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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FDA releases updated draft guidance on 510(k) modification submissions
The FDA today released draft guidance providing updated recommendations for manufacturers on when to submit 510(k) applications for modifications to devices currently on the market.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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AtriCure shares dip despite Street-beating Q2
AtriCure (NSDQ:ATRC) released 2nd quarter earnings late yesterday that topped the street in losses per share, but still saw shares dip in trading today. The Mason, Ohio-based company reported losses of...
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Mirabilis Medica brings in $5 million
Uterine fibroid-treating device developer Mirabilis Medica raised $5 million in a new round of debt financing, according to an SEC filing posted today. The company’s Mirabilis system is designed to...
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Smith & Nephew closes $350m Truclear sale to Medtronic, launches $300m buyback
Smith & Nephew (NYSE:SNN) said today that it closed the $350 million sale of its gynecology business, including the Truclear hysteroscopy system, to Medtronic (NYSE:MDT). The London-based...
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ANVISA officially extends deadline for IVD and cadastro technical dossier...
By Stewart Eisenhart, Emergo Group Brazil’s medical device regulator ANVISA has announced official extensions for deadlines to file technical dossiers for low-risk cadastro medical devices as well as...
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Sunshine Heart pays $5m for Baxter’s Aquadex
Sunshine Heart (NSDQ:SSH) said today that it agreed to pay about $5 million for the Aquadex fluid filtration device Baxter (NYSE:BAX) acquired when it bought Gambro in 2013. The Aquadex device is...
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Medtronic wins CE Mark for SureTune2 DBS software
Medtronic (NYSE:MDT) said today that it won CE Mark approval in the European Union for the SureTune2 software used with its deep-brain stimulation devices. The software is designed to allow physicians...
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Alere ticks up after reporting delayed 2015 results
Shares in Alere (NYSE:ALR) ticked up today after the diagnostics giant reported its long-delayed financial results ahead of its $6 billion union with Abbott (NYSE:ABT). Alere, which last month cut its...
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