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Affymetrix to develop, commercialize Axiom Chinese myDesign Genotyping Array

Affymetrix, Inc. today announced that it will develop and commercialize the Axiom Chinese myDesign Genotyping Array, the first product that provides maximum power for genome-wide association studies specifically on Chinese populations.

28 Jul 2010

Insurers test at-home technology, monitoring devices to help cut heart failure hospitalizations

Technology that aims to keep congestive heart failure patients out of the hospital is gaining traction. The idea is for heart patients to take readings like their weight, blood pressure and other key metrics using wireless and other technologies; the data are then transmitted to a case manager or medical care giver.

28 Jul 2010

U.S. Marshals seize FastSize Extender devices and FastSize EQM Erectile Quality Monitor devices

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $346,954.43 worth of FastSize Extender devices and FastSize EQM™ Erectile Quality Monitor devices, as well as component parts used in the manufacture of the FastSize Extender. The FastSize Extender and the FastSize EQM™ Erectile Quality Monitor are manufactured and distributed by FastSize, LLC of Aliso Viejo, Calif.

28 Jul 2010

FDA clears IL's new point-of-care total bilirubin assay

Instrumentation Laboratory (IL) today announced that it has received clearance from the US Food and Drug Administration (FDA) to market the first-ever, rapid point-of-care, lab-quality blood test for measuring total bilirubin (tBili) in newborns.

28 Jul 2010

AB SCIEX collaborates with CDC to improve laboratory hormone testing technique

AB SCIEX, a global leader in life science analytical technologies, today announced a collaboration with the Centers for Disease Control and Prevention (CDC) and the CDC Foundation to facilitate the use of mass spectrometry technologies in clinical laboratories for hormone testing. This collaboration is intended to help support the CDC's Hormone Standardization Project for improving the reliability of laboratory results used to help assess disease risk and monitor treatment.

28 Jul 2010

Aperio receives patent for image viewing technology

Aperio Technologies, Inc., (Aperio), a global leader in digital pathology for the healthcare and life sciences industry, announced today that the United States Patent and Trademark Office has issued the company patent No. 7,738,688 entitled, "System and Method for Viewing Virtual Slides."

28 Jul 2010

ITelagen to host, support and manage EHR for Allergy and Asthma Associates

ITelagen, a leading provider of electronic health record (EHR) hosting and management announced that it was selected by Allergy and Asthma Associates of Northern California, San Jose, CA to host, support and manage EHR for their medical practice. The solution includes hosting of patient data in ITelagen's SAS-70 Type II certified datacenter and unlimited IT support for staff members.

28 Jul 2010

AirStrip Remote Patient Monitoring solution receives FDA marketing clearance

AirStrip Technologies, a pioneer in mobile medical software applications, today announced that it has received U.S. Food and Drug Administration (FDA) clearance to market the AirStrip Remote Patient Monitoring solution (RPM), including AirStrip RPM CRITICAL CARE and AirStrip RPM CARDIOLOGY.

28 Jul 2010

BioImagene collaborates with ten new academic medical centers to develop digital pathology solutions

BioImagene, Inc., the leading provider of innovative digital pathology solutions has added ten new academic medical centers to its roster of collaborators during the last quarter. Many of these collaborators have been named "America's Best Hospitals 2010-2011: The Honor Roll" by U.S. News and World Report.

28 Jul 2010

NIH awards Akonni $435K to develop point-of-care diagnostics for multi-drug resistant strains of MTB

Akonni Biosystems a molecular diagnostics company focused on developing and manufacturing rapid, high multiplex solutions for infectious disease testing, today announced receipt of a $435K grant from the National Institutes of Biomedical Imaging and Bioengineering at the National Institutes of Health. The award will enable Akonni to accelerate development of its hands-free, sample-to-answer system for identifying a broader range of multi-drug resistant strains of Mycobacterium tuberculosis.

28 Jul 2010

Cytori Therapeutics receives European approval for Celution System

Cytori Therapeutics received expanded European approval (CE Mark) for its Celution System, a medical device that extracts and separates stem and regenerative cells from a patient's own fat tissue. The new indications include key medical applications such as breast reconstruction, repair of soft tissue defects, as well as the facilitation of healing certain types of wounds, such as those resulting from Crohn's disease. This broadens Cytori's ability to offer the Celution System to patients and hospitals and further supports the company's efforts to gain treatment reimbursement.

28 Jul 2010

GE Healthcare completes new $15 million medical technology manufacturing facility in Cardiff, Wales

Life sciences giant GE Healthcare has opened a $15 million medical technology manufacturing facility in Cardiff, Wales. The new facility is based at the 30-acre Maynard Centre, where the company already employs over 400 people.

