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Medtronic recieves conditional approval from FDA to modify CoreValve U.S. Pivotal Clinical Trial

Medtronic, today announced it has received conditional approval from the U.S. Food and Drug Administration to modify its CoreValve U.S. Pivotal Clinical Trial.

19 Jan 2011

Study highlights utility of CDS for diagnosing major depression

In the last 2010 issue of Psychotherapy and Psychosomatics, a new scale for measuring depression in cardiac patients is presented. The Cardiac Depression Scale was initially developed specifically for cardiac patients. Its purpose is to allow measurement over the continuum between low-level depressive symptomatology and major depression.

19 Jan 2011

PAM50 test is now available to classify breast cancer subtypes

ARUP Laboratories, a leading national clinical and anatomic pathology reference laboratory and a leader in innovative laboratory research and development, today announced the availability of a new laboratory developed test designed to classify breast cancer into clinically significant molecular subtypes that are important for the management of the disease.

18 Jan 2011

BSD Medical sells MicroThermX Microwave System to Med-Italia Biomedica

BSD Medical Corporation, a leading provider of medical systems that utilize heat therapy to treat cancer, today announced the sale and shipment of the MicroThermX Microwave System to Med-Italia Biomedica (Med-Italia), one of the largest interventional radiology/oncology distributors in Italy.

18 Jan 2011

GE Healthcare becomes US distributor and reseller of Veran's ig4 navigation system

GE Healthcare and Veran, a provider of proprietary 4D registration capability for precise targeting of lesions via its FDA cleared platform, today announced a strategic supplier agreement in which GE Healthcare becomes the exclusive distributor and reseller of Veran's ig4 navigation system in the United States.

18 Jan 2011

SurgiCount Safety-Sponge System helps eliminate occurrence of retained surgical sponges: Study

Results of a multi-year, independent clinical research study on retained surgical sponges published in the February edition of The Joint Commission Journal on Quality and Patient Safety show that the institution implementing the SurgiCount Safety-Sponge® System eliminated the occurrence of retained surgical sponges and the costs associated with these preventable surgical errors.

18 Jan 2011

FDA approves Cook Medical's two Formula renal stents

Cook Medical has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its Formula™ Balloon-Expandable Renal Stent System. The approval includes both the Formula 414RX Balloon Expandable Renal Stent and the Formula 418 Balloon Expandable Renal Stent.

18 Jan 2011

Aegis releases Discoverant 4.0 manufacturing intelligence software

Aegis Analytical Corp., the leading provider of Enterprise Manufacturing and Process Intelligence software, announced today the availability of Aegis Discoverant® 4.0, the latest version of its global software platform.

18 Jan 2011

PositiveID and RFID Solutions complete development of temperature-sensing microchip

PositiveID Corporation announced today that it has completed the development of its temperature-sensing microchip in conjunction with development partner RFID Solutions of Malaga, Spain. The microchip, which uses radio frequency identification (RFID) technology, is able to measure internal temperature within the body and communicate that temperature wirelessly to an external reader.

18 Jan 2011

Healthcare Information Xchange of New York completes implementation of InterSystems HealthShare HIE platform

InterSystems Corporation, the global leader in software for connected health care, today announced that the Healthcare Information Xchange of New York (HIXNY) has completed implementation of InterSystems HealthShare™ as its core health information exchange (HIE) platform.

18 Jan 2011

Cardiac surgery market to reach over $4.4 billion by 2017

According to a new report by iData Research, the leading global authority in medical device and pharmaceutical market research, percutaneous aortic valve replacement (PAVR) and percutaneous mitral valve repair (PMVR) devices are expected to enter the U.S. market in 2011 and grow to almost $1.3 billion by 2017.

18 Jan 2011

FDA grants CASMED 510(k) clearance for expanded labeling of FORE-SIGHT Absolute Tissue Oximeter

CAS Medical Systems, Inc. today announced receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded labeling of its FORE-SIGHT® Absolute Tissue Oximeter to monitor skeletal muscle of infants, children and adolescents weighing between 5 and 50 kg.

18 Jan 2011

ONC awards Accenture healthcare IT interoperability contract

The Office of the National Coordinator for Health Information Technology (ONC) awarded Accenture a two-year contract to help identify the standards and specifications that facilitate the exchange of data across the evolving healthcare system.

