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FDA accepts HDE submission from InVivo for Neuro-Spinal scaffold
InVivo Therapeutics (NSDQ:NVIV) said today that the FDA accepted its proposed Humanitarian Device Exemption modular shell submission and review process for its Neuro-Spinal Scaffold. The modular HDE...
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Uptake Medical touts InterVapor study results indicating improved lung function
Uptake Medical said today that data from a study recently published in the journal Lancet indicated that patients who underwent therapy using the company’s InterVapor system experienced statistically...
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Philips debuts Intellispace intensive care support system
Royal Philips (NYSE:PHG) said today it launched its IntelliSpace Console Critical Care cloud-based clinical decision support dashboard designed to support enhanced workflows intensive care units. The...
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Smith & Nephew release 3D printed titanium hip implant
Smith & Nephew (NYSE:SNN) today launched its fully 3D-printed titanium Redapt revision acetabular fully porous cup with Conceloc technology. The device was released at the American Academy of...
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MassDevice.com +3 | The top 3 medtech stories for March 1, 2016
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the...
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Diabetes: J&J’s LifeScan inks collab deal with WellDoc
Johnson & Johnson (NYSE:JNJ) subsidiary LifeScan said today it inked a strategic collaboration deal with WellDoc Corporation and joined in a Series B round of financing for the company, with goals...
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Masimo launches Iris Gateway medical device data integration software
Masimo (NSDQ:MASI) said today it launched the Iris Gateway server-based medical device data integration software. The release was announced at the Healthcare Information and Management Systems...
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Not up on the US medical device market? Here’s what’s happened in 2016 so far
By Stewart Eisenhart, Emergo Group US regulators have warranted close attention from the QA/RA Blog since 2016 began. Using new 510(k) performance data from the FDA, Emergo has conducted an updated...
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ConforMIS sues Smith & Nephew, launches iTotal PS knee implant
ConforMIS (NSDQ:CFMS) leveled a lawsuit against Smith & Nephew (NYSE:SNN) this week, accusing the British orthopedics giant of trespassing on 8 patents covering the ConforMIS technology for...
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Olympus to pay nearly $650m to settle kickbacks charges
A U.S. subsidiary of Olympus (TYO:7733) agreed to pony up $623.2 million to resolve criminal and civil charges that it paid kickbacks to doctors and hospitals for using its medical imaging equipment,...
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Retina Implant drums up $28m
Retina Implant said this week that it raised $28.2 million (€26 million) in private equity funding for its Alpha IMS device, which is designed to treat blind patients with retinitis pigmentosa. The...
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FDA approves Edwards Lifesciencies Sapien XT for pulmonary valve procedures
Edwards Lifesciences (NYSE:EW) said today that it won FDA approval for the use of its Sapien XT replacement heart valve in adult and pediatric patients with conditions affecting their pulmonary valves....
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FDA warns ReWalk on lack of post-market surveillance for exoskeleton
The FDA today released a warning letter it sent to ReWalk Robotics (NSDQ:RWLK), formerly Argo Medical, over a failure to submit a post-market surveillance report on its ReWalk exoskeleton device...
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Johnson & Johnson launches JLABS incubator in Houston
Johnson & Johnson (NYSE:JNJ) said today it launched JLABS life science incubator in Houston, designed to provide shared lab space, offices and laboratory suites and equipment for up to 50 startups....
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Zimmer Biomet buys Ortho Transmission’s direct-to-skeleton prosthetic...
Zimmer Biomet (NYSE:ZBH) said yesterday that it acquired Ortho Transmission and its transcutaneous osseous integrated skeletal implant technology for an undisclosed amount. The buyout dovetails with...
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InVivo adds Greenville, N.C. site to Inspire neuro-spinal scaffold study
InVivo Therapeutics (NSDQ:NVIV) said today it added a clinical site at the Vidant Medical Center in Greenville, N.C.to its Inspire study examining the probable benefit of its Neuro-Spinal Scaffold,...
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Nevro promotes prez Elghandour to replace CEO DeMane | Personnel Moves
Nevro Corp. (NYSE:NVRO) this week promoted president Rami Elghandour to be its new CEO, as chief executive Michael DeMane moves to the executive chairman spot. DeMane, the former COO at Medtronic, will...
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Cantel Medical closes $13.5m buy of NAMSA’s sterility assurance biz
Cantel Medical (NYSE:CMN) said today it closed its $13.5 million buy of North American Science Associates sterility assurance business, which Cantel said it plans to fold into its Crosstex division....
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MassDevice.com +3 | The top 3 medtech stories for March 2, 2016
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the...
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AOSS roundup: JNJ inks deal for bundled payments for hip & knee replacements
Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes today announced an exclusive strategic alliance with Value Stream Partners, a company specializing in knee and hip replacement bundled payment...
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