Advertisement
Regulatory
Subscribe to Regulatory
View Sample

FREE Email Newsletter

Device Tax: We Need Action by Summer, Paulsen Says

February 4, 2013 3:43 pm | by Mass Device | News | Comments

Medical device industry advocate Rep. Erik Paulsen (R-Minn.) says Congress needs to act on the medical device tax by "late spring, early summer" this year. Rep. Erik Paulsen (R-Minn.), an unrelenting opponent of the medical device tax that took effect at the start of the year, still sees avenues for repeal tied to larger discussions of corporate tax reform. News Well, Capitol Hill, Medical Device Taxread more

Sunshine Act Survey: More Than 50% of Physicians Unprepared

February 4, 2013 3:05 pm | by PR Newswire | News | Comments

PORTSMOUTH, N.H., Feb. 4, 2013 /PRNewswire/ -- MMIS' third annual survey of doctors and their knowledge of the Sunshine Act found that physicians are actually less informed than they were one year ago. With the release of the final rules implementing the Sunshine Act on February 1,...

Sunshine rules finally drop

February 4, 2013 7:29 am | by Mass Device | News | Comments

The White House finally releases long-awaited Sunshine Act rules to regulate and monitor the financial relationships between doctors and the healthcare industry. The Obama Administration finally released long-awaiting transparency guidelines governing the relationships between doctors and medical device and drug makers. The rules are more than 15 months late...

Advertisement

Bringing Critical Mass to the Movement to Repeal the Medical Device Excise Tax

February 1, 2013 2:37 pm | by Thomas Allen Malm | News | Comments

Strategy consultant and author, Thomas Allen Malm, is proposing a way to shift the burden of the medical device excise tax (MDET) that he says will open a new dialog and solve two problems at once. He understands the optimism of manufacturers and industry associations growing from the number of Representatives in Congress crossing party lines to support the repeal of the 2.3% tax...

November/December 2012 Digital Edition

January 29, 2013 3:50 pm | Digital Editions | Comments

The November/December 2012 cover story, "Industry Forecast," highlights the significant topics for the industry in 2013 and shares the thoughts of leaders from the community. In "Meeting the FDA's Mandates for Unique Device Identification," technology is reviewed that can aid in ensuring manufacturers are in compliance to this coming regulation.

HSCA Finds Evidence That Some Medical Device Manufacturers Shifting Cost Burden of Excise Tax Directly to American Hospitals, Healthcare Providers, Patients and Taxpayers

January 25, 2013 10:22 am | by Healthcare Supply Chain Association | News | Comments

The Healthcare Supply Chain Association (HSCA) and its group purchasing organization (GPO) members today expressed alarm over evidence that some medical device manufacturers are shifting the burden of the medical device excise tax directly to American hospitals and other healthcare providers.

Perspectives on Industry Insight, Part II

January 17, 2013 12:00 am | by MDT Staff | Medical Murray, Inc. | Articles | Comments

  Would you please comment on the medical device industry as we move into 2013? Contract manufacturing continues to shift from just “manufacturing” to include a full road map of your finished products, including design, test, manufacturability, and distribution.  

Perspectives on Industry Insight, Part I

January 16, 2013 12:00 am | by MDT Staff | Honeywell Sensing And Control, Portescap, D.L.S. Electronic Systems, Inc. | Articles | Comments

Would you please comment on the medical device industry as we move into 2013? The need for medical device manufacturers to have product recall plans in place was reaffirmed by the release of the latest figures on medical device unit recalls. According to the quarterly ExpertRECALL Index released August 22, 2012, over 123 million medical device units were recalled in the second quarter of 2012...

Advertisement

With Patient Health at Stake, Medical Equipment Industry Needs to Improve Supply Chain Visibility

January 4, 2013 2:35 pm | by Armin Meissner | Blogs | Comments

There are few industries as tightly interwoven with life and death issues as medical equipment. Getting everything right; from adherence to regulations to on-time product deliveries to perfectly performing products, is paramount. Complete transparency throughout the medical equipment supply chain is an absolute necessity. Transparency cannot be a part-time or partial commitment but rather, it must be an all-out endeavor to achieve safer and more effective patient healthcare.

Cook Medical Meets Industry Date for GS1 Global Trade Item Number

January 2, 2013 11:38 am | News | Comments

The health care industry is adopting a set of standards to make supply chain easier for hospitals and Cook Medical is ready for the change. Almost ten years ago, Cook Medical realized all of its manufacturing companies were using different product numbering systems. The lack of standards caused confusion and inefficiency in shipping and tracking product.

List of Nucleic Acid Based Tests

December 10, 2012 12:00 am | by U.S. Food & Drug Administration | News | Comments

This is a list of nucleic acid-based tests that have been cleared or approved by the Center for Devices and Radiological Health. These tests analyze variations in the sequence, structure, or expression of deoxyribonucleic acid and ribonucleic acid...

FDA announces public-private partnership to develop regulatory science that will speed patient access to new medical device technologies

December 3, 2012 11:11 am | News | Comments

The U.S. Food and Drug Administration announced today that it is part of the first public-private partnership to promote medical device regulatory science with a focus on speeding the development, assessment, and review of new medical devices.

