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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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Recent US FDA regulatory updates you should know about

By Stewart Eisenhart, Emergo Group The US FDA has been busy since late 2015, issuing several new and updated guidance documents related to Human Factors, eCopy submissions, oversight of lab developed...

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Virtual Incision’s inside-the-body surgical robot logs 1st-in-human use

Virtual Incision this week announced the 1st-in-human use of its miniaturized robotically assisted surgical device, which was used in a colon resection procedures in Paraguay. The RASD is designed to...

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FDA approves Medtronic’s Specify SureScan MRI-safe neurostim leads

Medtronic (NYSE:MDT) said today that the FDA approved its MRI-safe Specify SureScan spinal cord stimulation leads for treating chronic pain. The Fridley, Minn.-based medtech titan said the approval...

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Sunshine Heart halts trial, ousts CEO Rosa

Sunshine Heart (NSDQ:SSH) said today that it replace CEO David Rosa with John Erb and halted a pair of clinical trials of its C-Pulse heart failure device. The C-Pulse system is designed to use...

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Gore wins FDA nod for Excluder stent graft

W.L. Gore & Assoc. said today that it won FDA approval for its Excluder stent graft for treating abdominal aortic aneurisms. The Excluder device is designed to treat aneurysms in the iliac arteries...

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Johnson & Johnson unit inks spine implant development deal with Rainbow Medical

Rainbow Medical said today that it inked a deal with a unit of Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes to co-develop a minimally invasive implant to treat degenerative disc disease....

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FDA clears Zimmer Biomet’s elbow-shoulder combo

Zimmer Biomet (NYSE:ZBH) said today that the FDA cleared the combination of its Nexel total elbow system and the Comprehensive segmental revision system, which the company said was its 1st clearance...

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Novocure wins reimbursement from Humana for Optune brain cancer device

NovoCure (NSDQ:NVCR) said today it won reimbursement from Humana for treatments with its Optune device for patients with recurrent glioblastoma. The Optune is a mobile device that delivers...

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InVivo continues the roll, adds another site to Inspire study

InVivo Therapeutics (NSDQ:NVIV) is continuing its momentum, saying today it added another clinical site, this time at the University of Louisville Hospital in Ky., to the Inspire trial testing its...

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Boston Scientific releases ureteral stent tracker app

Boston Scientific (NYSE:BSX) has launched a new app designed to help urologists track ureteral stents implanted in patients with kidney stones. The app was developed as a joint operation between the...

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