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Guidant imposed criminal penalty over $296M for withholding cardioverter defibrillator failure information

Guidant LLC pleaded guilty today in St. Paul, Minn., before U.S. District Court Judge Donovan W. Frank to criminal violations of the Federal Food, Drug and Cosmetic Act, the Justice Department announced. The medical device manufacturer's admission of criminal wrongdoing is the result of a four-year investigation into Guidant's handling of short-circuiting failures of three models of its implantable cardioverter defibrillators: the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155).

7 Apr 2010

AbleNet adds Madentec's entire line of assistive technology solutions to product portfolio

AbleNet, Inc. announces the agreement with Madentec Limited of Edmonton, Alberta, Canada for the exclusive global rights to manufacture and sell their entire line of assistive technology solutions. This adds a broad portfolio of proven devices to the AbleNet computer access products. Madentec will continue to own the products and provide engineering development support, which has been their core strength.

7 Apr 2010

BD Diagnostics adds Innova Preanalytical Automated Microbiology Specimen Processor to product portfolio

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced today the expansion of its product portfolio with the addition of the BD Innova™ Preanalytical Automated Microbiology Specimen Processor, which is designed to help increase laboratory efficiency and automate the modern microbiology laboratory.

From BD (Becton, Dickinson and Company) 7 Apr 2010

Rome Foundation develops Diagnostic Algorithms to diagnose GI symptoms

New clinical algorithms will give physicians a practical, efficient and cost-effective aid to diagnose the frequent gastrointestinal symptoms that patients commonly bring to their primary care doctors and gastroenterologists--symptoms of functional GI disorders that are often difficult to diagnose.

7 Apr 2010

SRU Biosystems extends product line with the introduction of BIND SCANNER

SRU Biosystems today announced the extension of its product line of label-free instrumentation and biosensors with the introduction of its BIND® SCANNER for primary and stem cell applications. The BIND SCANNER is a first-of-its-kind, plate-based, label-free instrument capable of monitoring cellular responses at an individual cell resolution.

7 Apr 2010

FDA grants 510(k) clearance for STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System

STERIS Corporation today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the STERIS SYSTEM 1E® Liquid Chemical Sterilant Processing System.

7 Apr 2010

Berwick, Blumenthal may form dream team at CMS

Healthcare IT News: "If Donald Berwick, MD, is confirmed as administrator of the Centers for Medicare and Medicaid Services, he and David Blumenthal, MD, the national coordinator for health IT, would be a 'dream team' in pursuing a coherent national healthcare and health IT strategy. At least that's the assessment of Kerry Weems, who spent 25 years in senior roles at the Health and Human Services Department and was acting administrator of CMS from Sept. 2007 until the Obama administration took over.

7 Apr 2010

IGRAs effective for detecting confirmed active TB disease: CHEST

New data from a meta-analysis of existing literature published today in CHEST, the official journal of the American College of Chest Physicians, demonstrate that Interferon Gamma Release Assays are superior to the previous standard in diagnostics, the 100+-year-old tuberculin skin test, for detecting confirmed active Tuberculosis disease.

7 Apr 2010

Accumetrics completes enrollment phase of GRAVITAS clinical trial

Accumetrics, Inc., a privately-held developer and marketer of the VerifyNow® System, the first rapid and easy to use point-of-care system for measuring platelet reactivity to multiple antiplatelet agents, announced that it has completed the enrollment phase of its landmark clinical trial, GRAVITAS.

7 Apr 2010

New web-based technology platform for late phase clinical research

PAREXEL International Corporation, a leading global biopharmaceutical services provider, today announced that it has introduced a new web-based technology platform for late phase clinical research to meet the expanding regulatory and commercialization needs of the biopharmaceutical industry.

6 Apr 2010

New study shows utility of Chronix Biomedical's serum DNA tests in MS

Chronix Biomedical today announced publication of a study that supports the utility of its serum DNA blood tests to predict clinical status and monitor disease activity and response to treatment in multiple sclerosis. Chronix Biomedical uses proprietary technology to identify disease-specific genetic fingerprints based on the circulating DNA that is released into the bloodstream by damaged and dying cells.

6 Apr 2010

SANUWAVE Health announces completion of patient enrollment in dermaPACE Phase III clinical trial

SANUWAVE Health, Inc., an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in the regenerative medicine area, today announced that patient enrollment was completed in March in its dermaPACE™ Phase III pivotal, randomized, double-blinded, sham controlled, multicenter clinical trial comparing its Pulsed Acoustic Cellular Expression technology, utilizing the dermaPACE™ tissue regeneration device, to sham control for the treatment of diabetic foot ulcers.

