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Intuitive Surgical reports Street-beating Q1, shares lift 15% in after hours
Industry-leading robotic surgery company Intuitive Surgical (NSDQ:ISRG) released its 1st quarter 2016 earnings today, seeing significant gains over last year’s Q1 but a little behind its 2015 Q4. The...
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Ortho Kinematics wins CE Mark for spinal motion analyzer
Ortho Kinematics said today it won CE Mark approval in the European Union for its Vertebral Motion Analysis system designed to assess spinal motion and radiographic instability. The VMA system from...
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What we mean when we talk about EvGen part I: Laying the foundation for a...
By: Rachel E. Sherman, M.D., M.P.H., and Robert M. Califf, M.D. Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current paradigm of generating the...
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Internet petition wants Congress to oust CDRH head Shuren
A group of upset citizens are petitioning for the removal of FDA Center for Devices and Radiological Health head Dr. Jeffrey Shuren, stating dissatisfaction with the control of devices such as Bayer‘s...
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St. Jude posts street-beating Q1
Updated with guidance information for Q2 and full year 2016. St. Jude Medical (NYSE:STJ) released 1st quarter 2016 results that beat the Street, despite seeing profits slip from the same quarter last...
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Robotic surgery mix-up: Moll’s Auris buys Hansen Medical
Stealthy robotics-company Auris Surgical Robotics is mixing up the robotic surgery game, saying today it signed a deal to pick up Hansen Medical (NSDQ:HNSN) for approximately $80 million. Through the...
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Boston Scientific wins CE Mark for MR-safe Emblem S-ICDs
Boston Scientific (NYSE:BSX) said today it won CE Mark approval for its Emblem MRI subcutaneous implantable defibrillator system and magnetic resonance conditional labeling for all previously implanted...
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Abbott raises guidance as its 2016 Q1 earnings squeak by the street
Abbott Laboratories (NYSE:ABT) upped its full-year earnings forecast and saw shares stay stable after releasing 1st quarter 2016 earnings that just slipped past the Street’s estimates Abbott reported...
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Bone Biologics closes $5.8m round
Regenerative orthobiologic company Bone Biologics said it recently closed a $5.75 million round joined by the Musculoskeletal Transplant Foundation, Orthofix (NSDQ:OFIX) and Hankey Capital to support...
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Medtronic initiates voluntary recall of Covidien Oridion Capnostream batteries
Medtronic (NYSE:MDT) said today it is initiating a voluntary recall of battery packs used with its Covidien Oridion labeled Capnostream 20 and 20p patient monitors due to a defect causing an increased...
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Alere shares sink after Abbott CEO fuels speculation deal at risk
(Reuters) – Abbott‘s (NYSE:ABT) chief executive said on Wednesday it would not be appropriate to comment on whether the company was committed to buying diagnostics company Alere (NYSE:ALR), fueling...
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Invo Bioscience launches InvoCell in US
INVO Bioscience said today it launched its InvoCell intravaginal culture infertility treatment system in the U.S., starting in Texas through the Center for Assisted Reproduction. INVOcell is designed...
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Bovie Medical launches J-Plasma Precise 360
Bovie Medical (NYSE:BVX) said today it launched its J-Plasma compatible Precise 360 hand piece designed for prostate surgery procedures. The newly released J-Plasma Precise 360 handpiece is designed...
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Study: Medtronic touts increased AF detection with Reveal Linq system
Medtronic (NYSE:MDT) today released 1-year results from a study of patients who experienced a cryptogenic stroke, claiming that its Reveal Linq insertable cardiac monitor was able to detect atrial...
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MassDevice.com +5 | The top 5 medtech stories for April 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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Strengthening partnerships: FDA’s China office engages in key outreach with...
By: S. Leigh Verbois, Ph.D. 独木不成林,单弦不成音 Dú mù bù chéng lín, dān xián bù chéng yīn ‘A single tree makes no forest, one string makes no music.’ “A single tree makes no forest, one string makes no music.”...
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FDA: TransEnterix Surgibot 510(k) does not meet criteria for “substantial...
Updated to include share prices TransEnterix (NYSE:TRXC) said today that the FDA responded to the 510(k) application for its robotic surgery SurgiBot system, saying that the platform does not meet the...
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Stryker closes CareFusion vertebral compression buy, releases street-beating Q1
Stryker (NYSE:SYK) said today it closed its buy of CareFusion‘s vertebral compression fracture portfolio from Becton Dickinson & Co. (NYSE:BDX) in an all-cash transaction and released a...
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Cartiva wins nod from FDA panel for its synthetic cartilage implant
Cartiva said today that the FDA’s Orthopaedic and Rehabilitation Devices Panel voted in favor of the company’s synthetic cartilage implant for treating osteoarthritis at the base of the big toe. The...
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Hologic wins FDA nod for Affirm biopsy system, launches in US
Hologic (NSDQ:HOLX) said today it won FDA 510(k) clearance for its Affirm prone biopsy system and launched the platform in the U.S. The Affirm biopsy system is the 1st prone biopsy system to offer both...
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