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St. Jude Medical wins CE Mark for full-body MRI scans with Proclaim Elite SCS...
St. Jude Medical (NYSE:STJ) said today that it won CE Mark approval in the European Union for full-body MRI scans of patients implanted with its Proclaim Elite spinal cord stimulation device. Little...
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PellePharm announces launch to develop topical gel for basal cell carcinoma
PellePharm announced its launch today, with financing from BridgeBio Pharma. The Menlo Park, Calif.-based company is developing a topical gel to treat basal cell carcinoma, including the tumors that...
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BioDelivery reacquires license to buprenorphine film
BioDelivery Sciences International (NSDQ:BDSI) said today that it reacquired the license to the Belbuca (buprenorphine) buccal film from Endo Pharmaceuticals. Malvern, Penn-based Endo Pharmaceuticals...
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Edwards shares rise on 2017 outlook
Edwards Lifesciences (NYSE:EW) shares have risen today in response to the company posting a positive outlook for 2017, despite 4th quarter numbers sliding towards the lower end of its guidance. The...
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Henry Schein buys 80% stake in Polish dental distributor Marrodent
Henry Schein (NSDQ:HSIC) said today made an 80% equity investment in Polish full-service dental distributor Marrodent. Warsaw, Poland-based Marrodent was founded in 1990, and recorded 2015 sales of...
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MassDevice.com +5 | The top 5 medtech stories for December 8, 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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Verily launches Liftware smart utensils
Verily Life Sciences, the healthcare play owned by Google parent Alphabet (NSDQ:GOOGL), said this week it launched the Liftware Level smart utensil designed to aid individuals with limited hand or arm...
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Augmedix announces partnership with Aryaka
Medical Google Glass startup Augmedix said recently it partnered with Aryaka to use its global SD-WAN technologies to provide reliable and fast network connectivity for its smartglass platform....
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How the 21st Century Cures Act will affect medical devices
The U.S. Senate overwhelmingly passed the 21st Century Cures Act yesterday, after the U.S. House voted to enact the healthcare measure last week. The bill will move to President Barack Obama’s desk and...
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Gordian Surgical wins FDA clearance, raises $2m for TroClose1200
Trendlines Medical portfolio company Gordian Surgical said this week it won FDA clearance for its TroClose 1200, along with announcing the closure of a $2.3 million funding round. The Israel-based...
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21st Century Cures Act: Impacts on the US medical device market
By Stewart Eisenhart, Emergo Group As legislation targeting a broad swath of US healthcare regulations awaits President Barack Obama’s signature after passage in the US Congress, effects of the pending...
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Zimmer Biomet, U.S. Justice Dept. near deal on bribery charges
The U.S. Justice Dept. and Zimmer Biomet (NYSE:ZBH) are close to reaching a deal to settle bribery allegations against the orthopedic device giant, according to federal prosecutors. The DoJ alleged...
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Sirtex slides on lowered profit outlook
Sirtex Medical (ASX:SRX) shares closed down more than -37% today after the Australian medical device company lowered its profit outlook for the rest of the year. Sydney-based Sirtex said it expects...
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H&T Presspart, Cohero Health launch connected metered-dose inhaler
H&T Presspart and Cohero Health said today that the companies have launched a connected metered-dose inhaler designed to improve adherence and optimize care for patients with asthma and COPD. It is...
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Medtech approvals: FDA releases November 2016 PMA approvals
Summary of PMA Originals & Supplements Approved Originals: 1 Supplements: 114 Submission Number Date Final Decision Review Track Trade Name Appl/Spr Name Approval Order Statement P150043...
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CMS pinpoints cost-driving drugs in newly released data
Centers for Medicare & Medicaid Services released 5 years of pricing data for a list of more than 5,000 drugs this week. The data illustrate that a handful of cost-driving drugs experienced price...
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Potential Trump pick for FDA chief has no medical experience, prompting concerns
President-elect Donald Trump is reportedly considering Jim O’Neill, a libertarian and Silicon Valley investor with no medical experience, as head of the FDA and that has some healthcare experts...
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Medical device tax likely to get the axe under Trump admin
The medical device tax is likely to quickly be on the chopping block under the incoming Donald Trump administration. The 2.3% medical device tax, enacted as part of Obamacare in 2010, took effect at...
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AngioSoma taps new CEO
AngioSoma (OTCQB:SOAN) said today that it named Ken Stephenson to the Montgomery, Texas-based company’s corner office. Alexanderia Blankenship will now serve as chief operating officer and executive...
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Researchers develop insulin-producing artificial beta cells
Researchers from ETH Zurich have developed artificial beta cells that can measure blood glucose concentration and respond by producing insulin. The team’s work was published this week in Science. The...
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