18 Jan 2011

Positive results from Cook Medical's REFORM stent clinical trial for treatment of renal artery stenosis

Study investigators today reported initial data from Cook Medical's REFORM clinical trial that is aimed at assessing the safety and effectiveness of the company's balloon-expandable renal stent for the treatment of renal artery stenosis. The data, presented by Robert Bersin, M.D., at ISET 2011, reveal a nine-month primary patency rate of 89.5 percent and a 97 percent rate of successful delivery and deployment of the stent.

18 Jan 2011

Orchid Cellmark executes multi-year contract with U.K. Child Maintenance and Enforcement Commission

Orchid Cellmark, a leading worldwide provider of identity DNA testing services, today announced it has executed a multi-year contract with the U.K. Child Maintenance and Enforcement Commission (CMEC), formerly the Child Support Agency (CSA), for the exclusive provision of DNA paternity testing services. Orchid Cellmark delivers its paternity testing services in the U.K. under the Cellmark brand.

18 Jan 2011

Potential device to treat post-operative cognitive decline

It's called post-operative cognitive decline, a syndrome in which patients experience memory loss or other forms of cognitive dysfunction after surgery or critical illness.

18 Jan 2011

Critical Diagnostics' Presage ST2 Assay effectively risk-stratifies chronic heart failure patients

Critical Diagnostics, the exclusive developer of the Presage® ST2 Assay, announces the publication of the Penn Heart Failure Study (PHFS) in an advance e-publication of the January 19, 2010 edition of Circulation: Heart Failure. The results of this study demonstrated that ST2 levels not only predict outcomes for ambulatory outpatients with chronic heart failure, they more effectively risk-stratify such patients.

18 Jan 2011

eCareSoft's eCS receives Complete Inpatient EHR Certification

eCareSoft's eCS has received Complete Inpatient EHR Certification deeming the electronic health record (EHR) software capable of enabling hospitals and their affiliates to meet the Stage 1 meaningful use measures required to qualify for funding under the American Recovery and Reinvestment Act (ARRA).

18 Jan 2011

Hotspur announces successful completion of GPSCath Catheter in peripheral angioplasty surgery

Hotspur Technologies, announced today that Dr. Greg Sampognaro, Interventional Cardiologist at P & S Surgical Hospital in Monroe, Louisiana, successfully completed the first use of the GPSCath Balloon Dilatation Catheter in an intervention to treat a blocked peripheral artery.

18 Jan 2011

Palomar Medical introduces Artisan Aesthetic System to provide laser skin resurfacing treatment

Palomar Medical Technologies, a leading researcher and developer of lasers and pulsed-light systems for aesthetic treatments, is pleased to announce that the Artisan Aesthetic System is now being shipped.

18 Jan 2011

Device / Technology News

Medtronic recieves conditional approval from FDA to modify CoreValve U.S. Pivotal Clinical Trial

Study highlights utility of CDS for diagnosing major depression

PAM50 test is now available to classify breast cancer subtypes

BSD Medical sells MicroThermX Microwave System to Med-Italia Biomedica

GE Healthcare becomes US distributor and reseller of Veran's ig4 navigation system

SurgiCount Safety-Sponge System helps eliminate occurrence of retained surgical sponges: Study

FDA approves Cook Medical's two Formula renal stents

Aegis releases Discoverant 4.0 manufacturing intelligence software

PositiveID and RFID Solutions complete development of temperature-sensing microchip

Healthcare Information Xchange of New York completes implementation of InterSystems HealthShare HIE platform

Cardiac surgery market to reach over $4.4 billion by 2017

FDA grants CASMED 510(k) clearance for expanded labeling of FORE-SIGHT Absolute Tissue Oximeter

ONC awards Accenture healthcare IT interoperability contract

Positive results from Cook Medical's REFORM stent clinical trial for treatment of renal artery stenosis

Orchid Cellmark executes multi-year contract with U.K. Child Maintenance and Enforcement Commission

Potential device to treat post-operative cognitive decline

Critical Diagnostics' Presage ST2 Assay effectively risk-stratifies chronic heart failure patients

eCareSoft's eCS receives Complete Inpatient EHR Certification

Hotspur announces successful completion of GPSCath Catheter in peripheral angioplasty surgery

Palomar Medical introduces Artisan Aesthetic System to provide laser skin resurfacing treatment

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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