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HeartWare's ADVANCE bridge-to-transplant clinical trial: FDA approves additional enrollment under CAP

HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration has approved an IDE Supplement that allows HeartWare to enroll up to an additional 54 patients in its "ADVANCE" bridge-to-transplant clinical trial under a Continued Access Protocol (CAP).

8 Apr 2010

University of Minnesota-Twin Cities recognizes Rich Nazarian with 2010 DMD Conference Award

Rich Nazarian, Minnetronix, Inc. President and CEO, will be recognized for his dedication to the medical device community by the University of Minnesota-Twin Cities with the honor of the 2010 Design of Medical Devices Conference Award.

8 Apr 2010

Intelligent Hospital Systems validates usage of ICU Medical's ChemoCLAVE Bag Spike with RIVA

IV Automation is becoming an increasingly comprehensive technology after medical device company Intelligent Hospital Systems validated ICU Medical Inc.'s ChemoCLAVE Bag Spike for use with RIVA (Robotic IV Automation System) - a self-contained unit for filling IV syringes and bags.

8 Apr 2010

Researchers: VA electronic health records system worth the cost

A new study in the journal Health Affairs finds that while the system, "collectively called Vista, for Veterans Health Information Systems and Technology Architecture" was expensive, it has paid off, The Wall Street Journal reports.

8 Apr 2010

Encouraging results from OptiNose's sumatriptan Phase II study for migraine

OptiNose, a leader in nasal drug delivery systems, is pleased to announce the publication in Cephalalgia of results from its Phase II clinical study investigating the efficacy and tolerability of its novel, intranasal drug/device product for the treatment of migraine.

8 Apr 2010

Innovative algorithms lead to new arena of breast ultrasound technology

The groundbreaking algorithms developed at TechniScan, Inc. have led to a new arena of whole breast ultrasound technology, as presented at a national medical ultrasound conference in San Diego in March.

8 Apr 2010

Oraya Therapeutics' IRay stereotactic radiotherapy system granted European CE Mark approval

Oraya Therapeutics, Inc. announces today that a leading European notified body has granted approval to designate the CE mark to Oraya's IRayTM stereotactic radiotherapy system. Under development since 2007, the IRay is designed specifically to treat diseases of the eye, and the technology enables precise delivery of low energy X-rays for the treatment of wet age-related macular degeneration (AMD).

8 Apr 2010

Ultrasound scan of carotid artery improves prediction of heart disease: Research

New research shows that doing a simple ultrasound scan of the carotid artery significantly improves the prediction of heart disease, giving doctors a better clue of who is at high risk for a heart attack.

8 Apr 2010

New Life MicroFab Division launched to provide micro-fabrication services

Life BioScience, Inc. has launched a new Life MicroFab™ Division that provides a broad range of micro-fabrication services for devices made in APEX Glass, APEX Ceramic, Silicon, Pyrex, SOI, Kapton and other standard materials used in the semiconductor manufacturing process.

8 Apr 2010

BIOTRONIK receives European approval for new ProMRI Pacing Systems

BIOTRONIK, a leading manufacturer of implantable cardiac devices and pioneer of wireless remote monitoring technologies, announced today the European approval of its new ProMRI Pacing Systems — Evia pacemaker series and Safio S pacing leads — providing European patients the first portfolio of bradycardia systems that are compatible with Magnetic Resonance Imaging (MRI) scans under specific conditions.

8 Apr 2010

Baxa releases DoseEdge TPN for automated TPN production

Baxa Corporation, a leading provider of medical devices and systems that automate pharmacy operations and increase patient safety, today announced the release of DoseEdge TPN, the industry's first product for completely managing the workflow for automated TPN production.

8 Apr 2010

Torax Medical's LINX Anti-Reflux treatment receives CE Mark approval

Torax Medical Inc., a medical device company focused on the minimally invasive treatment of gastro-esophageal reflux disease (GERD), has received CE Mark for its LINX® Anti-Reflux treatment. The company has started commercial launch of the LINX device at select centers in Europe.

8 Apr 2010

ASPIRE 2010 focuses on A.R.T. issues

Infertility, defined as the failure to conceive after 12 months or more of regular, unprotected intercourse, may affect as many as 15 percent of couples around the world including Asia. Like other countries, China's infertility rate is on the rise increasing from 3 percent to 15 percent in the past 20 years. It is estimated that at least 40 million Chinese couples have difficulty in having children or are actually infertile.

