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FDA approves St. Jude Medical’s SyncAV CRT software
St. Jude Medical (NYSE:STJ) said today that the FDA approve its SyncAV cardiac resynchronization therapy software, which is designed to automatically adjust pacing based on real-time changes in a...
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Amgen taps West’s SmartDose for Pushtronex system
Amgen (NSDQ:AMGN) is partnering with West Pharmaceutical Services to integrate its SmartDose delivery platform into its Pushtronex system, the companies said today. The SmartDose technology is designed...
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Tissue Regenix CE Mark expected 6 months early
Tissue Regenix said today it expects to pick up CE Mark approval in the European Union for its OrthoPure XT and XM procine tendon and meniscus products approximately 6 months ahead of schedule....
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FDA approves Insightec’s Exablate Neuro focused ultrasound device
UPDATED July 12, 2016, with comment from study investigators, Insightec CEO. The FDA said today that it approved the Exablate Neuro device made by Insightec for treating essential tremor in patients...
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Sunshine Heart looks towards neuromodulation for its C-Pulse device
Sunshine Heart (NSDQ:SSH) said today it is looking at therapeutic strategies focused on neuromodulation rather than counterpulsation, touting the shift as a more cost effective strategy with a faster...
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DEKA’s LUKE prosthetic robotic arm set to debut later this year
The robotic LUKE arm developed by Dean Kamen’s DEKA research and development company is looking to hit the market later this year, being commercialized by Mobius Bionics. The LUKE arm is designed as a...
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MassDevice.com +5 | The top 5 medtech stories for July 11, 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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3Scan raises $14m to support tissue research platform
Computational pathology service platform developer 3Scan said today it raised $14 million in a Series B round of financing to support the expansion of its pre-clinical drug discovery capabilities and...
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Getinge wins expanded FDA clearance for Sterizone VP4
Getinge (PINK:GETI B) said today it won expanded FDA clearance for its Sterizone VP4 sterilizer, now cleared to sterilize colonoscopes, gastroscopes and other multi-channel flexible endoscopes of up to...
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Massive study points to genetic basis for diabetes
(Reuters) – A study examining the genes of more than 120,000 people from Europe, Asia, Africa and the Americas has offered the clearest picture yet of the genes that drive type 2 diabetes. The study,...
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Sirtex jumps on higher-than-expected microsphere sales
Sirtex Medical today saw shares rise as much as 6.5% today after reporting higher than expected sales of its SIR-Spheres Y-90 resin microspheres for the 12 months ended June 30. That’s 16.4% up from...
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Titan Spine wins new Medicare code
Titan Spine said today it won a new technology ICD-10 code from the U.S. Centers for Medicare & Medicaid Services, which allows for nanotextured surfaces on interbody fusion devices, clearing its...
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FDA officials want a national review system for medical devices
A pair of top officials at the FDA are advocating for a national oversight system for medical devices that would combine pre- and post-market clinical studies with adverse event reporting and...
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MTD Micro Molding Achieves ISO 13485 Certification
After years of ISO 13485 compliance, MTD Micro Molding (www.mtdmicromolding.com), a long-time leader in micro-injection molding for the medical device industry, announced it has achieved ISO 13485...
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Abiomed sues Maquet over Impella patents
Threatened with a patent infringement lawsuit if it didn’t agree to a licensing deal with Maquet, Abiomed (NSDQ:ABMD) responded by asking a Massachusetts judge for a judgment of non-infringement last...
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Risk Management in Clinical Research
As the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a whitepaper that discusses the principles of risk management and their application to...
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RAUMEDIC celebrates 20 years in Zwönitz
From left to right: Elvira Halberkorn – Zwönitz Office of Public Order; Jens Rausendorf – Production Manager at RAUMEDIC AG Zwönitz; Andy Kehrer, representing the Mayor’s Office of the City of Zwönitz...
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Burberry poaches Smith & Nephew CFO Brown | Personnel Moves for July 12, 2016
Burberry poaches Smith & Nephew CFO Brown Smith & Nephew (NYSE:SNN) said yesterday that CFO Julie Brown is leaving the company in January 2017 after 4 years on the job at the British healthcare...
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TransMedics adds $13m to $51m funding round
TransMedics said yesterday that it added $12.5 million to the $51.2 million equity round it closed in May, taking its total raise to more than $63.7 million. Andover, Mass.-based TransMedics developed...
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Mazor unveils Maxor X robotic spinal surgery platform
Mazor Robotics (NSDQ:MZOR) today unveiled its Mazor X robotic spinal surgery system, designed to combine analytical tools, precision guidance, optical tracking and intra-operative verification into a...
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