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FDA issues warning letters to five electronic cigarette distributors

The U.S. Food and Drug Administration today issued warning letters to five distributors for various violations of the Federal Food, Drug, and Cosmetic Act (FDCA) including unsubstantiated claims and poor manufacturing practices.

10 Sep 2010

PediaWorks, Medikit form PediaCath to develop pediatric catheters

PediaWorks and Medikit Co., Ltd. announced the formation of PediaCath, Inc., a joint venture to help alleviate the severe shortage of medical devices for use in pediatric patients.

10 Sep 2010

Avinger initiates enrollment in Wildcat Catheter trial for chronic total occlusions in femoropopliteal lesions

Avinger, Inc., a medical device company focused on the development of innovative devices to combat peripheral artery disease, announces the enrollment of the first patient in the CONNECT (Chronic TOtal OcclusioN CrossiNg with thE WildCat CatheTer) clinical trial. The CONNECT trial is a prospective, multi-center, non-randomized study intended to evaluate the Wildcat Catheter's ability to cross chronic total occlusions in femoropopliteal lesions.

10 Sep 2010

Researchers to develop image analysis techniques for melanoma classification

Melanoma, the most serious form of skin cancer varies in size, shape and severity, and although pathologists and researchers often intuitively differentiate between types of melanomas, the variations have never been formally quantified and documented. A project involving RENCI and researchers in the University of North Carolina School of Medicine and the departments of computer science and statistics and operations research aims to change that by using image analysis techniques to improve melanoma classification.

10 Sep 2010

Specific feedback signals from fMRI controls brain regions: Study

There is new evidence that people can learn to control the activity of some brain regions when they get feedback signals provided by functional magnetic resonance brain imaging (fMRI).

10 Sep 2010

Researchers to develop two-way fiber optic communication between prosthetic limbs and peripheral nerves

Lightning fast connections between robotic limbs and the human brain may be within reach for injured soldiers and other amputees with the establishment of a multimillion-dollar research center led by SMU engineers.

10 Sep 2010

ECRI Institute PSO launches Patient Safety E-lerts to reduce healthcare events' risk

In response to adverse event reports received by ECRI Institute PSO and to promote such learning, ECRI Institute PSO has begun disseminating periodic Patient Safety E-lerts to participating organizations. The Patient Safety E-lert will bring attention to these issues and is concisely formatted to stimulate discussion and action by interdisciplinary committees focused on reducing the risk of healthcare events.

10 Sep 2010

FDA approves Abreu BTT 700 System for temperature monitoring

Brain Tunnelgenix Technologies Corp. announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance to market its Abreu BTT 700 System for continuous temperature monitoring.

10 Sep 2010

PracticeMax acquires Medinomics, expands healthcare and technology expertise

PracticeMax, a provider of revenue cycle management and software services, today announced it has acquired Medinomics, of Shreveport, La., expanding the operations and geographical footprint of PracticeMax throughout the southern United States.

10 Sep 2010

Microvisk secures £2.5 million to develop world’s first medical diagnostic SmartStrip®

Microvisk Technologies, the developer of a handheld system to monitor the blood clotting status of patients taking the drug Warfarin, has raised £2.5 million through a rights issue to existing investors. The round was significantly oversubscribed and completed within four weeks.

9 Sep 2010

Roche announces Ambry Genetics as first US CSP for NimbleGen SeqCap EZ Exome workflow

Roche NimbleGen announces that Southern California (Aliso Viejo) based genomic services provider Ambry Genetics has officially become a Certified Service Provider (CSP) for the NimbleGen SeqCap EZ Exome workflow. They will provide target-enrichment services using NimbleGen SeqCap EZ Human Exome coupled with next-generation sequencing services for genetic research.

9 Sep 2010

Affinity Health System selects GE Centricity EMR for patient care network

Northeast Wisconsin's nationally recognized Affinity Health System is the latest to choose GE Centricity® EMR for its patient care network. The Catholic, mission-oriented, regional health network is a collaboration between the Fox Valley's Ministry Health Care and Wheaton Franciscan Healthcare and plans to implement Centricity EMR across its 22 multi-specialty clinics in 14 communities to help care for an average of 21,000 patients each year.

