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FDA approves Endologix's expanded Powerlink stent graft product line

Endologix, Inc., developer of minimally invasive treatments for aortic disorders, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its expanded offering of Powerlink® stent graft products. The approval covers 31 new sizes of Powerlink® main body bifurcated, proximal extension, and limb extension stent grafts that increase the system's addressable patient population by 5% to 10%.

10 Jun 2010

WaferGen announces microRNA, oncology gene panels for SmartChip Real-Time PCR System

WaferGen Biosystems, Inc., a leading developer of state-of-the-art genetic analysis systems, today announced the availability of two gene expression profiling panels for the SmartChip Real-Time PCR System that will enable microRNA and cancer pathway profiling capability.

10 Jun 2010

Formedix's design tools integrated with Nextrials' EDC and clinical trial data management platform

Nextrials, Inc., a leader in clinical research software and services, today announced that its electronic data capture (EDC) and clinical trial data management platform, Prism™, is now integrated with the study design tools offered by Formedix. Formedix's industry leading Origin™ products include database design tools based on the data standards developed by the Clinical Data Interchange Standards Consortium (CDISC), a platform that Nextrials fully supports.

10 Jun 2010

BMEYE receives European Red Herring Top 100 Award

BMEYE B.V., the innovator of combined noninvasive, beat-to-beat blood pressure and cardiac output monitoring received the prestigious European Red Herring Top 100 Award 2010. Red Herring's Top 100 Europe list has become a mark of distinction for identifying promising new companies and entrepreneurs.

10 Jun 2010

Actelion Pharmaceuticals announces availability of PAH Mobile Reference Guide

Actelion Pharmaceuticals US, Inc. is announcing the availability of the Pulmonary Arterial Hypertension Mobile Reference Guide, the first multimedia smart phone application that provides information on PAH disease, pathology, diagnosis, and treatment guidelines to healthcare professionals.

10 Jun 2010

22 Midwest facilities named Centers of Excellence in accelerated partial breast irradiation

Twenty-two facilities in the Midwest have been named Centers of Excellence in accelerated partial breast irradiation (APBI) for their use of the SAVI® applicator, an advanced therapy for breast cancer as part of breast conservation therapy. The SAVI applicator can provide important advantages for women with early-stage breast cancer.

10 Jun 2010

Researchers develop new computer program for early diagnosis of Alzheimer's disease

Researchers of the University of Granada have developed a new computer program that allows early diagnosis of Alzheimer's disease through processed images. This new system has enhanced successful early diagnosis of Alzheimer's disease up to 90%, which is an important progress within this area of study.

10 Jun 2010

Boston Scientific's TAXUS Element Paclitaxel-Eluting Coronary Stent System launched in Europe

Boston Scientific Corporation today announced the market launch and first implants of its TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System in the European Union and other CE Mark countries. The TAXUS Element Stent System is the Company's third-generation drug-eluting stent (DES) technology and incorporates a platinum chromium alloy with an innovative stent design and an advanced catheter delivery system. It received CE Mark approval last month, which included a specific indication for the treatment of diabetic patients.

10 Jun 2010

StemCells' GS2-M cell culture media formulation enhances pluripotency of human ES, iPS cells

StemCells, Inc. announced today that newly published independent research demonstrates that its GS2-M cell culture media formulation enhances the pluripotency of human embryonic stem and induced pluripotent stem cells. The Company's GS2-M medium has already been shown to enable the derivation and long-term maintenance of mouse iPS cells.

10 Jun 2010

NanoString Technologies launches new solution to detect CNVs in human genomic samples

NanoString Technologies, Inc., a privately held life sciences company marketing a complete solution for detecting and counting large sets of target molecules in biological samples, today announced the launch of its early access program for a unique new solution that detects copy number variation in human genomic samples. The program was announced in conjunction with the company's participation in the European Human Genetics Conference in Gothenburg, Sweden.

From NanoString Technologies 10 Jun 2010

Nativis awarded patents in Japan, China, India for drug signal technology

Nativis, Inc., a La Jolla, Calif.-based life science company, has been issued patents in Japan, China and India for its innovative technology that captures the unique signals of approved drugs at the atomic level and then delivers the signal in a solution to treat serious illnesses. The technology, which also has U.S., Canadian and Australian patents, promises to transform the treatment of diseases, including those for which there are no known cures, such as brain cancer.

10 Jun 2010

MicroConstants adds second Waters Xevo TQ MS system

MicroConstants, Inc., a bioanalytical and pharmacokinetic-specialty Contract Research Organization (CRO) in San Diego, California, announces the continued expansion of its bioanalytical capacity through the addition of a second Waters Xevo TQ MS system. The CRO has also appointed a new East Coast business development manager to actively pursue new business opportunities in that region.

