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Cardium takes another swing at FDA clearance for wound care product
Cardium hands federal regulators all necessary paperwork for a new 510(k) submission of its Excellagen wound care product.Cardium Therapeutics (NYSE:CXM) appealed to U.S. federal regulators for 510(k)...
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PFM Medical lands FDA approval for heart plug
California-based PFM Medical wins FDA approval for its Nit-Occlud implant, designed to non-surgically close a hole in the heart caused by a congenital heart defect.Cardiovascular device firm PFM...
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Texas spinal devices maker LDR Holding shoots for IPO of up to $69M
Austin, Texas-based LDR Holding is aiming for as much as $69 million with an initial public offering, the details of which are not yet hashed out.LDR Holding Corp. announced that it's making a bid for...
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HeartWare lands FDA OK to enroll another cohort in ongoing VAD study
HeartWare International plans to enroll a new arm of patients into its ongoing ENDURANCE clinical trial, this time confirming previous findings that suggest that more blood pressure management can help...
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AtriCure widens exclusive contract with Japanese distributor
AtriCure and Century Medical beef up their Japanese distribution contract for surgical ablation tools, extending exclusivity until 2019.AtriCure (NSDQ:ATRC) inked a bigger and bolder contract with its...
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Class action lawsuit accuses Biolase and officers of lying to investors
A group of Biolase shareholders are suing in a class action lawsuit accusing company directors of lying about its financial struggles.Biolase (NSDQ:BLTI) is facing a lawsuit brought by shareholders...
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Varian sells 20 new radiosurgery systems to U.K. healthcare regulators
The U.K.'s NHS Supply Chain orders 20 TrueBeam radiosurgery systems from Varian Medical Systems, doubling last year’s order.The British NHS Supply Chain bought 20 of Varian Medical Systems' (NYSE:VAR)...
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MassDevice.com +3 | The top 3 med-tech stories for August 29, 2013
If you read nothing else today, make sure you're still in the know with MassDevice +3.Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of...
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Lab-grown mini-brains help study neurological disease | MassDevice.com On Call
Austrian researchers have developed a human-stem-cell-based model of the developing brain, which may provide new avenues to develop treatments for neurological diseases that are difficult to...
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California spinal startup announces $3.6M IPO
Carlsbad-based Aurora Spine announces that it filed the final documents to proceed with an initial public offering worth up to $3.6 million.Carlsbad, Calif.-based Aurora Spine is hoping to round up as...
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Surgeons have a responsibility to be innovators
Vector is Children's Hospital Boston's blog about research and innovation in pediatric and adult medicine. We report and comment on medical innovations and advances – from bench to bedside – touching...
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FDA clears 3D-printed skull fillers by Tissue Regeneration Systems
Tissue Regeneration Systems wins FDA clearance for its Cranial Bone Void Filler, which the company calls the 1st 3D-printed skeletal reconstruction implant to get a green light in the U.S.Tissue...
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Boston Scientific's new skin implant is less of a shock to the heart
Boston Scientific’s under-the-skin implantable defibrillator proves a "viable alternative" to traditional implants that thread wires into the heart.News Well, Cardiac Implants, Cardiac Rhythm...
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FDA puts highest-risk label on Stryker's spinal device recall
Issues with Stryker's Oasys Midline Occipital Plate, already flagged for recall by Australian regulators, get the FDA's highest-risk recall.Updated August 30, 2013, at 4:00 p.m. with comments from...
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More legal trouble for Fresenius
Legal troubles escalate for German healthcare giant Fresenius, which now faces a class action lawsuit over its dialysis drug GranuFlo.Hundreds of lawsuits against Fresenius (NYSE:FMS) escalated into a...
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Mass. mHealth company raises $58k in 1 month, mostly during golf tournament
Mobile health company Health eVillages rakes in $58,000 in 1 month, most of money raised through its 1st annual golf tournament.Reading, Mass.-based mobile health company Health eVillages raised...
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FDA says yes to Zimmer's patient-specific shoulder implant system
The FDA green-lights Zimmer's Patient Specific Instruments Shoulder system, which helps surgeons create custom patient surgical guides and personalized treatment plans for reverse shoulder...
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Align Technology seeks cease-and-desist against ClearCorrect
The International Trade Commission reviews Align Technology's patent infringement case against ClearCorrect, including the company's cease-and-desist request.After a favorable ruling for Align...
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Lombard treats 1st U.S. patients with Aorfix flexible aortic stent graft
U.K.-based Lombard Medical treats its 1st U.S. patients with the Aorfix stent graft, which the company calls "the only endovascular stent graft with approved labeling for use in more challenging cases...
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Study: Presence of sales reps influences coronary stent selection, price
The presence of a sales rep can increase the per-case price of stenting by as much as $230, according to a study in the American Heart Journal.A sales rep's visit could be worth as much as $230 per...
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