Another Tax Column…

October 18, 2012 3:55 pm | by Sean Fenske | Blogs | Comments

I tried hard to find a topic other than the coming medical device excise tax to write about, however, either my brain didn’t have any more room to fit another topic or there’s just not that much else going on in the medical device industry (which is much less likely). I was also hesitant to write the column because, unlike with the web, there is a period of time that passes from the moment I complete the column until the time it is published and mailed where the content is out of my hands while outside forces can wreak havoc on the topic and the timing of its appearance.

Advertisement

Medical Device Safety Monitoring and Reporting

October 2, 2012 11:15 am | Events

Given that the malfunction of a device can lead to fatality, the need to ensure these devices are safe and are monitored effectively is crucial. Any complaints on devices need to be monitored so that if there is a need to recall the device, it can be done effectively and quickly, without any further impact to patients.

New Legislation Would Establish Market-Based Pricing in Medicare for Home Medical Equipment and Services

September 25, 2012 2:11 pm | by PRNewswire-USNewswire | News | Comments

The American Association for Homecare endorses a bill introduced last week in the House of Representatives that would implement market-based pricing for home medical equipment and services such as oxygen therapy, wheelchairs, and other durable medical equipment and services.

MDET: A New Acronym to Learn

September 18, 2012 9:17 am | by PRNewswire | News | Comments

Each Autumn, with an eye on the winter months ahead, squirrels gather nuts to prepare for the inevitable change. Hospitals, medical facilities, doctors and long term care facilities may be doing the same this Fall, stocking shelves and purchasing items from their wish list and budgets before a new tax on most medical products goes into effect. 

2012 RAPS: The Regulatory Convergence

August 31, 2012 10:33 am | Events

It’s time to turn questions into answers. Ideas into accomplishments. Time to rise up and meet the challenges of a global regulatory environment.

Markey, Merkley Call on FDA to Reform Medical Devices Databases

August 15, 2012 2:30 pm | News | Comments

Today, Representative Edward J. Markey (D-Mass.) and Senator Jeff Merkley (D-Ore.) sent a letter to the Food and Drug Administration (FDA) calling on the agency to overhaul and streamline the federal databases that provide information to the public about the safety of medical devices that rarely undergo clinical trials in humans before being sold on the market. In the absence of legislation that would close the current loophole...

Covidien recalls tracheostomy tubes

August 15, 2012 12:00 am | by Mass High Tech: The Journal of New England Technology | News | Comments

Medical device firm Covidien plc (NYSE: COV) has recalled several lots of cuffed Shiley brand tracheostomy tubes, which are inserted into patients’ windpipes to help them breathe when they can not do so on their own. The recall followed customer complaints about leakage or disconnection between inner and outer cannulae during mechanical ventilation of patients.

Verify Brand Supports the Proposed FDA Unique Device Identification (UDI) System for Medical Devices

July 26, 2012 11:48 am | News | Comments

On July 10, 2012, the Food and Drug Administration released its proposed rule for Unique Device Identification (UDI) of medical devices in the United States. The system focuses on creating standardized device identifiers that are applied to packaging and devices...

FDA scientist's lawsuit history raises eyebrows

July 20, 2012 12:47 pm | by Mass Device | News | Comments

The FDA scientist behind allegations of in-house surveillance and overlooked safety concerns at the federal watchdog agency is no stranger to lawsuits. One of the whistle-blowing scientists who accused the FDA of persecuting and spying on employees has a few lawsuits under his belt, a charge that may damage his credibility in an ongoing case against the federal watchdog agency. Radiologist Dr. Robert Smith, a member of the so-called "FDA 9," joined colleagues in suing the FDA and its leadership for alleged retaliation against them when they raised questions agency decisions about some mammogram and colonoscopy systems.

HSCA Applauds FDA for Releasing Proposed Rule on Medical Device Identifiers

July 9, 2012 11:45 am | News | Comments

Healthcare Supply Chain Association (HSCA) President Curtis Rooney today released the following statement regarding FDA’s release of a proposed rule on a Uniform Device Identifier (UDI) for implantable medical devices...

Medical Device Tax: The road to 60 repeal votes

June 29, 2012 4:26 pm | by Mass Device | News | Comments

MassDevice.com assesses thechance that the U.S. Senate will vote to repeal the medical device tax. Now that the U.S. Supreme Court has upheld healthcare reform, hopes for a repeal of the medical device tax contained in the law rest with the U.S. Senate and a bill sponsored by Sen. Orrin Hatch (R-Utah) to do away with the 2.3% levy. News Well, Medical Device Taxread more

SCOTUS Reaction Survey: 66.5% of Primary Care Physicians Fear Individual Mandate Won’t Work

June 29, 2012 10:58 am | News | Comments

In an MDLinx survey of U.S. primary care physicians taken Thursday following the Supreme Court’s upholding of the Affordable Care Act (ACA) ruling, 66.5 percent said that they did not believe the law could achieve its objective of 100 percent healthcare coverage for Americans.

Supreme Court Decision to Uphold Healthcare Law Means “Game On” for Health Industry: Crunch Time for Those Who Waited, Says PwC

June 29, 2012 9:51 am | News | Comments

Today’s Supreme Court ruling upholding the Affordable Care Act gives extra punch to the market forces pushing healthcare away from fee-for-service and re-injects a new sense of urgency into the transformation of the health industry, according to a report published today by the Health Research Institute (HRI) of PwC US.

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading