International Anesthesia Research Society to create SmartTots, a Public Private Partnership, to coordinate and fund anesthesia research with the goal of making healthcare even safer for adults and children alike. Watch the full video or visit smarttots.org for more information.
@gogecka9717
@gogecka9717 Жыл бұрын
Conservatives when they find out every drug has some level of side effects in which we have balanced out the positives to the negatives: 😱😱😱😱😱
@dawlben2247
@dawlben2247 Жыл бұрын
How many of those are dental procedures?
@HaHaHannah1369
@HaHaHannah1369 Жыл бұрын
That’s why a risk benefit analysis is done. It’s why a gall bladder surgery for a 16 year old may be called elective but open heart surgery on an infant is an emergency. It also depends on how long they’re under. What do you propose? We stop performing life saving surgeries on young people? Let them die?
@anahigalindo405
@anahigalindo405 Жыл бұрын
wtf
@charlidabomb3723
@charlidabomb3723 Жыл бұрын
It's not like we are putting them under because we want to. Along with all the other risks, it's a measure of benefit vs risk. Duh. We don't exactly have a huge arsenal of other more acceptable options, so what exactly is the point here? Either show us the solution to the issue or stop crying about the risk, I hate when people just perpetuate negativity without a positive solution. Jeez.😒
@Bear38-u7l
@Bear38-u7l Жыл бұрын
Yes the Question like how does it affect animals in general? What animals are they testing it on do they have a similar weight to humans? How does their body expel the chemical compared to ours? What source did you get this from? What was the purpose of the study? Is it a negligible risk? Who is this guy?
@ShinySquirtle93
@ShinySquirtle93 Жыл бұрын
1. Source? 2. If your child needs open heart surgery, are you gonna let them be awake for that shit?
@ruthlewis6678
@ruthlewis6678 Жыл бұрын
What is your point? Any chance some of these surgeries may have saved lives? And for little ones, if they are not knocked out, they won't hold still long enough for the procedure. Speaking from personal experience. You want to scar them for life - tie them down and pump them full of pain killers.
@rhettadams9001
@rhettadams9001 Жыл бұрын
Solution: Ban Children
@am_i_hyper
@am_i_hyper Жыл бұрын
Soo? What’s the point of this video…
@Registole
@Registole Жыл бұрын
So?
@24thMandark
@24thMandark Жыл бұрын
Aaaaannnnnd? 🤨
@Puertoricanmarriedtofilipina
@Puertoricanmarriedtofilipina Жыл бұрын
They made so much money selling it to the military over the years and they can only pay out 6 billion dollars 🤔
@elijahwebster4325
@elijahwebster4325 Жыл бұрын
wtf is this
@majikman1239
@majikman1239 Жыл бұрын
That’s what I’m sayin
@tonyeisenhut259
@tonyeisenhut259 Жыл бұрын
Gene - thank you for the chance to be on your podcast! Really enjoyed getting a chance to share with you.
@GCAVIDEO
@GCAVIDEO Жыл бұрын
Excellent presentation - thanks!
@jakefromstatefarm6285
@jakefromstatefarm6285 Жыл бұрын
A well deserved 9.5k views
@LJSheffRBLX
@LJSheffRBLX Жыл бұрын
Your content is captivating. Let's collab and weave more stories!
@paolodimartino241
@paolodimartino241 Жыл бұрын
*PromoSM*
@tommiethornton7636
@tommiethornton7636 2 жыл бұрын
『p』『r』『o』『m』『o』『s』『m』 🏃
@Melinna48
@Melinna48 2 жыл бұрын
Are there legal limitations on marketing an FDA cleared device? For example, if the device is approved for treating specific diagnoses, what happens if the device is used for treating more diagnoses?
@medtechcrossroads
@medtechcrossroads 2 жыл бұрын
Melinna, good questions. Feel free to reach out through our website contact form at in2being.com for more information, but in short, the intended use of the device and the indications for use as cleared by FDA determine what how the device can be legally marketed. While doctors and patients may decide to use a device "off-label", the marketing company's statements are limited to what claims the device is actually cleared for.
@williamhui6195
@williamhui6195 3 жыл бұрын
We found our N95 respirator can be registered as FDA product code MSH in FDA database with no 510(k) is needed. Once we got the establishment number issued by FDA, we can only use FDA registered for our N95 respirator. However, why we cannot declare our N95 respirators as FDA cleared? How should we do if we want to be FDA cleared eventually?
@greenstar3411
@greenstar3411 3 жыл бұрын
Emergency Auth?
@andybvt
@andybvt 3 жыл бұрын
here are 2 stories 1) Typical client payout for product liability is 8% 2) not a single lawyer would ever stand up in congress and try to stop any of these products being produced because these injuries produces millions of dollars for this industry every year.
@jackmomesso
@jackmomesso 4 жыл бұрын
FDA help American company and push down other , is it normal ???.