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Health care action at state capitols: Hospital fees, abortion, nurses' power to write prescriptions

Lawmakers around the country consider a bevy of bills related to health policy.

10 Feb 2013

Shire commences ABH001 Phase 3 study in Epidermolysis Bullosa

Shire plc, today announced the initiation of a Phase 3 study designed to evaluate the efficacy and safety of ABH001, its dermal substitute therapy, for the treatment of non-healing wounds in patients with Epidermolysis Bullosa (EB), a group of rare genetic skin disorders that begin to manifest at birth or early childhood and occur in approximately 19 per 1 million live births in the US.

10 Feb 2013

Weekend reading: Mental health discrimination; A doctor faces hard questions; Long-term outlook for health care jobs

"When I had cancer, I got cards and flowers," Karen Kangas' sign reads. "When I was diagnosed with bipolar disorder, I got no cards and a pink slip." A picture of Kangas holding the sign hangs in the state Capitol complex, part of an exhibit called "Discrimination: A Roadblock to Recovery."

9 Feb 2013

Cantor calls for repeal of medical device tax; Bipartisan Senate bill seeks to end generic drug delays

In a speech, the House majority leader criticized the health law but focused his attention on the overhaul's taxes. Meanwhile, the Senate measure would prohibit companies that make brand-name drugs from paying generic manufacturers to keep their products off the market.

7 Feb 2013

Misonix revenue increases 19% to $8.0M for six months ended December 31, 2012

Misonix, Inc., a surgical device company that designs, manufactures and markets innovative therapeutic ultrasonic products worldwide for spine surgery, cranial maxillo – facial surgery, neurosurgery, wound debridement, cosmetic surgery, laparoscopic surgery and other surgical applications, today reported financial results for the six-months and the second quarter of fiscal year 2013, ended December 31, 2012.

7 Feb 2013

ZOLL's Intravascular Temperature Management solution receives Shonin approval in Japan

ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to enter the Japanese market with its Intravascular Temperature Management (IVTM) technology—the first intravascular temperature management system to receive Shonin approval in Japan.

6 Feb 2013

Thoratec fourth quarter revenues increase 17% to $128.5 million

Thoratec Corporation, a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, today reported its financial results for the fourth quarter of 2012.

5 Feb 2013

Fluke Biomedical debuts new VT305 Gas Flow Analyzer

Fluke Biomedical, a global provider of medical device test and safety equipment, announced today the debut of its new VT305 Gas Flow Analyzer. Designed for the highly mobile biomed or service engineer, the small lightweight VT305 is simple to use, provides quick results and is engineered for efficiency.

5 Feb 2013

BD first quarter revenues increase 3.7% to $1.90 billion

BD, a leading global medical technology company, today reported quarterly revenues of $1.90 billion for the first fiscal quarter ended December 31, 2012, representing an increase of 3.7 percent from the prior-year period, or 5.2 percent on a foreign currency-neutral basis.

From BD (Becton, Dickinson and Company) 5 Feb 2013

ATI Neurostimulation System demonstrates clinical effectiveness in treating cluster headache

Autonomic Technologies, Inc. (ATI), the developer of the ATI Neurostimulation System designed for the treatment of severe headaches, today announced results of their clinical study in cluster headache, now published online in Cephalalgia.

5 Feb 2013

NeuroSigma receives third NIH grant to develop subcutaneous trigeminal nerve stimulation for DRE

NeuroSigma, Inc., a California-based medical device company, today announced it received a Notice of Award, for a Fast Track Small Business Innovation Research (SBIR) grant, from the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH).

5 Feb 2013

St. Jude Medical initiates Portico Transfemoral European Trial in severe aortic stenosis

St. Jude Medical, Inc., a global medical device company, today announced the first patient implant of its 25 mm Portico Transcatheter Aortic Heart Valve using the Transfemoral Delivery System in its ongoing European trial.

5 Feb 2013

FDA approves K7 LLC's K7C Cervical Spacer for use as IBF device

K7 LLC's K7C Cervical Spacer, a spinal implant device using Evonik's VESTAKEEP PEEK (polyetheretherketone), has received the U.S. Food and Drug Administration's (FDA) 510(k) approval for use as an Intervertebral Body Fusion (IBF) device.

