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FDA clears first automated molecular tests to diagnose and differentiate HSV infection

BD Diagnostics, a segment of BD, announced today that it filed for U.S. Food and Drug Administration 510(k) clearance for the first fully automated molecular tests to diagnose and differentiate HSV types 1 and 2.

From BD (Becton, Dickinson and Company) 4 Jan 2011

MGH, Veridex establish research center of excellence on circulating tumor cell technologies

Massachusetts General Hospital (MGH) has entered into a collaborative agreement with Veridex LLC to establish a center of excellence in research on circulating tumor cell (CTC) technologies. The overall goal of the agreement is to develop and commercialize novel technologies for capturing and characterizing CTCs, solid tumor cells found at extremely low levels in the bloodstream, which may offer a key to noninvasive characterization of cancer and potentially to early detection.

4 Jan 2011

New technology can help implement safe driving strategies in electric wheelchairs

Thick gravel, mud, snow, steep ramps or hills . . . They might get a pedestrian a little dirty or out of breath, but to someone in an electric wheelchair, they could mean terrain that's simply too difficult to cross alone. To address this problem, researchers at the Florida A&M University-Florida State University College of Engineering are working on technology that will enable electric-powered wheelchairs to detect hazardous terrain and automatically adjust their control settings to maneuver more safely.

4 Jan 2011

18F-FDG PET scans help evaluate cognitive dysfunction of pediatric fever-induced epilepsy

Sudden, catastrophic childhood epilepsy is a parent's worst nightmare, especially in the case of fever-induced refractory epileptic encephalopathy in school-age children (FIRES). While not much is known about the condition, new research published in the January issue of The Journal of Nuclear Medicine shows that positron emission tomography (PET) scans can offer an evaluation of cognitive dysfunction of FIRES, its evolution and further prognosis.

4 Jan 2011

U-M research shows children are more frequently exposed to radiation through imaging tests

Children frequently exposed to medical imaging procedures that utilize radiation, U-M research shows. "Our findings indicate that more awareness about the frequent use of these tests may be needed among care providers, hospitals and parents," says Adam L. Dorfman, M.D., clinical assistant professor of pediatrics and communicable diseases and of radiology at the U-M Medical School.

4 Jan 2011

Pandemic flu toolkit for nursing facilities

A complimentary planning tool is now available to help the nation's nursing homes prepare for an influenza pandemic. The new resource is courtesy of the New Jersey Hospital Association, with grant funding from Hoffman-LaRoche.

4 Jan 2011

Florida public hospitals a likely target for new governor; Two people appointed to create Calif. health exchange

Florida's government-owned hospitals will be in the political cross hairs after Tuesday's inauguration of Rick Scott, once leader of the nation's largest for-profit hospital chain. The governor-elect's transition team has recommended creation of a panel to study whether government-owned hospitals -- Miami-Dade's Jackson Health System and Broward's two hospital districts among them -- are necessary (Dorschner, 1/2).

4 Jan 2011

Cyfluent Chart, Version 2.0 receives Complete EHR certification

Cyfluent, Inc. announced today that Cyfluent Chart, Version 2.0, is 2011/2012 compliant and was certified as a Complete EHR on Friday, November 12, 2010 by the Certification Commission for Health Information Technology (CCHIT®), an ONC-ATCB, in accordance with the certification criteria adopted by the Secretary of Health and Human Services. The 2011/2012 criteria support the Stage 1 meaningful use measures required to qualify eligible providers and hospitals for funding under the American Recovery and Reinvestment Act (ARRA).

3 Jan 2011

Saint John's Health System and St.Vincent Jennings parter with Indiana Health Information Exchange

Joining a network that includes 19,000 physicians and over 80 hospitals, long-term care facilities and other healthcare organizations, Saint John's Health System and St.Vincent Jennings Hospitals are now part of the Indiana Health Information Exchange (IHIE). The two hospitals are now connected through their participation in IHIE's DOCS4DOCS ® Service.

3 Jan 2011

SAIC awarded NIH follow-on task order to provide support to Center for Scientific Review

Science Applications International Corporation (SAIC) announced today its was awarded a follow-on task order by the National Institutes of Health to provide software and technical support to the Center for Scientific Review (CSR). The indefinite-delivery/indefinite-quantity task order has a six month base period of performance, 9 six-month options and a total contract ceiling of more than $24 million if all options are exercised. Work will be performed in Bethesda, Md. The task order was awarded under NIH's Chief Information Officer-Solutions and Partners (CIO-SP2) contract.

3 Jan 2011

Celera seeks FDA premarketing approval for KIF6 Genotyping Assay

Celera Corporation today announced that it has submitted a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for its KIF6 Genotyping Assay, a new molecular In Vitro diagnostic (IVD) test designed to detect a marker for risk of coronary heart disease (CHD) independent of traditional risk factors and aid clinical evaluation when statin treatment is being considered.

