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Intersect ENT dives on Q3 earnings, reimbursement concerns
Shares in Intersect ENT (NSDQ:XENT) yesterday tumbled over 30% over reimbursement woes, despite the medical device maker handily topping expectations on Wall Street with its 3rd quarter results. The...
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Hologic shares lift on Street-beating Q4
Shares in Hologic (NSDQ:HOLX) rose today after the medical device maker topped expectations on Wall Street for its 4th quarter and fiscal year 2016 earnings. The Marlborough, Mass.-based company posted...
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Insulet posts beat-and-raise Q3
Shares in Insulet (NSDQ:PODD) are soaring in after-hours trading after the diabetes device developer posted Street-beating 3rd quarter earnings and raised its guidance for the rest of the year. The...
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InVivo adds 26th clinical site for spinal scaffold trial
InVivo Therapeutics (NSDQ:NVIV) said today it added a new site to the ongoing Inspire clinical study of its neuro-spinal scaffold designed to treat patients with complete thoracic AIS A spinal cord...
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FDA releases August 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD August 2016 TOTAL 510(k)s THIS PERIOD 252 TOTAL WITH SUMMARIES 235 TOTAL WITH STATEMENTS 17 DEVICE: CompleClear...
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Consumer expenditure on FDA regulated products: 20 cents of every dollar
By: Sheri Walker, Ph.D., and Clark Nardinell One of the much-cited statistics about FDA is this: that FDA-regulated products account for about 20 cents of every dollar of annual spending by U.S....
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Abbott looks to mollify EU regulators on St. Jude Medical merger; sues Alere...
Abbott (NYSE:ABT) made moves yesterday on a pair of pending, multi-billion-dollar acquisitions, its $25 billion merger with St. Jude Medical (NYSE:STJ) and a $6 billion union with Alere (NYSE:ALR). The...
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Mylan, Teva crash as DOJ could file charges by end of year
The U.S. Justice Dept. could reportedly file charges in its generic-drug pricing probe into companies including Mylan Pharmaceuticals (NSDQ:MYL) and Teva Pharmaceuticals (NYSE:TEVA) by the end of...
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Mast Therapeutics touts interim data from pulmonary hypertension study
Mast Therapeutics (NYSE:MSTX) touted interim data from a Phase II study of its AIR001 candidate in patients with pulmonary hypertension (PH) and PH associated with heart failure with preserved...
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Swiss researchers develop material that goes highly flexible to rigid
Researchers from Switzerland’s École Polytechnique Fédérale de Lausanne (EPFL) have developed a composite material made from silicone and copper alloy that can morph from being highly flexible to rigid...
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Navidea reels in losses, boosts sales in Q3
Shares in Navidea (NYSE:NAVB) rose yesterday after the company met expectations on Wall Street with its 3rd quarter results. The Dublin, Ohio-based company pared its losses by -99.3% to -$59,377 on...
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Study shows knee injuries change the brain
A new study shows that when you injure your knee, it changes your brain – which could put you at risk for further injuries. Using MRI, researchers at The Ohio State University Wexner Medical Center...
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Appeals court denies inventor in patent spat with Endologix pickup TriVascular
A federal appeals court yesterday upheld a lower court’s ruling on the claim construction in a patent infringement dispute between the inventor of a vascular stent patent and Endologix (NSDQ:ELGX)...
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FDA releases September 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD September 2016 TOTAL 510(k)s THIS PERIOD 257 TOTAL WITH SUMMARIES 250 TOTAL WITH STATEMENTS 7 DEVICE: BBX1, BBX2,...
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Baxter CEO Almeida on creating a bridge between invention and innovation
“The part that separates most companies regarding innovation, those that truly get it, is the bridge between the invention and the innovation,” Baxter chairman & CEO Joe Almeida said last week at...
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Boston Scientific extends $210 million tender offer for EndoChoice
Boston Scientific (NYSE:BSX) said today that it’s extending its $210 million tender offer for EndoChoice (NYSE:GI) and its line of devices for treating gastrointestinal disease. The $8-per-share tender...
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Antibacterial coated suture wins WHO recommendation
Ethicon said today that its triclosan-coated suture was included in the new “Global Guidelines for the Prevention of Surgical Site Infections (SSI)” by the World Health Organization. The guidelines are...
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Pulmatrix reports Q3 loss, revenue down 91%
Shares in Pulmatrix (NSDQ:PULM) rose slightly after the biotechnology company released its 3rd quarter results. The Lexington, Mass.-based company reeled in its losses 35% to $3.2 million compared to a...
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LVAD dev CorWave raises $17.1m in Series B
Circulatory support device developer CorWave said today it raised $17.1 million in a Series B round of financing to support its novel left ventricular assist device. The round was led by new investor...
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Regeneron boosts profits, misses revenue in Q3
Shares in Regeneron (NSDQ:REGN) gained today after the biopharmaceutical company crushed earnings expectations on Wall Street with its 3rd quarter results. The Tarrytown, New York-based company posted...
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