10 Jun 2010

Clarient becomes preferred genetic testing lab for Generation Health

Clarient, Inc., a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced a new contractual agreement with Generation Health, Inc. (GH). This agreement makes Clarient a preferred genetic testing lab for GH, thereby ensuring reimbursement of diagnostic tests done for GH's nationwide network of payor clients and expanding Clarient's potential market. GH is a genetic benefit management company partially-owned by CVS Caremark, the nation's largest pharmacy healthcare provider.

10 Jun 2010

Spectrum Dynamics commences ultra low dose trials of radiopharmaceutical agents with D-SPECT technology

Cardiovascular imaging accounts for 30 percent of all the radiation patients receive in the U.S. and today, at the Society for Nuclear Medicine annual meeting, Spectrum Dynamics announced it has begun clinical studies to show that its D-SPECT™ technology can accommodate significantly lower doses of radiopharmaceutical agents so the total radiation exposure to patients and staff is much lower compared to conventional cardiac imaging.

10 Jun 2010

Lantheus presents preliminary Phase 2 data of flurpiridaz F18 injection PET MPI at 57th SNM

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced preliminary Phase 2 data describing the methodology used to define an imaging protocol for a one-day rest-stress myocardial perfusion imaging test using its novel investigational PET imaging agent flurpiridaz F 18 injection (formerly known as BMS747158).

10 Jun 2010

ICON launches ICOLabs Medical Review Application

ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the launch of the ICOLabs Medical Review Application an innovative web based laboratory application that enables more efficient use of medical monitoring time.

10 Jun 2010

DermaGenoma releases CelluliteDX Genetic Test for women

As summer swimsuit season heats up, women around the world will inspect their looks in the mirror. A majority of them will see cellulite - at some point - but a new genetic test may be able to help them avoid cellulite before anyone notices.

10 Jun 2010

MonoSol Rx, APR expand film formulation development collaboration

MonoSol Rx, the developer of PharmFilm® technology and a drug delivery company specializing in proprietary pharmaceutical film products, and APR Applied Pharma Research s.a. ("APR") announced today an expansion of their relationship to identify and develop film formulations of prescription drug products beyond ondansetron and donepezil to include zolmitriptan. Zolmitriptan is currently commercially available for the acute treatment of migraine headache in adults, and facing initial patent expirations in 2012.

10 Jun 2010

Driving while distracted is equivalent to drunken driving

It's time for physicians to talk to patients about driving while distracted, a problem that has risen to the rough equivalence of drunken driving thanks to the proliferation of phones that allow drivers to talk and text, Amy Ship, MD, a primary care physician at Beth Israel Deaconess Medical Center suggests.

10 Jun 2010

SGS announces total package testing solution for medical device, pharma product manufacturers

SGS Consumer Testing Services today announced an expansion of its package testing services with a global program to ensure packaging integrity for medical devices and pharmaceutical products. The program – announced at this week's EastPack 2010 conference in New York - offers one-stop testing of product containers, secondary packaging and transit packaging to evaluate the product protection capabilities, durability and environmental sustainability of all package components.

10 Jun 2010

Device / Technology News

FDA approves Endologix's expanded Powerlink stent graft product line

WaferGen announces microRNA, oncology gene panels for SmartChip Real-Time PCR System

Formedix's design tools integrated with Nextrials' EDC and clinical trial data management platform

BMEYE receives European Red Herring Top 100 Award

Actelion Pharmaceuticals announces availability of PAH Mobile Reference Guide

22 Midwest facilities named Centers of Excellence in accelerated partial breast irradiation

Researchers develop new computer program for early diagnosis of Alzheimer's disease

Boston Scientific's TAXUS Element Paclitaxel-Eluting Coronary Stent System launched in Europe

StemCells' GS2-M cell culture media formulation enhances pluripotency of human ES, iPS cells

NanoString Technologies launches new solution to detect CNVs in human genomic samples

Nativis awarded patents in Japan, China, India for drug signal technology

MicroConstants adds second Waters Xevo TQ MS system

Clarient becomes preferred genetic testing lab for Generation Health

Spectrum Dynamics commences ultra low dose trials of radiopharmaceutical agents with D-SPECT technology

Lantheus presents preliminary Phase 2 data of flurpiridaz F18 injection PET MPI at 57th SNM

ICON launches ICOLabs Medical Review Application

DermaGenoma releases CelluliteDX Genetic Test for women

MonoSol Rx, APR expand film formulation development collaboration

Driving while distracted is equivalent to drunken driving

SGS announces total package testing solution for medical device, pharma product manufacturers

Redefining control and consistency in anaerobic microbiome workflows

AI in Healthcare: How generative tools are transforming clinical practice

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

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