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)] SubmissionsJuly 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 ComponentsJuly 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.
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 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
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."
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
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
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 PwCJune 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.
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 AmericansJune 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:
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 GERDJune 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 SurgeryJune 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.
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.
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.
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,...
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Cefepime:Label Change- Risk of Seizure in Patients Not Receiving Dosage Adjustments for Kidney ImpairmentJune 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.
Ultrasonix Medical Corporation has received approval from the US Food and Drug Administration for its SonixGPS technology for Vascular Access procedures.
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...
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...
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 ConditionsJune 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...