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NuVasive wins CMS add-on payment for Magec growth mod system
NuVasive Inc. (NSDQ:NUVA) said today the Centers for Medicare and Medicaid Services granted a new technology add-on payment for magnetically controlled growth rods, including the company’s Magec...
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Siemens lifts profit forecast, adapts to low-growth world
(Reuters) – German industrial group Siemens (NYSE:SI) raised its full-year earnings forecast for the 2nd time this year after large energy projects helped to take its 3rd-quarter results above...
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EndoChoice wins FDA 510(k) for Lumos imaging software
EndoChoice said today it won FDA 510(k) clearance for its Lumos imaging software system, part of the company’s 3 Fuse Full Spectrum Endoscopy system, and launched the system in the U.S. The Lumos...
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Osprey Medical raises $21.3m
Osprey Medical (ASX:OSP) said it raised $21.3 million (AUD $28 million) through the sale of CHESS depository interests to support the expanded commercialization of its DyVert System and ongoing...
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Masimo wins CE Mark for O3 pediatric indication
Masimo (NSDQ:MASI) said today it won CE Mark approval for a pediatric indication on its O3 regional oximetry with the O3 pediatric sensor. The O3 regional oxymetry system uses near-infared spectroscopy...
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MassDevice.com +5 | The top 5 medtech stories for August 4, 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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Cardiovascular Systems Q4 numbers top estimates, releases Q1 2017 guidance
Cardiovascular Systems (NSDQ:CSII) today released 4th quarter and full year 2016 results, topping the Street’s estimates and releasing its 1st quarter outlook. Cardiovascular Systems reported losses of...
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Hill-Rom posts Q3 earnings beat, raises outlook
Hill-Rom Holdings (NYSE:HRC) shares are up slightly today after the company reported higher-than-expected earnings for the 3rd quarter, lifting its outlook for the 4th and full fiscal year. The...
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NeMaura meets with FDA, plans for regulatory submission
Diabetes-focused device developer NeMaura Medical said today it met with the FDA to discuss the clinical programs necessary for pursuing premarket approval submission for its sugarBEAT minimally...
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Haemonetics taps ex-Medtronic CIO Burke as new CFO | Personnel Moves August...
Haemonetics taps ex-Medtronic CIO Burke as new CFO Haemonetics (NYSE:HAE) said this week it tapped former Medtronic (NYSE:MDT) chief integration officer William Burke as its new chief financial...
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Title 21: 1981
When you visit IMARC Research’s office, you will notice beautiful artwork on our lobby wall. The artwork pays homage to key events in the history of clinical research. We also released an eBook that...
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Check-Cap partners with GE to dev indigestible X-ray screening capsule
Check-Cap (NSDQ:CHEK) said yesterday it inked a development and manufacturing validation deal with GE Healthcare (NYSE:GE) for integrating X-ray source production and assembly into Check-Cap’s...
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TransEnterix sees light on Q2 release, shares tick up
TransEnterix (NYSE:TRXC) hasn’t had the best luck in 2016, with the FDA denying its 510(k) clearance submission in April and shareholders suing the company in June over the nixed project, but things...
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Johnson & Johnson wins 5-year, $60m supply DoD contract
Johnson & Johnson (NYSE:JNJ)’s Health Care Systems won a $60 million 5-year contract deal with the U.S. Department of Defense to supply dental and medical equipment. The money comes from a...
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FDA releases updated draft guidance on 510(k) modification submissions
The FDA today released draft guidance providing updated recommendations for manufacturers on when to submit 510(k) applications for modifications to devices currently on the market. The recommendations...
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Viveve lands S. Korea regulatory clearance for Viveve System
Viveve (NSDQ:VIVE) said today it won regulatory approval from the Ministry of Food and Drug Safety in South Korea for its Viveve non-surgical treatment for post-partum laxity of the vaginal introitus....
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Endologix releases Q2, updates on Nellix discussions with FDA
Endologix (NSDQ:ELGX) on Wednesday released 2nd quarter earnings and updated on its discussions with the FDA over its Nellix system for treating abdominal aortic aneurysms, saying the agency is...
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Draeger recalls VentStar Oxylog 3000 pediatric breathing circuits
The FDA today released information on a Class I recall of Draeger Medical‘s VentStar Oxylog 3000 disposable pediatric patient circuits over issues with air leakage. The federal watchdog labeled the...
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InVivo Therapeutics Q2 meets the street, shares stay steady
InVivo Therapeutics (NSDQ:NVIV) shares stayed steady after the company released 2nd quarter earnings that met the street on losses per share. The Cambridge, Mass.-based company reported losses of $5.2...
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MassDevice.com +5 | The top 5 medtech stories for August 5, 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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