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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.

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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...

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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.

Summary Information for: Access & #xae; Hybritech p2PSA on the Access Immunoassay Systems

June 20, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Access® Hybritech p2PSA on the Access Immunoassay Systems (P090026).

Consumer Information on: Access & #xae; Hybritech p2PSA on the Access Immunoassay Systems - P090026

June 20, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

The Access® Hybritech p2PSA on the Access Immunoassay Systems is an automated laboratory test that measures how much [-2]proPSA a man has in his blood.

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Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis

June 20, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

This draft guidance document was developed as a special control guidance to support the reclassification of the Implanted Blood Access Devices for Hemodialysis into class II (special controls). The device, as proposed, is intended to provide access to a..

Consumer Information on: PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) - P110010/S001

June 18, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments

The PROMUS Element stent is a metal stent with the drug everolimus contained in a thin coating on the stent?s surface. The PROMUS Element stent is mounted on a folded balloon attached to a catheter delivery system for placement into a coronary artery...

Summary Information for: PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire)

June 18, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P110010S001).

Add Cyber Security Evaluation to Device Design Process: Expert

June 15, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Medical devicemakers that don’t audit their products for computer security could be putting patients at risk, a cyber security expert says.

Grassley: FDA Unresponsive to Requests for & #8216;FDA Nine & #8217; Records

June 15, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Congressional lawmakers say the FDA is holding up their investigation into reports the agency monitored the personal emails of employees who voiced product safety concerns to Congress, noting that almost five months have gone by without an agency response to a request for key documents.

PMA Final Decisions for April 2012

June 15, 2012 9:30 am | by U.S. Food & Drug Administration | News | Comments

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for April 2012.

Ethicon Asks FDA for 120 Days to Pull Vaginal Mesh From Market

June 8, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Johnson & Johnson’s (J&J) Ethicon unit will halt sales of some vaginal mesh products implicated in a class action lawsuit, but says it needs time to conduct the withdrawal properly.

Device Tax Repeal Passes House, Industry Takes Battle to Senate

June 8, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Opponents of the medical device excise tax, mandated in the 2010 Affordable Care Act, are one step closer to repealing the contentious measure, after the House voted 270-146 to pass H.R. 436, the Protect Medical Innovation Act.

Digestive 3 in 1 Health Liquid Dietary Supplement: Recall - Potential for Contamination With Salmonella

June 7, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments

Risk of serious and sometimes fatal infections, especially in young children, frail or elderly people, and others with weakened immune systems.

Wrinkle Fillers Approved by the Center for Devices and Radiological Health

June 7, 2012 7:30 am | by U.S. Food & Drug Administration | News | Comments

FDA approval is based on the review of data collected from controlled clinical studies that evaluated the safe and effective use of the wrinkle fillers when injected into specified areas of facial tissue. More information about the data FDA reviewed to...

Introvale (levonorgestrel and ethinyl estradiol) Tablets: Recall - Packaging Flaw

June 6, 2012 1:30 pm | by U.S. Food & Drug Administration | News | Comments

Risk of an unintended pregnancy for a patient taking the wrong tablet over several days.

Device Tax Repeal Measure Passes Committee, Sent To House Floor

June 1, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

The House Ways & Means Committee Thursday approved legislation, H.R. 436, to repeal the medical device excise tax — delighting industry.

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