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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.

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 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.

Supreme Court Ruling Leaves Medical Device Excise Tax in Place: Kalorama

June 28, 2012 3:06 pm | News | Comments

While supporters and opponents of President Obama’s healthcare reform legislation let out boos or cheers for the recent decision of the United States Supreme Court, one industry will not be pleased, according to Kalorama Information. The healthcare market research publisher says that the medical device industry will face additional costs

Generation Opportunity President Paul T. Conway Statement: Scotus Health Care Decision's Impact on Young Americans

June 28, 2012 2:19 pm | News | Comments

Generation Opportunity President Paul T. Conway, former Chief of Staff for the US Department of Labor and former Deputy Secretary of Health and Human Resources for the Commonwealth of Virginia, has issued the following statement regarding the Supreme Court's decision today on the Patient Protection and Affordable Care Act:

Cook Medical Statement on Supreme Court Ruling on Affordable Healthcare Act

June 28, 2012 2:06 pm | News | Comments

With the U.S. Supreme Court ruling upholding the constitutionality of the Affordable Care Act (ACA), Cook Medical now calls for the U.S. Senate to repeal the 2.3 percent medical device excise tax included in that legislation.

Patients Are the Victors in Affordable Care Ruling, Says American Heart Association CEO

June 28, 2012 12:10 pm | News | Comments

American Heart Association CEO Nancy Brown issued the following statement today on the U.S. Supreme Court's ruling upholding the Affordable Care Act: "The historic decision handed down today will benefit America's heart health for decades to come. Questions about the Affordable Care Act's constitutionality have overshadowed the law's progress. With this ruling, that uncertainty has finally been put to rest.

HSCA Statement on Supreme Court Affordable Care Act Decision

June 28, 2012 11:55 am | News | Comments

Healthcare Supply Chain Association (HSCA) President Curtis Rooney today released the following statement regarding the Supreme Court’s decision to uphold the Affordable Care Act: "Now that the Supreme Court has rendered its decision on the Affordable Care Act and the national conversation can return to healthcare reform centered on cost containment, hospitals and healthcare providers will rely more than ever on the billions of savings that their group purchasing organizations (GPOs) provide every year.

Lilly Statement on Affordable Care Act Ruling by Supreme Court

June 28, 2012 11:21 am | by The Associated Press | News | Comments

Following is a statement from John C. Lechleiter, Ph.D., chairman, president, and chief executive officer of Eli Lilly and Company, regarding today's U.S. Supreme Court ruling to uphold the Affordable Care Act: "Following today's decision by the U.S. Supreme Court on the Affordable Care Act,...

Cefepime:Label Change- Risk of Seizure in Patients Not Receiving Dosage Adjustments for Kidney Impairment

June 26, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

Health care professionals should adjust the dosage of cefepime in patients with creatinine clearance less than or equal to 60 mL/min.

OSC Surveillance Guidance Proves FDA Wrongdoing: Lawyers for Whistleblowers

June 22, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

A new memorandum issued by the U.S. Office of Special Counsel (OSC) instructing federal agencies to ensure their electronic surveillance policies and practices do not deter whistleblowing “confirms” the FDA broke the law when it allegedly monitored the personal emails of...

MDUFA Passes Final House Vote With Few Changes to Device Provisions

June 22, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

The House Wednesday overwhelmingly approved reauthorizing the Medical Device User Fee Act (MDUFA), sending it on to the Senate with a voice vote.

Nidek Medical Products Mark 5 Nuvo, Nuvo 8, and Nuvo Lite Oxygen Concentrators: Class I Recall - Risk of Fire, Loss of Supplemental Oxygen

June 21, 2012 12:30 pm | by U.S. Food & Drug Administration | News | Comments

A capacitor failure may result in a fire hazard and loss of supplemental oxygen, which can lead to serious adverse health consequences, including death.

Class I Medical Device Recall: Nidek Medical Products, Inc., Mark 5 Nuvo, Nuvo 8 and Nuvo Lite Oxygen Concentrators

June 21, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: Capacitor failure may result in a fire hazard and loss of supplemental oxygen. These products may cause serious adverse health consequences, including death.

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