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China fines Johnson & Johnson in landmark price-fixing case

August 2, 2013 1:26 pm | by Mass Device | Comments

Johnson & Johnson (NYSE:JNJ) won the dubious distinction of being the 1st Fortune 500 company to be fined for price fixing in China, according to a newspaper there. The healthcare giant was fined 530,000 yuan (about $86,456) by the Shanghai High People's Court yesterday to compensate a former Chinese distributor, Rainbow Medical, China Daily reported.

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Cardiologist must cough up $17M in false Medicare billing case

August 2, 2013 1:13 pm | by Mass Device | Comments

A Washington, D.C., cardiologist was hit with a $17 million judgment after being found guilty of submitting false claims for nuclear imaging tests to Medicare and state health programs. Federal authorities accused Dr. Ishtiaq Malik of double-billing and submitting false claims for myocardial perfusion studies or "nuclear stress tests."

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Abiomed Surpasses 15,000 Impella Patients in the United States

August 2, 2013 8:45 am | by Globe Newswire | Comments

Abiomed, Inc., a leading provider of breakthrough heart support technologies, today reported that physicians have implanted more than 15,000 Impella® pumps in U.S. patients requiring hemodynamic support. The 15,000th Impella procedure took place at Mercy General Hospital in Sacramento, California with an Impella pump that provided prophylactic circulatory support.

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Thubrikar’s Next-Generation TAVI system surpasses ISO requirement for durability and achieves other milestones

August 1, 2013 6:27 pm | by Business Wire | Comments

Thubrikar Aortic Valve, a privately held medical device company developing a next-generation transcatheter aortic valve implantation (TAVI) system, announced today that its Optimum TAV has surpassed 200 million cycles in an ongoing durability test - which simulates over 5 years in humans and meets the requirement set by the International Organization for Standardization (ISO) - in a third party GLP study.

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Medical device tax repeal bill has 259 co-sponsors with more on the way

August 1, 2013 5:25 pm | by Mass Device | Comments

Representatives in the U.S. House are set to top last year's vote to repeal the 2.3% medical device excise tax. The "Protect Medical Innovation Act of 2013," co-sponsored by Reps. Erik Paulsen (R-Minn.) and Ron Kind (D-Wis.), has garnered 259 signatures, according to the Library of Congress' THOMAS database.

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FDA Clears Hologic's Single Energy Femur Exam to Visualize Features Associated with Developing Atypical Femur Fractures on a DXA Platform

August 1, 2013 4:07 pm | by PR Newswire | Comments

Hologic announced it received U.S. Food and Drug Administration (FDA) clearance for the Company's Single Energy (SE) Femur Exam on a dual energy x-ray absorptiometry (DXA) platform for the assessment of features associated with atypical femur fractures (AFF).

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Ambio Health lands 510(k) for home-based patient monitoring and data sharing

August 1, 2013 3:29 pm | by Mass Device | Comments

Ambio Health scored a green light from the FDA for its Ambio Remote Health Monitoring System, passing muster as a Class II device, the same category as wheelchairs and infusion pumps. The at-home monitoring system is designed to keep tabs on vital signs for patients with high blood pressure, heart disease and diabetes.

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Biopharmaceutical and Medical Device Associations Strongly Support Senate Bill to Exempt FDA User Fees from Sequestration

August 1, 2013 3:12 pm | by Business Wire | Comments

Today, Sen. Mark Pryor (D-AR), chairman of the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, and Sens. Roy Blunt (R-MO), Daniel Coats (R-IN), Al Franken (D-MN), and Jerry Moran (R-KS) introduced S. 1413 to exempt future Food and Drug Administration (FDA) user fees from sequestration.

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LeMaitre doesn’t win much Wall Street favor with record sales in Q2

August 1, 2013 2:29 pm | by Mass Device | Comments

LeMaitre Vascular posted an 8% bump in crofts for its 2nd quarter and raised guidance estimates for the year, but Wall Street was less than enthused. LMAT shares closed at a 1.7% decrease at $6.83 yesterday after the device maker posted record sales during a quarter that CEO George LeMaitre called "excellent."

World’s Largest Functional Brain Model

August 1, 2013 2:11 pm | by Maplesoft | Comments

A group of neuroscientists and software engineers at the University of Waterloo’s Computational Neuroscience Research Group (CNRG) have built the world’s largest functional model of the human brain. Named Spaun, the simulated brain has a digital eye which it uses for visual input, and a robotic arm that it uses to draw its responses.

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A New Tool for Brain Research

August 1, 2013 2:03 pm | by University of Nottingham | Comments

Physicists and neuroscientists from The University of Nottingham and University of Birmingham have unlocked one of the mysteries of the human brain, thanks to new research using functional Magnetic Resonance Imaging (fMRI) and electroencephalography (EEG).

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Wrong Site Surgery Cited as Top OR Safety Challenge Among U.S. Hospitals

August 1, 2013 2:00 pm | by Medline | Comments

Despite being a rare event, wrong site surgery is the number-one operating room safety concern for 65 percent of OR nurses in the United States, according to a new national survey conducted by Medline Industries, Inc. According to the Joint Commission Center for Transforming Healthcare, wrong site surgery occurs as often as 40 times per week in the U.S

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Health Data Exploration Survey Seeks Participants Who Self-Track Health

August 1, 2013 1:51 pm | by Calit2 | Comments

The Health Data Exploration project has announced a call for participants in an online survey that seeks to uncover insights into how individuals, companies and researchers are using the data that are captured through digital devices such as fitness apps.

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FDA expands clearance for Teleflex's Arrow balloon dilatation catheters

August 1, 2013 1:29 pm | by Mass Device | Comments

Teleflex (NYSE:TFX) won FDA clearance for expanded sizes and uses of its Arrow GPSCath Balloon Dilatation catheter, a device the company picked up during the 2012 buyout of Hotspur Technologies. The FDA win lets Teleflex sell the catheter in new 80 cm lengths and in a higher burst pressure rating.

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Welch Allyn Aims to Improve Patient Comfort and Safety with Acrylic Vaginal Specula and Cordless Illumination System

August 1, 2013 1:27 pm | by Welch Allyn | Comments

Welch Allyn, a leading medical diagnostic device company that specializes in helping clinicians improve patient outcomes, today announced a new promotion designed to help women’s health providers improve patient comfort and safety with its disposable KleenSpec® Vaginal Specula and Welch Allyn Cordless Illumination System.

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