Euro device makers cry 'nay' on FDA-like proposal for medtech review

Euro device makers cry 'nay' on FDA-like proposal for medtech review-massdevice.com:
Medical device makers warn against new guidelines that would establish a central FDA-like body to oversee pre-market medtech review for the European Union.

Orrin Hatch may not be a lock for Finance chairman

Orrin Hatch may not be a lock for Finance chairman-politico.com:
Sen. Orrin Hatch has made the pitch countless times to Utah voters: Send him back to Washington for another term, and he’ll become chairman of the mighty Senate Finance Committee.
But first, he may have to convince Iowa Sen. Chuck Grassley.







 

Cutting jobs over device tax is "nonsense," says medtech CEO

Cutting jobs over device tax is "nonsense," says medtech CEO-massdevice.com: Speech therapy devices maker Glottal Enterprises' CEO says that using the 2.3% medical device tax to justify layoffs is "nonsense" and little more than a political strategy to attack the Affordable Care Act.

U.S. medtech lobbies join forces to blaze trails in China

U.S. medtech lobbies join forces to blaze trails in China-massdevice.com:


The Medical Imaging & Technology Alliance and the Advanced Medical Technology Assn. join forces to reduce medical device trade barriers with China.

Medical devices a key driver in skyrocketing healthcare costs, report says

Medical devices a key driver in skyrocketing healthcare costs, report says-massdevice.com

Advances in medical technology that replace existing devices with more expensive versions are among the top factors in skyrocketing U.S. healthcare spending, according to the Bipartisan Policy Center.

Medical device tax: Sen. Hagan says Congress should work on repeal

Medical device tax: Sen. Hagan says Congress should work on repeal-massdevice.com:
Members of Congress should work together to find a financially responsible way to repeal the medical device tax, Sen. Kay Hagan tells the North Carolina Chamber of Commerce.

Europe's more stringent medtech review may bring costly delays

Europe's more stringent medtech review may bring costly delays-massdevice.com:


The European Commission's updated medtech review guidelines, expected to drop this month, may take some cues from the FDA in bolstering regulatory oversight - and potentially delaying market access.

Report: Medical device companies won't realize benefits from healthcare reform

Report: Medical device companies won't realize benefits from healthcare reform-massdevice.com: A report from an Orange County, Calif., investment bank pokes holes in rationale that healthcare reform will be a boon to medical device companies.

Paulsen presses IRS on medical device tax regulations

Paulsen presses IRS on medical device tax regulations-massdevice.com: Rep. Erik Paulsen (R-Minn.) presses the IRS on the final rules for implementing the medical device tax, a 2.3% levy on U.S. revenues set to begin Jan. 1, 2013.

Senator irked by hazy timeframe on Sunshine Act

Senator irked by hazy timeframe on Sunshine Act -modernhealthcare.com: A CMS official indicated that a long-awaited final rule on a physician payment reporting program will begin requiring data collection in 2013—a vague enough answer to draw a senator's criticism.

FDA Pushes Device Surveillance Plan That Could Involve PCORI; Off-Label, Data Access Debated

FDA Pushes Device Surveillance Plan That Could Involve PCORI; Off-Label, Data Access Debated-InsideHealthPolicy.com:
FDA device officials are pushing for a national postmarket surveillance monitoring system that emphasizes Unique Device Identifiers and their incorporation into electronic health records, device registries, modernized adverse event reporting and new methods to analyze postmarket information, laying out the plan in a paper released late last week and discussed at a public meeting Monday (Sept. 10).

Medical devices: FDA's user fee deal is on the rocks

Medical devices: FDA's user fee deal is on the rocks-massdevice.com:

The $610 million deal between medical device companies and the FDA over the user fees paid for product reviews could be in danger as Congress bickers over the federal budget.

AHRQ seeks to tap patients for safety-event data

AHRQ seeks to tap patients for safety-event data -modernhealthcare.com:

The Agency for Healthcare Research and Quality is seeking approval to design and test a system for collecting information from patients about healthcare safety events.

FDA outlines postmarket surveillance plan ahead of public meetings

FDA outlines postmarket surveillance plan ahead of public meetings-massdevice.com:


Ahead of a 4-day public meeting blitz, the FDA released a preliminary proposal for strengthening medical device post-market surveillance.

Hearing to examine IRS enforcement of healthcare reform law provisions

Hearing to examine IRS enforcement of healthcare reform law provisions-modernhealthcare.com:

A House Ways and Means Committee panel next week will hold a hearing on how well-equipped the Internal Revenue Service is to handle enforcement of the healthcare reform law.

Health-Care Goal Should Be Quality, Not Quantity

Health-Care Goal Should Be Quality, Not Quantity- Peter Orszag OpEd for Bloomberg:
The Independent Payment Advisory Board is perhaps the most mischaracterized part of the health- care reform law -- which is saying something, given how many false charges have been hurled at the Affordable Care Act. The IPAB was designed to be a backstop to make sure the health-care system makes a transition from fee-for-service payments to payments based on value.

Peter R. Orszag, vice chairman of corporate and investment banking at Citigroup and an adjunct senior fellow at the Council on Foreign Relations, was President Obama's director of the Office of Management and Budget.

FDA to host Florida conference on long-awaited UDI program

FDA to host Florida conference on long-awaited UDI program-massdevice.com:
FDA regulators invite device makers, GPOs and other healthcare industry stakeholders to a Florida conference on medical device unique device identifiers.