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RF-TVA Therapy Offers Hope for Patients Suffering from Osteoporosis-Related Spine Fractures

May 2, 2012 6:17 am | News | Comments

In observance of National Osteoporosis Awareness Month in May, DFINE, Inc., the developer of minimally invasive radiofrequency (RF) targeted therapies for the treatment of vertebral pathologies, encourages patients to learn about the risks of spine fractures...

Titan Spine Announces the Release of Cellular Data on Its Surface Technology

May 2, 2012 6:14 am | News | Comments

Titan Spine, a medical device surface technology company focused on the development of innovative spinal interbody fusion implants, announced today that an article published in The Spine Journal reports in-vitro data that demonstrates a superior bone-forming response...

Scientists reveal early diagnostic clues for AD using advanced brain imaging technology

May 2, 2012 6:12 am | News | Comments

Alzheimer's disease is a major neurodegenerative disorder that affects millions of people worldwide. New and accurate techniques for early diagnosis are critical. Pravat K. Mandal, PhD, and his colleagues have developed a completely non-invasive brain imaging technique...

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Invuity's Eigr Technology Featured at American Society of Breast Surgeons' Annual Meeting

May 2, 2012 6:08 am | News | Comments

Invuity, a leading developer of state-of-the-art surgical visualization and illumination technology, today announced that its advanced Eigr™ Breast Retractor System will be featured in several key presentations and demonstrations at the American Society of Breast Surgeons'...

The future of AF ablation catheter technologies

May 2, 2012 5:51 am | News | Comments

Design and technology consultancy Cambridge Design Partnership today announces that it has completed a research project to identify the future of medical technology to treat Atrial Fibrillation; a common and dangerous Cardiac condition affecting millions of people across the world.

London’s Air Ambulance Trialling Brain-Cooling Device in Cardiac Arrest Patients

May 2, 2012 5:29 am | News | Comments

London’s Air Ambulance, the Charity which runs London’s Helicopter Emergency Medical Service, has become the first in the UK to trial a novel device for directly cooling the brain using evaporative, nasal spray technology, the RhinoChill® IntraNasal Cooling System...

Consumer Information on: Presillion plus CoCr Coronary Stent on RX System - P110004

May 1, 2012 8:30 am | by U.S. Food & Drug Administration | News | Comments

The Presillion plus CoCr Coronary Stent on RX System is a metal stent that is mounted on a folded balloon attached to a catheter delivery system for placement into a blood vessel supplying blood to the heart (coronary artery). The stent is made of a...

Summary Information for: Presillion plus CoCr Coronary Stent on RX System

May 1, 2012 8:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Presillion plus CoCr Coronary Stent on RX System (P110004).

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First Patient Treated in U.S. Clinical Study of Cohera Medical’s TissuGlu Surgical Adhesive

May 1, 2012 5:45 am | News | Comments

Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced the treatment of the first patient in a prospective, multicenter, randomized clinical trial for its lead product, TissuGlu® Surgical Adhesive in the United States.

Sparton Medical Recognized for Teaming with BioMarker Strategies and HS Design to Automate Live Tumor-Cell Processing

May 1, 2012 4:45 am | by The Associated Press | News | Comments

Sparton Medical Recognized for Teaming with BioMarker Strategies and HS Design to Automate Live Tumor-Cell Processing STRONGSVILLE, Ohio--(BUSINESS WIRE)--May 1, 2012-- Sparton Corporation (NYSE:SPA) announces that Sparton Medical's collaborative design and engineering work with HS Design in...

GE Healthcare Enhances Workflow in Echo Lab, OR and Cath Lab with Vivid E9 Cardiovascular Ultrasound, Now Including 4D TEE Transducer

April 25, 2012 5:56 am | News | Comments

WAUWATOSA, Wis.--(BUSINESS WIRE)--GE Healthcare, a unit of General Electric Company (NYSE: GE), today announced the FDA clearance and availability of the latest version of its Vivid E9â„¢ cardiovascular ultrasound system. The Vivid E9 Breakthrough 2012 (BT12) includes...

Defibtech Introduces TSO-Authorized Aviation Battery for Lifeline VIEW AED

April 25, 2012 5:49 am | News | Comments

GUILFORD, Conn.--(BUSINESS WIRE)--Defibtech today introduced the TSO-C142a-authorized aviation battery for the Lifelineâ„¢ VIEW automated external defibrillator (AED). Following rigorous testing, the aviation battery passed the aircraft industry's required safety and performance standards.

