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What Matters February: MedTech News You Need to Know

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February 07, 2018

Overheard at GMM HQ

"Virtual Reality surgery sounds cool, but when will they invent VR exercise so I can lose weight without working out?" - Mia Benenate, contemplating one of 2018's hot topics in surgery.


WHAT THE INDUSTRY IS BUZZING ABOUT

GET UP OFF OF THAT THING

This just in: Exercise is good for you. More specifically, sitting is bad for you. A new study in Obesity found that the more time people spent sitting down, the more "invisible fat" they had. 

WTF IS "INVISIBLE FAT?"

Also known as visceral fat, the fat that surrounds internal organs has been linked to increased risk for chronic diseases like type 2 diabetes and heart disease. So even though you can't see it like cellulite, it's there, and it's also the worst type of fat.

THE 411

Not surprisingly, dangerous visceral fat was highest in study participants who got less than the recommended 150 weekly minutes of exercise. Moral of the story: Break up long periods of sitting, get a couple hours of exercise every week, get some sun, and call your mom more often.

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THE ONLY TWO THINGS YOU CAN COUNT ON...

Death and taxes, right? Well, not if Senators Elizabeth Warren and Ed Markey have their way. The Massachusetts Dems recently unveiled legislation that would eliminate the 2.3% excise tax on medical devices that has been part of the Affordable Care Act (ACA). So I guess there's only one thing you can count on. Wow, this just got dark.

SINCE WHEN DO DEMS SLASH TAXES?

The "No Taxation on Device Innovation Act" would offset the cost of repeal by ending a projected $29 billion in tax breaks over the next decade for oil companies, according to Warren and Markey. Because ACA and tax legislation weren't heated enough already, let's get the oil companies involved, shall we?

THE 411

There are more than 6,500 medical device companies in the U.S. that provide about two million jobs nationally with about 82,000 of those jobs in Massachusetts. The Senators contend that repealing the device tax would remove an undue burden on small businesses and device innovation.

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GIMME A MINUTE

The FDA hit pause on a move to implement new regulations surrounding how the agency determines a medical product's intended use, stating more time was needed to review the feedback it received on the proposed changes. Device and pharma companies, who found the potential updates unclear, said, "take all the time you need."

JUST A SMOKE SCREEN?

The proposed changes were part of a final rule notice that also included clarification on when tobacco products would be regulated as medical products. To ensure that the final rule goes into effect, the FDA has decoupled the intended use language from the new tobacco rule. Some drugs make you better, some drugs make you worse.

THE 411

In the meantime, it's business as usual for device and pharma companies when it comes to the types of evidence that may be considered in determining a medical product's intended uses. Carry on, guys.

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GOOD TO KNOW

The good news is that Ikea is bringing truly impressive innovation to their ads. The bad news is that it's in the form of urinating—yep, you read that right—on the ad to reveal a coupon for a crib if you're pregnant. Congratulations?

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