suzanne-hodsden-articles
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FDA Clears Siemens' “Budget Friendly” MR System For Small to Medium-Sized Hospitals
2/15/2017
Siemens Healthineers announced FDA approval for its new 1.5 Tesla MRI system, which uses an algorithm to decrease acquisition times, meaning the system experiences less motion interference and is less likely to require a rescan.
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India To Split Med Device Industry From Pharma, Revisit Free Trade Agreements
2/14/2017
Moves under consideration include separation of medtech from its pharmaceutical industry, increased government funding for the medtech industry, and the renegotiation of existing free trade agreements (FTAs) with other countries. The device industry also is asking the government to recognize local regulatory certifications, in addition to the currently accepted FDA approval from the U.S.
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“Hair-Like” Brain Implant Could Simulate Vision In The Blind
2/10/2017
Harvard scientists are testing a neural prosthesis that uses arrays of microscopic coils to generate magnetic fields that can target specific regions of the brain, such as the visual cortex to simulate sight.
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FDA Approves Abbott's MRI-Compatible Wireless Pacemaker
2/9/2017
Abbott has announced that the FDA approved MR-conditional labeling for its Assurity pacemaker, touted by the company as the “world’s smallest and longest-lasting” MRI-compatible wireless pacemaker.
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U.K. To Increase Regulatory Fees For Medtech Manufacturers, Notified Bodies
2/8/2017
The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has announced that it will move forward with its proposal to increase and/or add fees charged to medical device makers applying for regulatory approval for designations, audits, registrations, and clinical investigations. The fees are intended to offset regulatory costs, and will undergo regular audits to ensure they remain fair.
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Becton Dickinson CEO Details Three-Pronged Strategy To Drive Sustainable Growth
2/7/2017
Becton Dickinson’s (BD) 2017 Q1 report topped Wall Street projections for both sales and earnings, despite a 4.4 percent dip in revenues compared with 2016 that resulted from the divestiture of its respiratory device unit.
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Abbott Diagnostic Assay Authorized To Test Whole Blood Samples For Zika Virus
2/6/2017
Abbott announced that the FDA has extended the company’s Emergency Use Authorization (EUA) for a Zika virus assay to include use with whole blood samples, making it the only diagnostic to receive such an expanded designation.
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Gore's Balloon Stent Graft First To Gain FDA Approval For PAD In Iliac Artery
2/2/2017
FDA announced approval of W.L. Gore & Associates’ expandable balloon stent graft for treatment of peripheral artery disease (PAD) lesions in the iliac artery and at the aortic bifurcation. It is the first technology of its kind approved for this expanded indication. In clinical studies, the Gore Viabahn VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) demonstrated immediate and nine-month safety and efficacy endpoints in a variety of challenging peripheral artery disease (PAD) presentations.
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Senate Democrats Boycott Committee Hearing For Trump's HHS Nominee
2/1/2017
In a surprise move that “shocked” Senate Republicans, Senate Democrats boycotted committee hearings for both the nominee for Treasury secretary and the director of Health and Human Services (HHS), citing unanswered questions regarding the nominees’ personal finance decisions and possible insider trading. Democrats claim that HHS nominee Rep. Tom Price (R-Ga.) received “privileged” information — a claim the company disputes — and bought discounted stock in an Australian biomedical company, contradicting his testimony at Senate hearings in January.
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Liquid Lens Technology Enables Smart Glasses To Focus Automatically
1/31/2017
Novel eyeglass technology developed at the University of Utah (UU) uses “liquid lenses” to adjust focus based on where the wearer is looking. The glasses are connected to a smartphone app and can be wirelessly customized to suit individual corrective lens prescriptions.