6 Apr 2010

New head-mounted display system lets anesthesiologists focus on monitoring data during surgery

A new head-mounted display system lets anesthesiologists keep an eye on critical monitoring data during surgery—without having to turn their attention away from the patient, reports a study in the April issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society.

6 Apr 2010

DLVSC offers Zeltiq procedure to freeze away unwanted fat cells

Zeltiq™, an innovative technology that freezes away unwanted fat, is now available at Dermatology, Laser and Vein Specialists of the Carolinas – making DLVSC one of the first medical practices in the Southeast to offer this breakthrough in fat reduction.

6 Apr 2010

University of Wisconsin-Madison uses ultrasensitive detector to find fetal heart rhythm problems

At the University of Wisconsin-Madison, one of the most powerful magnetic detectors in the world is helping screen high-risk pregnant patients for rare but very serious fetal heart rhythm problems. Thanks to a collaboration with The Medical College of Wisconsin, Milwaukee; Children's Hospital of Wisconsin, Milwaukee; and Hope Children's Hospital, Chicago, the ultrasensitive detector measures magnetic signals coming from the tiny beating hearts of fetuses.

6 Apr 2010

TAP to showcase performance of Fill-It dispensing system at SBS Conference

The Automation Partnership, a world leader in the design and development of innovative automation for life science applications, announces it will be showcasing the performance of its Fill-It™, benchtop automated dispensing system with a fun "Man versus Fill-It Challenge" on Booth 517 at the Society of Biomolecular Screening Conference, on April 11-15.

6 Apr 2010

Nanoparticle-core polymer holds promise as weight-bearing replacement for traditional graft materials

Orthopedic surgeons are often hamstrung by less-than-ideal grafting material when performing surgeries for complex bone injuries resulting from trauma, aging or cancer. Conventional synthetic bone grafts are typically made of stiff polymers or brittle ceramics, and cannot readily conform to the complex and irregular shapes that often result from injury; in addition, they often require metallic fixation devices that require open surgeries to insert and remove.

6 Apr 2010

MHS to deploy NextGen EHR and NextGen HIE management solutions

NextGen Healthcare Information Systems, Inc., a wholly owned subsidiary of Quality Systems, Inc. and a leading provider of healthcare information systems and connectivity solutions, today announced an agreement with Mercy Health System to deploy NextGen® EHR and NextGensm Health Information Exchange.

6 Apr 2010

ITI to lead multi-university consortium to improve patient outcomes

The U.S. health care community has increasingly been adopting the use of electronic medical records and other electronic health information systems, but serious concerns about the security and privacy of those systems have been raised.

6 Apr 2010

Achievements of AFC, Abbott to be highlighted at AFC's 25th Anniversary Gala

Two events occurred in 1985 that proved pivotal in the local and national fight against AIDS: the founding of the AIDS Foundation of Chicago and the development of the first-ever diagnostic test licensed to identify HIV in the blood by Abbott.

6 Apr 2010

Device / Technology News

Guidant imposed criminal penalty over $296M for withholding cardioverter defibrillator failure information

AbleNet adds Madentec's entire line of assistive technology solutions to product portfolio

BD Diagnostics adds Innova Preanalytical Automated Microbiology Specimen Processor to product portfolio

Rome Foundation develops Diagnostic Algorithms to diagnose GI symptoms

SRU Biosystems extends product line with the introduction of BIND SCANNER

FDA grants 510(k) clearance for STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System

Berwick, Blumenthal may form dream team at CMS

IGRAs effective for detecting confirmed active TB disease: CHEST

Accumetrics completes enrollment phase of GRAVITAS clinical trial

New web-based technology platform for late phase clinical research

New study shows utility of Chronix Biomedical's serum DNA tests in MS

SANUWAVE Health announces completion of patient enrollment in dermaPACE Phase III clinical trial

New head-mounted display system lets anesthesiologists focus on monitoring data during surgery

DLVSC offers Zeltiq procedure to freeze away unwanted fat cells

University of Wisconsin-Madison uses ultrasensitive detector to find fetal heart rhythm problems

TAP to showcase performance of Fill-It dispensing system at SBS Conference

Nanoparticle-core polymer holds promise as weight-bearing replacement for traditional graft materials

MHS to deploy NextGen EHR and NextGen HIE management solutions

ITI to lead multi-university consortium to improve patient outcomes

Achievements of AFC, Abbott to be highlighted at AFC's 25th Anniversary Gala

The future of automation: Machine learning–driven hepatocyte and organoid counting

From street to lab: Advancing controlled substance testing with handheld Raman and FTIR

Reimagining light scattering for biotherapeutics

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