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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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MassDevice.com +3 | The top 3 medtech stories for March 3, 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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Xtant Medical wins CE Marks for Aranax, Irix-A spine devices
Xtant Medical said today it won CE Mark approval in the European Union for its Aranax cervical plating system and and Irix-A stand alone anterior lumbar fusion device. The company’s Aranax cervical...
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Fujifilm, Canon lead the running in $6B race for Toshiba Medical
Fujifilm Holdings (TSE:4901) and Canon (NYSE:CAJ) are at the head of the crowd looking to pick up Toshiba‘s (TYO:6502) medical device business, according to The Wall Street Journal, at a price...
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Stryker reups PGA Tour deal
Stryker (NYSE:SYK) said today it extended its relationship with the PGA Tour as the “Official Joint Replacement Products” of the PGA through the 2016 season, expanding its presence at both the PGA Tour...
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FDA expands Draeger ventilator recall, includes power supply batteries
The FDA today said it expanded its recall of Draeger Medical‘s Evita V500 and Babylog VN500 ventilators to include the optional PS500 batteries after they were updated with new power supply firmware...
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Embracing the cloud
As I have written about previously, CIOs across the country are telling me that expectations for IT delivery are at an all time high. More must be delivered faster, cheaper, and with greater...
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Boston Scientific loses appeal in $14m loss to cutting balloon inventor
A federal appeals court yesterday refused to reconsider its decision awarding $14 million to the inventor of a cutting balloon catheter, Dr. Banning Lary, for royalties owed by Boston Scientific...
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DT Medtech acquires Hintermann foot & ankle assets
DT MedTech said it acquired the Hintermann lower extremities assets for an undisclosed amount, including the H3 total ankle replacement and revision system and the Kalix II implant designed to treat...
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FDA clears Stryker’s Tritanium PL lumbar cage
Stryker (NYSE:SYK) said today that it won 510(k) clearance from the FDA for its Tritanium PL posterior lumbar cage for lumbar spinal fixation. The Kalamazoo, Mich.-based orthopedics giant said it’s...
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Mindray Medical closes $3B go-private deal
Mindray Medical said yesterday that it closed the $3.3 billion go-private deal the Chinese medical device company inked with its managers. The $28-per-share deal means MR shares have ceased trading on...
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