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Lumendi wins FDA 510(k) for DiLumen endoscope positioning accessory
Medical device developer Lumendi said today it won FDA 510(k) clearance for its DiLumen endoscopic accessory. The Connecticut-based company’s DiLumen device is now indicated for use in positioning...
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The history of clinical research
For research professionals involved in clinical trials, there is an immense responsibility of protecting human subjects, but history has taught us, unethical practice and disregard for the well-being...
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Actelion, Sanofi in talks after J&J backs out of negotiations
Actelion (VTX:ATLN) and Sanofi (NYSE:SNY) are reportedly in talks to reach a takeover deal after Johnson & Johnson (NYSE:JNJ) said yesterday that it has closed negotiations with the Swiss biotech....
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FDA approves first bioresorbable scaffold with autologous cells for cartilage...
Vericel Corp (NSDQ:VCEL) shares soared 56% today after the Cambridge, Mass.-based company said the FDA approved its bioresorbable scaffold for cartilage repair. The product, Maci, is the 1st...
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Obama signs 21st Century Cures Act
President Obama yesterday signed the 21st Century Cures Act into law, the last step for the bill which has been 2 years in the making. Last week, the U.S. Senate voted 94-5 to pass the 21st Century...
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Eli Lilly, Express Scripts offer insulin discount program
Eli Lilly (NYSE:LLY) said it is teaming up with pharmacy benefit manager Express Scripts (NSDQ:ESRX) to offer discounts on the US pharma giant’s insulin products for uninsured patients and people with...
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Siemens invests $300m in Walpole, Mass facility
Siemens Healthineers (NYSE:SI) said today it is investing approximately $300 million over 4 years into its Walpole, Mass.-based laboratory diagnostics manufacturing and R&D facility. The Walpole...
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Zimmer Biomet closes $1B senior debt offering
Zimmer Biomet (NYSE:ZBH) said today it closed its an offering of Euro-dominated senior notes, bringing in over $1 billion. The company brought in $530 million (EU €500 million) in principal amount of...
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Bioventus picks up US Durolane rights from Galderma
Bioventus said today it inked a deal to pick up the U.S. rights for Durolane joint lubrication from Galderma for an undisclosed amount. Galderma’s Durolane is a single-injection, hyaluornic acid...
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AARP report details increase in brand name drug prices
The AARP Public Policy Institute released a report today showing that 2015 was the 4th straight year of double-digit average annual increases for widely used brand name drugs. The nonprofit...
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BioDelivery names Ginsberg as biz dev veep | Personnel Moves, Dec. 14, 2016
BioDelivery Sciences International (NSDQ:BDSI) said today that it named Peter Ginsberg as its VP of business development. Prior to joining the Raleigh, N.C.-based company, Ginsberg led business...
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Zimmer-Biomet launches PrimaGen advanced bone allograft
Zimmer Biomet (NYSE:ZBH) said today it launched the PrimaGen advanced bone allograft designed as an allogeneic bone graft substitute for use in the repair, replacement, reconstruction or...
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Researchers develop nanorockets that respond to changing temperatures
Researchers at Radboud University have developed nanorockets with temperature responsive “brakes”, enabling the carrier to stop in diseased tissues where temperatures are higher. The team’s work was...
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MassDevice.com +5 | The top 5 medtech stories for December 14, 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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Clarius wins FDA 510(k) for wireless ultrasound device
Mobile ultrasound developer Clarius Mobile Health said today it won FDA 510(k) clearance for its C3 and L7 Clarius wireless ultrasound scanners. Clarius’ C3 multipurpose ultrasound scanner is designed...
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GI Dynamics raises $1.1m in private placement
GI Dynamics (ASX:GID) said today it raised approximately $1.1 million (AU $1.5 million) and announced an upcoming security purchase plan looking to raise an additional $732,006 (AU $987,910). The...
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Fresenius inks 5-year distro deal with Terumo to launch CATSmart in US
Fresenius (NYSE:FMS) business group Fresenius Kabi said today it inked a 5-year exclusive distribution deal with Terumo Corp. (TYO:4543) to launch Fresenius’ CATSmart autotransfusion system in the US....
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J&J’s LifeScan wins FDA clearance for WellDoc integration of blood glucose data
Johnson & Johnson (NYSE:JNJ) subsidiary LifeScan said today it won FDA clearance for wireless integration of its OneTouch Verio Flex blood glucose monitoring system with WellDoc‘s FDA-approved...
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Key elements of a viable post-market surveillance system
By Stewart Eisenhart, Emergo Group Although premarket registration and quality management system compliance garner a lot of attention from medical device companies eager to establish themselves in...
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Hologic deals stake in Procleix blood-screening biz to Grifols for $1.9B
Hologic (NSDQ:HOLX) said yesterday that it agreed to deal its stake in the Procleix blood-screening business it runs with Grifols (NSDQ:GRFS) for nearly $1.9 billion. Hologic, which makes the Procleix...
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