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Si-Bone launches iFuse warranty program

Si-Bone said today it launched an iFuse warranty program which will supply patients with a free iFuse Implant to supplement or replace previously placed iFuse implants within a year if revision surgery...

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Fresenius expands CytoSorbents deal

CytoSorbents Corp. (NSDQ:CTSO) and Fresenius Medical Care (NYSE:FMS) said today that the 2 companies have expanded the terms of their partnership and added a co-marketing agreement for the CytoSorb...

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FDA’s CDRH reveals guidance plans for FY2017

Heather Thompson, MDO senior editor CDRH is setting its goals along with the rest of us for the new year. The agency has published and prioritized its intentions for FY2017, starting with a list of new...

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NuVasive Q4, FY2016 prelims beat estimates

NuVasive Inc. (NSDQ:NUVA) today released preliminary full year 2016 and 4th quarter earnings, with posted revenue topping estimates from The Street and sending shares upwards. The company said it...

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Medicrea submits 510(k) app for 3D-printed spinal interbody device

Medicrea (EPA:ALMED) said today it filed a 510(k) submission to the FDA seeking approval of its 3D-printed titanium interbody devices. The New York City and Lyon, France-based company’s 3D-printed...

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Titan Spine reels in $1.5m

Titan Spine has raised $1.5 million in a new round of equity financing, according to an SEC filing posted this week. Money in the round came from 9 anonymous investors, according to an SEC filing, and...

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Ivantis raises $25m in Series C to support Hydrus microstent

Ivantis said today it raised $25 million in a Series C round of financing to support its Hydrus microstent device designed for treating glaucoma. The round was led by newly invested RA Capital...

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UnitedHealth to buy Surgical Care Affiliates for $2.3B

(Reuters) – UnitedHealth Group Inc‘s said it would buy Surgical Care Affiliates Inc for about $2.30 billion, adding heft to its business that provides services including primary and urgent care in...

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Japanese regulators to reduce some QMS assessment fees 30% in 2017

By Stewart Eisenhart, Emergo Group Japanese medical device market regulators plan to reduce conformity assessment fees for certain device quality management systems by 30% in April 2017. Get the full...

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Study shows Alzheimer’s drug activates stem cells in teeth

Researchers from King’s College London have shown that an Alzheimer’s drug can stimulate the stem cells found in tooth pulp and generate a protective material, dentine, in large cavities. The team’s...

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Hill-Rom to pay $330m for Mortara Instrument

Hill-Rom (NYSE:HRC) said today that it agreed to put up $300 million for Mortara Instrument and its line of diagnostic cardiology and patient monitoring devices, not including a $40 million “tax...

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Lessons Learned Building Acclarent from Scratch: Interview with Bill Facteau,...

Bill Facteau, President and CEO of Earlens Welcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group...

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Claret Medical wins a date with the FDA for Sentinel TAVR device

An FDA advisory panel is slated to review next month the Sentinel embolic protection device made by Claret Medical, following the company’s bid for de novo clearance last fall. The federal watchdog’s...

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Intersect ENT shares jump on Q4 prelims

Intersect ENT (NSDQ:XENT) shares jumped yesterday 11% to reach a peak of $13.20 apiece after the company released its preliminary financial results for the 4th quarter, narrowly beating analysts’...

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DexCom gains on Q4 prelims

DexCom Inc. (NSDQ:DXCM) posted its preliminary financial results for the 4th quarter, meeting analysts’ expectations on Wall Street and sending its shares upwards. The San Diego, Calif.-based company...

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Neurosurgeon gets 20 years in unneeded spinal surgery fraud scheme

A neurosurgeon in Michigan this week was sentenced to nearly 20 years in prison after pleading guilty to a $2.8 million health care fraud scheme in which he performed unnecessary invasive spinal...

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Boston Scientific finds ‘fix’ for Lotus Edge heart valve, preps for May PMA...

Boston Scientific (NYSE:BSX) has reportedly found a fix for its Lotus Edge heart valve after the company paused implantations of the device in October last year. The Marlborough, Mass.-based company...

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CytoSorbents shares lift on Q4 prelims

CytoSorbents Corp. (NSDQ:CTSO) posted its preliminary financial results for the 4th quarter, meeting analysts’ expectations on Wall Street. The Monmouth Junction, N.C.-based company said it expects a...

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MassDevice.com +5 | The top 5 medtech stories for January 10, 2017

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s...

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Medtronic updates 2017 guidance

Medtronic (NYSE:MDT) today saw shares rise slightly as it released updates to its full year and 2nd half 2017 guidance, staying mostly in line with previous guidance. The Fridley, Minn.-based company...

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