7 Apr 2010

Updates from Phase I/IIa clinical trial of DIABECELL treatment in insulin-dependent diabetics

Living Cell Technologies Limited, a global company pioneering the development of a cell implant to treat diabetes, today provided a penultimate update regarding the three-year follow up of its Phase I/IIa clinical trial in Russia of its DIABECELL® treatment in insulin-dependent diabetics.

7 Apr 2010

East Orange General Hospital to implement Streamline Health's document workflow solutions

Streamline Health Solutions, Inc. a leading provider of document workflow solutions for hospitals, today announced that East Orange General Hospital in East Orange, N.J., will implement Streamline Health's document workflow solutions integrated with GE Centricity® Enterprise clinical information solution. Through this integrated solution, East Orange General Hospital looks to enhance their health information management processes, boost productivity and ultimately, improve patient care.

7 Apr 2010

Cepheid to launch GeneXpert Infinity-48 in Europe at 20th ECCMID

Cepheid will initiate European launch of its newest addition to the GeneXpert® family of molecular diagnostic testing systems, the GeneXpert Infinity-48, at the 20th annual European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Vienna, Austria. The GeneXpert Infinity-48 System is the world's first and only fully-automated, random-access system designed for management of the entire molecular testing workflow — from sample data, cartridge loading and unloading, to final reporting of test results and disposal of cartridges.

7 Apr 2010

HRV devices reduce respiratory symptoms in children: Study

Houses today are so well sealed that they can trap humidity and pollutants indoors as a result of insufficient ventilation. Recently, a team of Canadian scientists led by Dr. Tom Kovesi, a pediatric respirologist at the Children's Hospital of Eastern Ontario in Ottawa, Canada, performed a randomized double-blind, placebo controlled trial to determine whether use of heat recovery ventilators would increase home ventilation and therefore reduce the risk of lower respiratory tract illness in young children.

7 Apr 2010

Study demonstrates potential ability of Chronix serum DNA assays in diagnosis of breast cancer

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 (MS). 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.

7 Apr 2010

Illumina launches VeraCode ADME Core Panel

Illumina, Inc. today announced the launch of its VeraCode ADME Core Panel designed to help researchers study genetic predispositions for differential drug response and adverse events. The VeraCode ADME Core Panel offers the most complete representation of the key biomarkers associated with drug absorption, distribution, metabolism and excretion (ADME) as standardized by pharmaceutical industry experts in the PharmADME Core List.

From Illumina, Inc. 7 Apr 2010

Health Robotics introduces Virtual High-Availability Architecture for CytoCare and i.v.STATION robots

As part of its I.V. Room of the Future initiative to cooperate with other industry leaders, Health Robotics today announced the immediate availability of its revolutionary Virtual High-Availability Architecture (up to 99.99%), including state-of-the-art, virtualization compliant, cluster and fail-over, disaster recovery, and back-up solutions for its CytoCare and i.v.STATION robots [with future expansion to TPNstation when available], and its i.v.SOFT Workflow Engine for manual compounding.

7 Apr 2010

Device / Technology News

HeartWare's ADVANCE bridge-to-transplant clinical trial: FDA approves additional enrollment under CAP

University of Minnesota-Twin Cities recognizes Rich Nazarian with 2010 DMD Conference Award

Intelligent Hospital Systems validates usage of ICU Medical's ChemoCLAVE Bag Spike with RIVA

Researchers: VA electronic health records system worth the cost

Encouraging results from OptiNose's sumatriptan Phase II study for migraine

Innovative algorithms lead to new arena of breast ultrasound technology

Oraya Therapeutics' IRay stereotactic radiotherapy system granted European CE Mark approval

Ultrasound scan of carotid artery improves prediction of heart disease: Research

New Life MicroFab Division launched to provide micro-fabrication services

BIOTRONIK receives European approval for new ProMRI Pacing Systems

Baxa releases DoseEdge TPN for automated TPN production

Torax Medical's LINX Anti-Reflux treatment receives CE Mark approval

ASPIRE 2010 focuses on A.R.T. issues

Updates from Phase I/IIa clinical trial of DIABECELL treatment in insulin-dependent diabetics

East Orange General Hospital to implement Streamline Health's document workflow solutions

Cepheid to launch GeneXpert Infinity-48 in Europe at 20th ECCMID

HRV devices reduce respiratory symptoms in children: Study

Study demonstrates potential ability of Chronix serum DNA assays in diagnosis of breast cancer

Illumina launches VeraCode ADME Core Panel

Health Robotics introduces Virtual High-Availability Architecture for CytoCare and i.v.STATION robots

How can super-resolution technology help study neurotransmission?

The Proteoform Puzzle: Unlocking the Next Frontier

Synthetic Biology and the Pursuit of Living Diagnostics

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