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Intuitive Surgical: Q4, FY2015 earnings trounce street; New FDA 510(k)

Intuitive Surgical (NSDQ:ISRG) released a bevy of good news today, posting Q4 and fiscal year 2014 earnings that trounced street estimates and announcing FDA 510(k) clearance for the Integrated Table...

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Centinel Spine wins FDA 510(k) for Altos cervical spine implant

Centinel Spine said today it won FDA 510(k) clearance for its Altos posterior cervical thoracic stabilization system with indications for use in lateral masses of the cervical spine or pedicles of the...

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Medtech approvals: FDA releases November 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in November 2015: Summary of PMA Originals & Supplements Approved Originals: 3 Supplements: 69 Summary of...

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MTD Micro Molding adds ultrasonic molding capability

MTD Micro Molding has added ultrasonic molding capability to the molding services menu with the purchase of an Ultrasion molding machine. MTD has invested in an ultrasonic molding machine, which takes...

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Advancing women’s health research

By: Pamela E. Scott, Ph.D. Career inspiration can come from many sources. My inspiration came from a broken ankle. In the winter of 1999, I broke several bones and had three surgeries to repair my...

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C.R. Bard closes $181m Liberator Medical buy

C.R. Bard (NYSE:BCR) said yesterday that it closed the $181 million acquisition of Liberator Medical (NYSE:LBMH), a direct-to-consumer distributor of durable medical equipment. The deal called for...

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UPDATE: Philips forced to spike Lumileds deal on U.S. security concerns

Updated with new information on the proposed sale. (Reuters) — Royal Philips‘s (NYSE:PHG) plan to shed its lighting businesses suffered a setback on Friday when a $3.3 billion deal to offload the...

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InspireMD CEO Milinazzo, CTO Bar to bow out | Personnel Moves

InspireMD (OTC:NSPR) said today that it’s looking for a replacement for CEO Alan Milinazzo as it looks to drill down on the largest markets for its CGuard and MGuard stents, which are designed to help...

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Sales and profits slide for GE Healthcare

General Electric (NYSE:GE) said today that sales and profits in its GE Healthcare division slid for both the 4th quarter and full-year 2015, as the industrial conglomerate’s overall sales missed...

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Intuitive Surgical CEO Guthart unfazed by upcoming competition

Gary Guthart, the longtime CEO of robot-assisted surgery pioneer Intuitive Surgical (NSDQ:ISRG), said yesterday that he’s confident Intuitive will be able to compete as smaller rivals begin hitting the...

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FDA proposes to require PMAs for cranial electrotherapy stimulators for...

The FDA is proposing to require manufacturers of cranial electrotherapy stimulators to submit pre-market approval applications if their devices are intended to treat depression. The federal safety...

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Cardiovascular Systems tumbles on Q2 misses

Cardiovascular Systems shares plummeted after releasing significant misses for its FY2016 Q2 earnings, dropping over 30% in mid-day trading. St. Paul, Minn.-based Cardiovascular Systems reported...

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K2M wins CE Mark for Rhine cervical disc

K2M (NSDQ:KTWO) said yesterday it won CE Mark approval in the European Union for its Rhine cervical disc system designed to treat degenerative disc disease. The Leesburg, Va.-based company said the...

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Advanced Medical Isotope hires IR firm Circadian Group

Advaned Medical Isotope Corp said Wednesday it hired medical device, pharma and biotech-focused investor relations firm Circadian Group. Newly-retained Circadian group will focus on presenting AMIC’s...

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MassDevice.com +3 | The top 3 medtech stories for January 22, 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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FDA clears next-gen Pelvalon incontinence device

Pelvalon said yesterday it won FDA 510(k) for its next-generation Eclipse incontinence device designed for women suffering loss of bowel control. Sunnyvale, Calif.-based Pelvalon’s Eclipse is designed...

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ResMed jumps on Q2 earnings beat

ResMed (NYSE:RMD) saw shares jump after releasing Q2 earnings that topped the street in revenue and earnings. The San Diego, Calif.-based reported profits of $90.5 million, or 65¢ per share, on sales...

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Vascular Solutions droops on Q4, FY2015 earnings

Vascular Solutions (NSDQ:VASC) shares drooped over 10% after releasing a mixed bag of Q4 and its 2015 fiscal year earnings, beating the street for quarterly EPS and revenue, but missing for FY2015....

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Mercator MedSystems launches dual-therapy BTK Bullfrog device trial

Mercator MedSystems said yesterday it enrolled the 1st patient in its Limbo-PTA clinical trial aiming to examine the use of the company’s Bullfrog micro-infusion device delivering anti-inflammatory...

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FDA: St. Jude Medical’s Optisure recall is Class I

The FDA termed a recall by St. Jude Medical (NYSE:STJ) of a small number of its Optisure defibrillator leads as Class I, denoting the risk of serious injury or death. Little Canada, Minn.-based St....

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