Government joins the drug development business (Morning Read)

Among today’s current medical news: President Obama’s new plan to increase drug development, tighter regulations on external defibrillators; an obligatory healthcare reform update; the Super Angels phenomenon; healthcare jobs continue to grow; the best of the pharma blogs; a soft landing for Boston’s Paul Levy; and a new documentary on lobbying healthcare in the United Kingdom.

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Electronic medical records system an increasing part of doctors’ plans, studies say

An increasing list of hospitals and doctors are planning to adopt an electronic medical records system, according to a survey by the Centers for Disease Control and Prevention’s National Center for Health Statistics. Thirty percent of all physicians now use electronic medical records — a nearly 50 percent jump since 2008.

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Hospital industry hurting from too much regulation, says AHA

The American Hospital Association says that overbearing regulation and an overly aggressive Dept. of Justice is hurting the hospital industry.

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Medical device tax repeal effort gathering steam (or at least huffing and puffing)

Fresh off his vote to repeal healthcare reform, Minnesota Congressman Erik Paulsen is circulating a “Dear Colleague” letter hoping to gather sponsors and resurrect his bill to repeal the medical device tax (called the Defend Medical Innovation Act).

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510(k) changes get approval (pending implementation) from AdvaMed

New 510(k) changes should help the approval of new innovative medical devices, according to the Advanced Medical Technology Association. What will be critical is how well and how quickly these changes are implemented.

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Medical device industry’s future will be guided by Tea Party

The House Energy and Commerce Committee has broad oversight over several regulatory bodies, including the Food & Drug Administration and the Centers for Medicare and Medicaid Services. The GOP-controlled committee is chaired by Rep. Joseph Pitts (R-Pa.), and Rep. Michael Burgess (R-Texas) was named vice chair of the committee.

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FDA 510(k) scorecard: Medical device industry 25, feds 0

Twenty-five proposed steps that will change the 510(k) program that brings new innovative medical devices to market were almost universally agreeable to the device industry. Most of the controversial decisions were put on hold — a move that reformers in the current administration could come to regret when they try to re-initiate those aggressive changes.

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FDA 510(k) reaction: Center for Devices and Radiological Health

Dr. Jeffrey Shuren: New innovative medical devices coming out of the United States will have a better chance to compete against medical device companies in Europe and throughout the world thanks to new changes in the 510(k) process.

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FDA 510(k) reaction: The entrepreneur

Bob Schmidt is a medical device entrepreneur who has started several companies, including Cleveland Medical Devices (CleveMed), Orbital Research, Neurowave Systems and Flocel. Schmidt said this about today’s proposed changes to the U.S. Food and Drug Administration’s 510(k) program:

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New FDA 510(k) medical device reviews will now be ‘smarter’

The U.S. Food and Drug Administration revealed Wednesday 25 steps it says will bring about a “smarter” 510(k) review program for medical devices. The goals of the new guidelines are to support innovation, keep jobs in the U.S. and quickly bring safe and effective medical technologies to patients.

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