3 Jan 2011

Innovative approach in revision plastic surgery

Corrective cosmetic surgery cases are definitely on the rise. In fact, revision plastic surgery comprises nearly half of the patients Dr. Sam Rizk, Manhattan Facial Plastic Surgeon treats in his Park Avenue practice. From windblown tight facelifts to ski slope shaped, pointy noses, Dr. Rizk has fixed them all. He believes in a natural looking approach when it comes to doing any facial plastic surgery. Dr. Rizk knows that every nose is as unique as every patient's face is different.

3 Jan 2011

URAC releases Patient Centered Health Care Home Program Toolkit

URAC, a leading health care accreditation and education organization, announces the release of its Patient Centered Health Care Home Program Toolkit. This new program provides an educational, step-wise, self-paced approach to guide health care practices, and sponsoring health plans, insurers, and pilot programs, on how practices can transform themselves into a patient centered health care home.

30 Dec 2010

AngioScore initiates worldwide recall of AngioSculpt PTA Scoring Balloon Catheter

On November 15, 2010 AngioScore Incorporated initiated a worldwide recall of the AngioSculpt® PTA Scoring Balloon Catheter, 0.018" OTW, balloon sizes: 4.0x20mm, 5.0x20mm, and 6.0x20mm. This recall was initiated because of a small number of reports from the field of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element, wherein the proximal end of the scoring element remains secured to the catheter.

30 Dec 2010

Clinical Data closes sale of genetic, pharmacogenomic testing and biomarker development business

Clinical Data, Inc. today announced that the Company has closed the sale of its genetic and pharmacogenomic testing and biomarker development business to Transgenomic, Inc. for $15.5 million. The sale completes Clinical Data's transformation into a pharmaceutical company with a deep product pipeline, including two promising late-stage compounds, the most advanced of which is vilazodone, a new treatment in development for Major Depressive Disorder.

30 Dec 2010

Experimental device for obstructive sleep apnea

Obstructive sleep apnea, a dangerous sleep disorder that affects millions of Americans may have found a cure. The disease commonly manifested as snoring but leading to tremendous sleep deprivation can be severely debilitating. Sleep deprivation may lead to car crashes, accidents, high blood pressure, heart attack, stroke, and diabetes.

29 Dec 2010

Crothall partners with 3M to implement effective infection control

Crothall Healthcare, a premier provider of support services to healthcare clients, announced its Preferred Partnership arrangement with 3M to kick-off its powerfully enhanced approach to infection control.

29 Dec 2010

Researchers develop breath-analysis technology for rapid detection of biomarkers

Researchers have overcome a fundamental obstacle in developing breath-analysis technology to rapidly diagnose patients by detecting chemical compounds called "biomarkers" in a person's respiration in real time.

29 Dec 2010

Natus Medical ships ALGO hearing screeners to New South Wales

Natus Medical Incorporated today announced that it was awarded, and has shipped, a $1.3 million order for its ALGO hearing screeners from New South Wales, Australia's most populous state.

29 Dec 2010

HeartWare seeks FDA PMA approval for HeartWare Ventricular Assist System

HeartWare International, Inc. today announced that it has submitted a Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the HeartWare® Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure.

28 Dec 2010

Device / Technology News

FDA clears first automated molecular tests to diagnose and differentiate HSV infection

MGH, Veridex establish research center of excellence on circulating tumor cell technologies

New technology can help implement safe driving strategies in electric wheelchairs

18F-FDG PET scans help evaluate cognitive dysfunction of pediatric fever-induced epilepsy

U-M research shows children are more frequently exposed to radiation through imaging tests

Pandemic flu toolkit for nursing facilities

Florida public hospitals a likely target for new governor; Two people appointed to create Calif. health exchange

Cyfluent Chart, Version 2.0 receives Complete EHR certification

Saint John's Health System and St.Vincent Jennings parter with Indiana Health Information Exchange

SAIC awarded NIH follow-on task order to provide support to Center for Scientific Review

Celera seeks FDA premarketing approval for KIF6 Genotyping Assay

Innovative approach in revision plastic surgery

URAC releases Patient Centered Health Care Home Program Toolkit

AngioScore initiates worldwide recall of AngioSculpt PTA Scoring Balloon Catheter

Clinical Data closes sale of genetic, pharmacogenomic testing and biomarker development business

Experimental device for obstructive sleep apnea

Crothall partners with 3M to implement effective infection control

Researchers develop breath-analysis technology for rapid detection of biomarkers

Natus Medical ships ALGO hearing screeners to New South Wales

HeartWare seeks FDA PMA approval for HeartWare Ventricular Assist System

Todd Bauman and Chris Povich

Scaling organ‑chip technology for human‑relevant drug discovery

Unlocking drug amorphization: Continuous, solvent-free twin screw granulation

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