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Cheetah Medical inks supply deal with Allina Health
Cheetah Medical said today it inked a supplier contract with non-for-profit healthcare system Allina Health. Through the contract, Minnesota and western Wisconsin based Allina Health will gain access...
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MassDevice.com +5 | The top 5 medtech stories for July 19, 2016
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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Intuitive Surgical jumps on Q2 beats
Intuitive Surgical (NSDQ:ISRG) shares jumped in after-hours trading yesterday as investors reacted to 2nd-quarter numbers that handily topped expectations on Wall Street. The robot-assisted surgery...
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Addressing global challenges through transatlantic cooperation | FDAVoice blog
By: Howard Sklamberg, J.D., Lou Valdez, and Donald Prater Reflecting the broad scope of our transatlantic dialogue, we engaged on an array of issues, including supply chain safety, quality metrics,...
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Boston Scientific to settle IRS beef for $275m
Boston Scientific (NYSE:BSX) said it agreed yesterday to pay the U.S. Internal Revenue Service $275 million plus interest to settle a tax beef dating back to its $26 billion acquisition of Guidant in...
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St. Jude Medical ticks up on Q2 sales beat
St. Jude Medical (NYSE:STJ) shares are up today after the medical device company reported higher-than-expected sales for the 2nd quarter and met Wall Street’s consensus earnings forecast. Little...
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Abbott rises on Q2 earnings, sales beats
Abbott (NYSE:ABT) saw its stock rise today after reporting earnings and sales that came in above the consensus outlook on Wall Street. The Abbott Park, Ill.-based healthcare giant posted profits of...
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US medical device market path defined in 10 key terms
By Debra Grodt, Director of Regulatory Affairs, Medical Device & Diagnostics, Novella Clinical What is a regulatory assessment? A regulatory assessment is a comprehensive review of Food & Drug...
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Medtronic wins 1st FDA nod for cement-augmented spine screws
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its CD Horizon fenestrated cement-augmented spinal pedicle screw set, designed to be used with Medtronic’s HV-R polymethylmethacrylate...
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FDA warns Oscor on process control records
The FDA last month warned contract manufacturer Oscor on its methods for documenting process controls for the catheters and neurostimulation leads it makes, after inspections in February and March...
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FDA readies panel on diabetes dosing label for Dexcom’s G5 CGM
The FDA yesterday released information on a panel its holding over Dexcom Inc.‘s (NSDQ:DXCM) G5 continuous glucose monitor, as the company seeks an expanded indication. The new indication would allow...
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Your inhaler’s watching you: drugmakers race for smart devices
(Reuters) – Makers of inhalers to treat asthma and chronic lung disease are racing to develop a new generation of smart devices with sensors to monitor if patients are using their puffers properly....
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MassDevice.com +5 | The top 5 medtech stories for July 20, 2016
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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TE Connectivity gains on Q3 earnings beat
TE Connectivity (NYSE:TEL) shares are up today after the contract manufacturing giant beat expectations with its fiscal third-quarter earnings and said it would acquire German connector maker...
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Reflexion adds $6m to bring Series B to $52m
California-based medtech group RefleXion Medical said yesterday it extended its Series B round of financing, bringing in an extra $6 million to bring the total for the round up to $52 million....
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Philips acquires population health mgmt co. Wellcentive
Royal Philips (NYSE:PHG) said today it inked a deal to pick up population health management software dev Wellcentive for an undisclosed amount. Philips said the purchase would “compliment” its current...
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Ex-Acclarent CEO, sales VP convicted in criminal case
A federal jury today convicted 2 former Acclarent executives, for the distribution of adulterated and misbranded medical devices. Former CEO William Facteau and ex-sales vice president Patrick Fabian...
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Xtant Medical ticks up on Q2 prelims
Xtant Medical saw shares tick up approximately 2% after releasing preliminary revenue figures for its 2nd quarter that saw and EBITDA up from its 1st quarter. The company said it expects to report...
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Bristol-Myers Squibb launches Orencia ClickJect drug-device combo for...
Bristol-Myers Squibb said today it launched the Orencia ClickJect autoinjector designed for the self-administration of Orencia to treat moderate to severe rheumatoid arthritis. The Orencia ClickJect is...
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Printing your skull: How 3D printing helps surgeons plan complex...
At five months’ gestation, Bentley Yoder was given little chance to live. A routine 20-week “gender reveal” ultrasound showed that a large portion of his brain was growing outside of his skull, a...
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