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Greatbatch proposes to mostly exit Switzerland for Indiana, Mexico

July 3, 2012 11:38 am | by Mass Device | News | Comments

Greatbatch, blaming a slumping orthopedics market and downward pricing pressure from customers, proposes to lay off 90% of its workers at 2 plants in Switzerland, aiming to relocate most of the operations to Indiana and Mexico. Greatbatch (NYSE:GB) said it wants to largely shutter a pair of plants in Switzerland and relocate their operations to Ft. Wayne, Ind., and Tijuana, Mexico. News Well, Mergers & Acquisitions, Orthopedics, Wall Street Beatread more

Guidance for Industry and FDA Staff - Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions

July 3, 2012 12:00 am | by U.S. Food & Drug Administration | News | Comments

This guidance document provides recommendations to industry, systems and service providers, consultants, FDA staff, and others regarding clinical performance assessment of computer-assisted detection (CADe1) devices applied to radiology images and...

Manufacturing Source Provides Product Enhancements And Precision Machining Of 22 Different Components

July 2, 2012 4:36 pm | by Liam Quirke | Articles | Comments

Marshall Manufacturing Company was chosen by Dr. Emil Verban to manufacture the patented Drillstops®, which increase the safety and precision of dental implant procedures. In use, a tiny set-screw locks the stop to the drill bit, the stop rotates with the drill bit while avoiding tissue damage as the drill penetrates the bone.


NeuroSigma Receives Global Quality Control Certification

July 2, 2012 3:53 pm | News | Comments

Today NeuroSigma, Inc., a Los Angeles-based medical device company, announced that it received ISO 13485: 2003 certification, indicating that it operates a Quality Management System for the design, manufacturing and distribution of its external Trigeminal Nerve Stimulation (eTNS™) system for the treatment of neurological and neuropsychiatric disorders.

InVivo targets $22B injectable pain-relief market | Regulatory Roundup

July 2, 2012 3:06 pm | by Mass Device | News | Comments

InVivo Therapeutics engages the FDA to discuss the regulatory path for its injectable hydrogel for neurological pain, anticipating an annual market potential of $22 billion.  InVivo engages the FDA to move forward on injectable pain-relief hydrogen, aims for $22B yearly market News Well, 510(k), Food & Drug Administration (FDA), Pain Management, Regulatory/Complianceread more

Study on Using the NanoKnife System to Treat Liver Tumors Adjacent to Blood Vessels

July 2, 2012 10:18 am | News | Comments

AngioDynamics, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced the publication of a study in the Journal of the American College of Surgeons, titled, "Ablation of Perivascular Hepatic Malignant Tumors with Irreversible Electroporation."

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

FSS lands extended CE Mark for FlexStent | Regulatory Roundup

June 29, 2012 2:21 pm | by Mass Device | News | Comments

Flexible Stenting Solutions touts CE Mark approval for additional sizes of its FlexStent self-expanding iliac stents.  FSS touts CE Mark win for new self-expanding stent sizes News Well, 510(k), CE Mark, Food & Drug Administration (FDA), Regulatory Roundup, Regulatory/Complianceread 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.


EndoGastric Solutions Announces Second Randomized Controlled Trial Comparing TIF Procedure to PPI Therapy for the Treatment of GERD

June 28, 2012 2:02 pm | News | Comments

EndoGastric Solutions® (EGS), the leader in endoluminal treatment of Gastroesophageal Reflux Disease (GERD), today announced the start of the TIF versus Medical Proton Pump Inhibitor (PPI) Management of Refractory GERD Symptoms (TEMPO) trial. TEMPO, the second in a series of randomized trials involving TIF, is designed to assess the safety and efficacy of the procedure—performed using EndoGastric Solutions’ EsophyX® device—as compared to PPI therapy to treat bothersome symptoms associated with chronic GERD.

NLT SPINE Reports Positive Clinical Results for PROW FUSION, Its Lumbar Interbody Fusion Device for Minimally Invasive Spine Surgery

June 28, 2012 1:57 pm | News | Comments

NLT SPINE, a developer of products for Minimally Invasive Spine Surgery (MISS) and percutaneous procedures, announced today that initial results from clinical experience with its PROW FUSION device are highly positive.

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,...

Applying Tech: Cardiovascular

June 27, 2012 5:38 pm | Articles | Comments

How are you influencing cardiovascular devices?

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.

FDA approves SonixGPS needle guidance technology for vascular access procedures

June 26, 2012 5:49 am | News | Comments

Ultrasonix Medical Corporation has received approval from the US Food and Drug Administration for its SonixGPS technology for Vascular Access procedures.

Pitt Develops Biodegradable Artery Graft to Enhance Bypass Surgeries

June 25, 2012 10:58 am | News | Comments

With the University of Pittsburgh’s development of a cell-free, biodegradable artery graft comes a potentially transformative change in coronary artery bypass surgeries: Within 90 days after surgery, the patient will have a regenerated artery...

Cook Medical Sponsors First Clinical Study to Examine New Endovascular Technique

June 25, 2012 10:30 am | News | Comments

Clinical investigators are for the first time examining the retrograde tibiopedal interventional approach, an endovascular technique that has the potential to reduce the rate of leg amputations by as much as 50 percent in patients with critical limb ischemia...

Discovery of ‘Master Molecule’ Could Improve Stem Cell Treatment for Heart Attacks

June 25, 2012 7:34 am | News | Comments

Johns Hopkins researchers have discovered that a single protein molecule may hold the key to turning cardiac stem cells into blood vessels or muscle tissue, a finding that may lead to better ways to treat heart attack patients.

Epilepsy Organizations Award Funding for New Devices to Treat, Detect, and Monitor Epilepsy Conditions

June 25, 2012 6:45 am | News | Comments

The Epilepsy Therapy Project (ETP) and the Epilepsy Foundation (EF) today announced the latest grant recipients of their New Therapy Grants Program, a unique joint venture of the two non-profit epilepsy organizations to advance clinical development...

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