4 Feb 2013

FDA announces federal judge approval of Ben Venue consent decree

The U.S. Food and Drug Administration announced today that a federal judge has approved a consent decree of permanent injunction against Ben Venue Laboratories, Inc., and three of its corporate officers for failing to comply with current good manufacturing practice requirements as required by federal law.

2 Feb 2013

Viewpoints: Congress must put entitlements on 'more sustainable path;' Reading, writing and mental health screenings

What's needed now is a clear, achievable plan to bring the debt and deficit under control for the long term. A crucial part of any such plan is promoting a more vigorous economy, possibly by simplifying the federal tax code. Another important piece is putting entitlements on a more sustainable path, reducing the drain on the Treasury. That means expanding on the 2010 healthcare law's efforts to increase efficiency, quality and innovation in healthcare.

1 Feb 2013

Mental health in young people: an interview with Professor Colum Dunne

Ireland, and many other countries, is witnessing increases in problematic and complex youth mental health challenges. In Ireland, specifically, there has been a rash of high profile cases where young people have unfortunately not been able to deal with stress, bullying and other issues.

1 Feb 2013

Span-America first quarter net income increases 21% to $1.4 million

Span-America Medical Systems, Inc. today reported higher sales and net income for the first quarter ended December 29, 2012.

31 Jan 2013

Kraton Polymers' Cariflex polyisoprene products to be showcased at MEDTEC Europe

Kraton Performance Polymers, Inc., a leading global producer of styrenic block copolymers and other engineered polymers, announces plans to showcase Cariflex polyisoprene products, the pure and clean alternative to natural rubber for high performance medical applications, at MEDTEC Europe in Stuttgart, Germany.

31 Jan 2013

FDA allows Arteriocyte to commence Magellan System Phase I trial in thermal burn wounds

Arteriocyte, a leading biotechnology company with offices in Cleveland, Ohio and Hopkinton, Massachusetts announced today approval from the Food and Drug Administration (FDA) to initiate a Phase I clinical trial using its Magellan System technology in the treatment of thermal burn wounds.

31 Jan 2013

Velomedix commences rapid therapeutic hypothermia system pilot study in heart attack

Velomedix, a venture-backed medical device company advancing the field of therapeutic hypothermia, today announced the enrollment of the first patient in its VELOCITY pilot study.

31 Jan 2013

Medical Devices News and Research

Health care action at state capitols: Hospital fees, abortion, nurses' power to write prescriptions

Shire commences ABH001 Phase 3 study in Epidermolysis Bullosa

Weekend reading: Mental health discrimination; A doctor faces hard questions; Long-term outlook for health care jobs

Cantor calls for repeal of medical device tax; Bipartisan Senate bill seeks to end generic drug delays

Misonix revenue increases 19% to $8.0M for six months ended December 31, 2012

ZOLL's Intravascular Temperature Management solution receives Shonin approval in Japan

Thoratec fourth quarter revenues increase 17% to $128.5 million

Fluke Biomedical debuts new VT305 Gas Flow Analyzer

BD first quarter revenues increase 3.7% to $1.90 billion

ATI Neurostimulation System demonstrates clinical effectiveness in treating cluster headache

NeuroSigma receives third NIH grant to develop subcutaneous trigeminal nerve stimulation for DRE

St. Jude Medical initiates Portico Transfemoral European Trial in severe aortic stenosis

FDA approves K7 LLC's K7C Cervical Spacer for use as IBF device

FDA announces federal judge approval of Ben Venue consent decree

Viewpoints: Congress must put entitlements on 'more sustainable path;' Reading, writing and mental health screenings

Mental health in young people: an interview with Professor Colum Dunne

Span-America first quarter net income increases 21% to $1.4 million

Kraton Polymers' Cariflex polyisoprene products to be showcased at MEDTEC Europe

FDA allows Arteriocyte to commence Magellan System Phase I trial in thermal burn wounds

Velomedix commences rapid therapeutic hypothermia system pilot study in heart attack

Industry Focus eBook - Medical Devices (3rd Edition) eBook

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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