DENTSPLY Implants launches ATLANTIS Abutment for the ANKYLOS Implant System in North America

April 25, 2012 5:47 am | News | Comments

WALTHAM, Mass.--(BUSINESS WIRE)--After the recently announced union of DENTSPLY Friadent and Astra Tech Dental into the new company DENTSPLY Implants, DENTSPLY Implants North America announces its first product release with the expansion of the ATLANTIS...

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Toshiba's AIDR 3D Receives FDA Clearance

April 25, 2012 5:44 am | News | Comments

TUSTIN, Calif.--(BUSINESS WIRE)--Toshiba America Medical Systems, Inc. announces the FDA clearance of Adaptive Iterative Dose Reduction 3D (AIDR 3D), the company's newest dose-reduction technology. Toshiba will offer the AIDR 3D software upgrade and related training...

Ellis Medicine Unveils New Tool to Enhance Patient Safety

April 25, 2012 5:41 am | News | Comments

SCHENECTADY, N.Y.--(BUSINESS WIRE)--In an ongoing effort to improve patient safety, Ellis Medicine is the first hospital in the region, second in the state, to use Xenex's innovative germ-zapping technology to keep patients even safer from infections.

New Microdevice Enables Culture of Rare Circulating Tumor Cells from Blood

April 25, 2012 5:35 am | News | Comments

A research collaboration between the Wyss Institute for Biologically Inspired Engineering at Harvard University and Children's Hospital Boston has created a microfluidic device that can harvest rare circulating tumor cells (CTCs) from blood to enable their expansion...

X-Rock: Recall - Undeclared Drug Ingredient

April 25, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

Undeclared active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels.

Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays: Recall – Doctors may receive a falsely low result

April 24, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments

Customers should immediately discontinue use of any affected product.

Class I Medical Device Recall: Roche Diagnostics Operations, Inc., Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays

April 24, 2012 8:31 am | by U.S. Food & Drug Administration | News | Comments

With certain types of plasma samples, doctors may receive a falsely low result (up to a maximum of 50% lower than the actual concentration of Troponin I). These incorrect results may cause serious adverse health consequences, including death.

NIST Panel: FDA Should Regulate Device Cybersecurity, Hacking Risks

April 20, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

The potential for hacking into software-operated medical devices could pose a serious patient safety risk, a board convened by the National Institute of Standards and Technology (NIST) maintains.

MDUFA: Despite Broad Agreement, 510(k) Safety Concerns Remain

April 20, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Stakeholders agree on the majority of the Medical Device User Fee Act (MDUFA) reauthorization legislation now before Congress, but that didn’t make a House health subcommittee hearing on device and drug user fees smooth sailing.

Aliskiren-containing Medications: Drug Safety Comunication - New Warning and Contraindication

April 20, 2012 8:30 am | by U.S. Food & Drug Administration | News | Comments

Risk of renal impairment, hypotension, and hyperkalemia with concomitant use of aliskiren with angiotensin receptor blockers (ARBs) or angiotensin converting enzyme inhibitors (ACEIs) in patients with diabetes.

GE Healthcare to Develop Next Generation Compact Cyclotron and PET Tracer System for Global Markets

April 20, 2012 5:50 am | News | Comments

GE Healthcare, a unit of General Electric Company (NYSE: GE), and NXT2B, a privately owned venture capital company, today announced they have entered into a joint financing agreement with the goal of developing a micro-scale radiotracer infrastructure including cyclotron...

Carestream Health Receives FDA Clearance for New DRX-Revolution Mobile X-Ray System

April 20, 2012 5:47 am | News | Comments

Carestream received U.S. Food and Drug Administration (FDA) clearance for its CARESTREAM DRX-Revolution Mobile X-Ray System, and is now accepting orders from U.S. healthcare facilities. European and Canadian healthcare providers are also placing orders...

Entellus Medical One-Year Study Results Reaffirm XprESS Multi-Sinus Dilation Tool Safe and Effective in Treatment of Chronic Sinusitis

April 20, 2012 5:44 am | News | Comments

One-year results presented by Dr. David Brodner today during the annual Combined Otolaryngology Spring Meeting in San Diego demonstrate that the Entellus Medicalâ„¢ XprESSâ„¢ Multi-Sinus Dilation Tool may be used safely and with sustained effectiveness to treat...

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