9 Sep 2010

Caliper launches toolkit for direct co-registration of images from multiple preclinical imaging modalities

Caliper Life Sciences, Inc., a leading provider of tools and services for drug discovery, life sciences research and molecular diagnostics, today introduced software and accessory items to enable the direct co-registration of images from multiple preclinical imaging modalities.

9 Sep 2010

Liquent reveals new solution branding positioning

Liquent Inc., the global leader in regulatory information management solutions and services, revealed today its new solution branding positioning. The announcement comes approximately three months following the merger of the Liquent and Datafarm organizations announced June 1, 2010.

9 Sep 2010

Aethlon Hemopurifier captures immunosuppressive exosomes from individuals with metastatic melanoma.

Aethlon Medical, Inc., the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that its researchers have demonstrated the ability of the Aethlon Hemopurifier® to capture immunosuppressive exosomes derived from individuals with metastatic melanoma.

9 Sep 2010

ESC recommends InspireMD MGuard mesh technology for thrombotic lesions

InspireMD Ltd., a medical device company engaged in the development and commercialization of the mesh based MGuard(TM) stent systems, is proud to report that mesh-based protection, is now recommended for use in the new Guidelines of the Task force of Myocardial Revascularization of the European Society of Cardiology (ESC). According to the latest European Society of Cardiology Guidelines, published at the ESC Congress last week, "Mesh-based protection may be considered for PCI of highly thrombotic or SVG lesions" - it has received a class IIb recommendation.

9 Sep 2010

Salumatics to resell HealthAsyst patient self-service kiosks in Canada

Salumatics Inc. and HealthAsyst Pvt Ltd today announce a strategic partnership agreement in which Salumatics will be a value-added reseller of the HealthAsyst patient self-service kiosks in Canada. As part of this agreement Salumatics will leverage their local presence and industry expertise to market the kiosks and provide technical support to Canadian customers.

9 Sep 2010

Stereotaxis highlights clinical outcomes of Niobe Magnetic Navigation System in VT ablation

Stereotaxis, Inc. highlighted significant new additions to the body of evidence demonstrating exceptional clinical outcomes achieved with its Niobe® Magnetic Navigation System in ventricular tachycardia ablation.

9 Sep 2010

WHO forum to review developing country access to life-saving medical devices

More than 350 leading health experts from over 100 countries meet today at a World Health Organization (WHO) forum in Bangkok, Thailand to review new evidence and agree ways to improve developing country access to life-saving medical devices.

9 Sep 2010

EMRs aid study of genetic variants influencing human susceptibility to peripheral arterial disease

Scientific research published in the current issue of the Journal of the American Medical Informatics Association (JAMIA) reports on a study of genetic variants that influence human susceptibility to peripheral arterial disease (PAD), made possible by leveraging electronic medical records (EMRs; also called EHRs or electronic health records).

9 Sep 2010

Device / Technology News

FDA issues warning letters to five electronic cigarette distributors

PediaWorks, Medikit form PediaCath to develop pediatric catheters

Avinger initiates enrollment in Wildcat Catheter trial for chronic total occlusions in femoropopliteal lesions

Researchers to develop image analysis techniques for melanoma classification

Specific feedback signals from fMRI controls brain regions: Study

Researchers to develop two-way fiber optic communication between prosthetic limbs and peripheral nerves

ECRI Institute PSO launches Patient Safety E-lerts to reduce healthcare events' risk

FDA approves Abreu BTT 700 System for temperature monitoring

PracticeMax acquires Medinomics, expands healthcare and technology expertise

Microvisk secures £2.5 million to develop world’s first medical diagnostic SmartStrip®

Roche announces Ambry Genetics as first US CSP for NimbleGen SeqCap EZ Exome workflow

Affinity Health System selects GE Centricity EMR for patient care network

Caliper launches toolkit for direct co-registration of images from multiple preclinical imaging modalities

Liquent reveals new solution branding positioning

Aethlon Hemopurifier captures immunosuppressive exosomes from individuals with metastatic melanoma.

ESC recommends InspireMD MGuard mesh technology for thrombotic lesions

Salumatics to resell HealthAsyst patient self-service kiosks in Canada

Stereotaxis highlights clinical outcomes of Niobe Magnetic Navigation System in VT ablation

WHO forum to review developing country access to life-saving medical devices

EMRs aid study of genetic variants influencing human susceptibility to peripheral arterial disease

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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