Wellness tech company in talks with Fda about machine that could have prompted injury, loss of life

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Health-related engineering corporation Avanos has issued a voluntary discipline correction for a very important hospital instrument that could have led to injury or even demise. 

Avanos at first explained to Fox Information Digital that the organization is in an “ongoing dialogue” with the Food items and Drug Administration (Food and drug administration) on the subject and “can not comment,” but afterwards added that “the Fda has not asked for that Avanos perform a solution recall, and we have no expectation that it will do so.”

The Cortrak 2 Enteral Obtain Procedure assists healthcare vendors fit feeding tubes safely and securely into a individual so they steer clear of distributing foodstuff into delicate places of the body. On the Avanos website, it advertises the Cortrak 2 process as “a time-preserving resolution that positive aspects nurses of all stages, dieticians, and GI and ICU medical doctors.” 

The company states that other methods can lead to “amplified pneumothorax danger, feeding delays, numerous x-rays and transports,” implying their technique avoids these difficulties with “actual-time spot information” and “on-display visualization” on tube placement with a lowered need to have for x-ray confirmation. 

But a recognize posted by the Canadian governing administration less than its “Recollects and safety alerts” web site advises medical practitioners that Avanos executed a voluntary subject correction for the Cortrak 2 thanks to “modifications to the labeling of the device.”

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“Reports of injuries and client deaths linked to misplacement of nasogastric feeding tubes though operating the unit for every labeled instructions for use (IFU) and supposed use have been gained,” the detect said. 

A copy of the industry correction see dated March 21, 2022 and obtained by Fox News Digital states that there have been studies of 60 accidents and 23 fatalities thanks to misplacement of the method. The discover implies that the hospital or person “confirm placement of the NG/NI tubes per institution protocol.” The Food and drug administration said in an on line see that the agency had acquired 51 health-related device reviews that involved 11 described fatalities right after pneumothorax – or a lung collapse – events transpired. 

The observe also points out that the company will retire the “Nameless Account Manner,” which, according to a British briefing recognize, logs the full placement online video quickly but does not file it. The alternative manner, “Accounts Method,” saves the videos to an external USB flash travel. 

Fox Information attained out to the Fda for comment.

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Avanos previously faced lawful concerns with the Department of Justice when it labeled its surgical robes as giving the highest amount of defense against fluid and virus penetration. Avanos agreed to a deferred prosecution settlement and to fork out $22 million, which covered sufferer payment and criminal penalties. 

Mark Gardner and Theo Thompson, lawyers who focus in MedTech & Pharma, instructed Fox

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Fitness May Matter More Than Weight Loss for Health and Longevity

Dec. 28, 2021 — Numbers are easier. That may be why a person’s weight — and the desire of millions of people to lose weight — is the first topic under discussion when it comes to health and longevity. Not long after you walk into your doctor’s exam room, for example, you’ll step on a scale. It’s usually the first measurement they take, ahead of vital signs like blood pressure and heart rate.

This makes sense. It’s a number, which means it’s easy to see if your weight has changed in either direction since the last time they weighed you.

But there’s an unintended result: You come away thinking that your weight is every bit as important as how well your heart and blood vessels are working, and that losing a few pounds will improve your health in tangible, long-lasting ways.

Yes, weight loss has proven health benefits. But should weight loss be the top priority for everyone classified as “overweight” or “obese” — a demographic that now includes three-quarters of all American adults?

“The weight loss message is not, and has not been, working,” says Glenn Gaesser, PhD, a professor of exercise science at Arizona State University.



He’s among a growing number of health experts who believe that weight loss may not be the most important benefit when it comes to adopting a healthier lifestyle. That’s especially true if you compare it to the benefits of increasing your fitness level, as Gaesser and a co-author did in a recent study.

Intentional weight loss — that is, losing weight on purpose, rather than because of an injury or illness — is usually associated in studies with a lower risk of death from any cause. The effect is most powerful among those with obesity and/or type 2 diabetes.

But here’s an interesting wrinkle: The amount of weight lost doesn’t seem to change the risk of dying. If the weight itself is the problem, why wouldn’t those who lost the most get the biggest risk reduction?


Gaesser is skeptical that the health benefits of weight loss are entirely or even mainly caused by a lower number on the scale. Many clinical weight loss trials — studies in which people take part in a structured program — also include exercise and diet components.

Moving more and eating better are consistently and strongly linked to less risk of death from any cause. And “the health benefits of exercise and diet are largely independent of weight loss,” Gaesser says.

That’s especially true for exercise and living longer. Studies show that increasing physical activity lowers the risk of death from any cause by 15% to 50%, and the risk of heart disease by up to 40%.

The change is even more dramatic when you exercise with enough effort to improve your heart fitness. Moving from the lowest fitness category to a higher one can cut your mortality risk by

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