Archive for Medical Device Industry

Your Friday IRS regulation dump: Obamacare’s job-killing medical device tax. (VIDEO)

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Your Friday IRS regulation dump: Obamacare’s job-killing medical device tax. (VIDEO)

Heartbeat Vibrations Power Pacemakers

Though pacemakers require only small amounts of energy (about 1 millionth of a Watt), their batteries have to be replaced periodically, which means multiple surgeries for patients…

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Heartbeat Vibrations Power Pacemakers

Brain Blood Flow And Oxygen Monitored By First-Of-Its-Kind Head Patch

A research team led by investigators at Mayo Clinic in Florida has found that a small device worn on a patient’s brow can be useful in monitoring stroke patients in the hospital. The device measures blood oxygen, similar to a pulse oximeter, which is clipped onto a finger…

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Brain Blood Flow And Oxygen Monitored By First-Of-Its-Kind Head Patch

AdvaMed: MDUFA Agreement Could Be “Game Changer” for FDA, Industry

A compromise reached by the FDA and device industry on medical device user fee reauthorization should benefit both parties and speed patient access to innovative technologies, AdvaMed President Stephen Ubl said.

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AdvaMed: MDUFA Agreement Could Be “Game Changer” for FDA, Industry

Delays in MDUFA Agreement Threaten Omnibus User Fee Bill

Rather than breaking device user fees out of an omnibus bill, House Energy & Commerce Health Subcommittee Chair Joe Pitts (R-Pa.) reportedly has threatened to freeze device fees at current levels for five years if the FDA and industry can’t speed up an agreement on Medical Device User Fee Act (MDUFA) reauthorization.

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Delays in MDUFA Agreement Threaten Omnibus User Fee Bill