What Matters: December's MedTech News You Need to Know

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WHAT THE INDUSTRY IS BUZZING ABOUT

AN APPLE A DAY KEEPS THE DOCTOR AWAY?

Apple CEO Tim Cook recently shut downspeculation that the Apple Watch might one day be morphed into some sort of medical device, despite the fact that it’s poised to gather so much relevant personal info as the company’s only wearable device.

THERE'S AN APP FOR THAT

Cook did indicate, however, that Apple just might get into the medical device game, after all, albeit with a brand new product. “Maybe an app, maybe something else,” he, um, clarified.

THE 411

FDA approval is required for any device that is intended to diagnose or treat a condition, to which the Apple Watch says, “Ain’t nobody got time for that.” Instead, it appears that Apple might soon unveil their first product that would require FDA approval.

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IS THIS THING ON?

The FDA, much like your aging grandparents, is vowing to up its technology IQ. As more and more medical devices utilize network connectivity, the threat of hacking is at an all-time high (exhibits A and B).

CYBER SAFETY FIRST

The new goal is part of a recently released Office of Inspector General work plan for the upcoming fiscal year. The office plans to examine whether the FDA’s oversight is enough to effectively protect patient health information in the devices, as well as ensure safety.

THE 411

Computerized medical devices that are integrated with electronic medical records are an open invitation for hackers to get their anti-HIPAA on. The FDA’s New Year’s resolution is to prevent that. Also, your grandpa’s going to learn about "selfie mode."

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NO KICKSTARTER NEEDED

In one of the biggest corporate deals ever, upon regulatory approval, Pfizer will purchase Allergan for approximately $160 billion creating the world's largest pharmaceutical giant. The merger could potentially earn them a valuation of $300 billion and is expected to close by the end of 2016. The happy couple is registered at Tiffany’s, obviously.

WILL YOU BE FILING JOINTLY?

One upside for Pfizer is that the deal is structured as an inversion, so Pfizer will be granted headquarter-status in Ireland, where tax rates are roughly one-third those of the U.S. On the flipside, the Obama administration tried to crack down on inversion deals when Medtronic bought Ireland-based Covidien last year, so it could get tricky.

THE 411

Pfizer took Allergan out to dinner and now everyone’s speculating about when the wedding will be (and how much it will cost). Allergan’s been around the block so this would be a big deal for everyone.

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GOOD TO KNOW

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