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ActiViews CT-Guide Needle Guidance System for liver interventions receives FDA 510(k) clearance

ActiViews, Inc, a company pioneering the development of simple, accurate, and cost-effective surgical navigation solutions, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its flagship product, CT-Guide Needle Guidance System, for liver interventions.

23 Apr 2012

Champ Medics to market ETView's VivaSight airway management platform in Taiwan

ETView Medical, Ltd. announced today that it has entered into a distribution agreement with Champ Medics Co., Ltd..

23 Apr 2012

Study describes new method to manufacture nerve guidance conduits

Engineers at the University of Sheffield have developed a method of assisting nerves damaged by traumatic accidents to repair naturally, which could improve the chances of restoring sensation and movement in injured limbs.

23 Apr 2012

FDA draft guidance documents address use of nanotechnology by food and cosmetics industries

Two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries were issued today by the U.S. Food and Drug Administration.

21 Apr 2012

New wiki of medical devices designed for resource-limited settings

In parts of the world without reliable electricity, a pedal-powered nebulizer could provide life-saving asthma treatments. Small wax-filled sleeping bags could keep premature infants warm. A salad spinner centrifuge for blood samples could help clinicians diagnose anemia.

20 Apr 2012

Obama and Romney start long-distance debate over Medicare

President Barack Obama and GOP presidential hopeful Mitt Romney have started a long-distance, health care debate, fighting over how to reform the Medicare system. Other politicians are getting in on the act too, as Sen. Jim Webb, D-Va., and Mass. Senate hopeful Elizabeth Warren give their two cents on the health reform law.

20 Apr 2012

First Edition: April 18, 2012

Today's health policy headlines include reports about how a one-year experiment on Medicare competitive bidding showed positive results in terms of saving money as well as reducing waste and fraud.

19 Apr 2012

CRF announces top 10 clinical research achievement awards

Ten outstanding clinical research projects from institutions around the country have been selected to receive the inaugural Clinical Research Forum Top 10 Clinical Research Achievement Awards. The winning projects are compelling examples of the scientific innovation that results from the nation's investment in clinical research that can benefit human health and welfare.

19 Apr 2012

Viewpoints: Insurance regulation a 'special interest'?; Washington's wrong health care battle; Will the health law turn us into part-time employees?

It takes a certain amount of chutzpah to name a group that opposes government oversight of health insurance premiums "Californians Against Higher Healthcare Costs." Especially when the group includes the trade associations for doctors and hospitals, two sets of Californians who've contributed mightily to the high cost of health care.

19 Apr 2012

USP convenes pharmaceutical supply chain integrity workshop

The increasing globalization of the drug supply presents a host of public health challenges: theft and diversion of medicines, growth of illegal Internet pharmacies and insertion of adulterated medicines or ingredients into the supply chain.

18 Apr 2012

Entitlement programs at center of Capitol Hill's gathering budget storm

The likely and emerging partisan clash in Congress could force GOP presidential hopeful Mitt Romney to take difficult policy positions in the fall -- just as the campaign is coming to an end. Meanwhile, this week on Capitol Hill, lawmakers will wrestle with a number of health care issues.

17 Apr 2012

FDA grants 510(k) clearance for QIAGEN’s molecular detection PCR technology

QIAGEN N.V. today announced that the U.S. Food and Drug Administration (FDA) has granted two 510(k) clearances for its real-time PCR (polymerase chain reaction) instrument Rotor-Gene Q MDx and a compatible test for the detection of Influenza A/B, the artus Infl A/B RG RT-PCR Kit, for in vitro diagnostic use.

From QIAGEN Manchester Limited 17 Apr 2012

Osprey Medical closes IPO raising of A$20 million

Osprey Medical Inc, has today announced that its Initial Public Offer (IPO) raising of A$20 million has closed. Osprey Medical’s Offer was well supported by institutional and retail investors in Australia, including founding investors CM Capital and Brandon Capital. The Initial Public Offer was underwritten by Shaw Corporate Finance.

17 Apr 2012

St. Jude Medical's Ellipse ICD receives CE Mark Approval

St. Jude Medical, Inc., a global medical device company, today announced CE Mark Approval of the Ellipse implantable cardioverter defibrillator (ICD). Designed with feedback from more than 200 physicians from around the world, the Ellipse ICD provides the benefits of advanced features and power in the industry's smallest high-energy ICD.

16 Apr 2012

Implantable device with alert modes warns users about potential heart attack

More than 30% of the one million heart attack victims in the United States each year die before seeking medical attention. Although widespread education campaigns describe the warning signs of a heart attack, the average time from the onset of symptoms to arrival at the hospital has remained at 3 hours for more than 10 years.

16 Apr 2012

U-Systems receives positive FDA panel review for somo•v ABUS system for breast cancer screening

U-Systems, the leader in automated breast ultrasound, today announced that the U.S. Food and Drug Administration's Radiological Devices Panel of the Medical Devices Advisory Committee recommended approval of the somo•v Automated Breast Ultrasound (ABUS) system.

12 Apr 2012

Gerresheimer first quarter revenues increase 13.6% to EUR 268.8m

Gerresheimer has experienced particularly strong growth in revenues in the first quarter of the 2012 financial year.

12 Apr 2012

FDA approves Medtronic’s expanded indication for implantable CRT-D devices

Medtronic, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for its cardiac resynchronization therapy with implantable cardioverter defibrillator (CRT-D) devices.

From Medtronic 11 Apr 2012

Vilex announces commercial launch of FUZE TTC Arthrodesis Compression Nail

Vilex Inc., a leader in innovative orthopaedic medical devices announced the commercial launch of the FUZE TTC Arthrodesis Compression Nail, the most recent addition to the Vilex line.

11 Apr 2012

Intact Vascular’s Tack-it Endovascular Stapler device receives CE Mark approval

Intact Vascular, a medical device company and developer of products for minimally invasive peripheral vascular procedures, today announced its European notified body has granted the company ISO Certification and CE Mark approval for Tack-it Endovascular Stapler device.

11 Apr 2012