28 Jul 2010

Industry still making sense of federal e-health regs

Health care industry players are still sorting out the latest regulations on an up-to-$36 billion federal program to encourage doctors and hospitals to use electronic medical records.

28 Jul 2010

FDA approves addition of 10 sites to WorldHeart's Levacor VAD BTT clinical study

World Heart Corporation, a developer of mechanical circulatory systems, announced today that the United States Food and Drug Administration (FDA) has approved the addition of ten sites to the Levacor ventricular assist device (VAD) Bridge-to-Transplant (BTT) clinical study. WorldHeart's pivotal BTT study is now approved to enroll patients at 20 sites in the U.S.

28 Jul 2010

MabCure's MAbs 94% accurate in identifying ovarian cancer

Biotechnology company MabCure, Inc. today announced that a confirmatory study demonstrated the company's proprietary monoclonal antibodies (MAbs) successfully identified ovarian cancer in blood (94 percent accuracy) and with no false positives or cross-reactions with benign ovarian tumors or healthy blood. MabCure's serum diagnostic test is the first to recognize unique tumor markers or cancer fingerprints present only in ovarian cancer, the deadliest of all gynecological cancers.

28 Jul 2010

Growth in dental implant sales to propel bone-graft-substitute market

According to new dental reports by iData Research, the leading global authority in medical device, dental and pharmaceutical market research, the U.S. market for dental implants is expected to regain double-digit growth by 2013, and will help drive the dental prosthetic market to reach over 82 million prosthetic placements by 2016.

27 Jul 2010

Millennium Laboratories urges for increase in physician reimbursement for POC urine drug screening

Millennium Laboratories, Inc., a national, research-based medication monitoring company specifically focused on clinicians who treat chronic pain, strongly advocated for an increase in physician reimbursement for point-of-care urine drug screening at the Annual Clinical Laboratory Public Meeting of the Centers for Medicare and Medicaid Services on July 22, 2010.

27 Jul 2010

ProTron Technologies creates Stethotron Intra-vascular Atherosclerotic Detector

Cardiovascular and cerebrovascular disease are the major causes of death in the world. Atherosclerotic plaque, the narrowing of blood vessels, causes audible turbulence in the bloodstream. Standard and electronic stethoscopes are designed to listen to heart and lung signals between 10-300 Hz. But as these waves do not travel in straight paths, and this frequency is a physiological sound, this uncertainty of origin may cause diagnosis errors.

27 Jul 2010

YesDTC, BioElectronics receive Japanese regulatory review notification for ActiPatch and Allay products

YesDTC Holdings, Inc., a direct-to-consumer marketer and global distributor of consumer goods and products and BioElectronics Corp., manufacturers of innovative pain relieving medical devices, today announced the companies have received notification of the pending review by Japanese government medical device regulators for the ActiPatch™ and Allay™ Menstrual Relief products. This review will take place on Wednesday, July 28th.

27 Jul 2010

Sysmex America to debut expanded cell image analysis portfolio at AACC Annual Conference

Sysmex America, Inc., a leading medical diagnostic instrument manufacturer and information systems developer, today announced plans to debut its expanded cell image analysis portfolio during this year's American Association of Clinical Chemistry's (AACC) Annual Conference and Clinical Lab Expo July 25 - 29 in Anaheim, California.

From Sysmex America, Inc. 27 Jul 2010

Device / Technology News

Affymetrix to develop, commercialize Axiom Chinese myDesign Genotyping Array

Insurers test at-home technology, monitoring devices to help cut heart failure hospitalizations

U.S. Marshals seize FastSize Extender devices and FastSize EQM Erectile Quality Monitor devices

FDA clears IL's new point-of-care total bilirubin assay

AB SCIEX collaborates with CDC to improve laboratory hormone testing technique

Aperio receives patent for image viewing technology

ITelagen to host, support and manage EHR for Allergy and Asthma Associates

AirStrip Remote Patient Monitoring solution receives FDA marketing clearance

BioImagene collaborates with ten new academic medical centers to develop digital pathology solutions

NIH awards Akonni $435K to develop point-of-care diagnostics for multi-drug resistant strains of MTB

Cytori Therapeutics receives European approval for Celution System

GE Healthcare completes new $15 million medical technology manufacturing facility in Cardiff, Wales

Industry still making sense of federal e-health regs

FDA approves addition of 10 sites to WorldHeart's Levacor VAD BTT clinical study

MabCure's MAbs 94% accurate in identifying ovarian cancer

Growth in dental implant sales to propel bone-graft-substitute market

Millennium Laboratories urges for increase in physician reimbursement for POC urine drug screening

ProTron Technologies creates Stethotron Intra-vascular Atherosclerotic Detector

YesDTC, BioElectronics receive Japanese regulatory review notification for ActiPatch and Allay products

Sysmex America to debut expanded cell image analysis portfolio at AACC Annual Conference

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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