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Diagnostic Hybrids receives Chinese SFDA approval for D3 Ultra DFA Respiratory Virus Screening and ID Kit

Diagnostic Hybrids, a Quidel Company, received approval from the People's Republic of China's State Food and Drug Administration (SFDA) for its D3 Ultra DFA Respiratory Virus Screening and ID Kit. The D3 Ultra DFA Respiratory Virus Screening and ID Kit is a direct fluorescence assay (DFA) that provides rapid, sensitive and specific screening and identification of Influenza A, Influenza B, Parainfluenza 1, 2, & 3, Respiratory Syncytial Virus and Adenovirus.

1 Jul 2010

FIOCRUZ receives Brazil's Anvisa regulatory approval to market Chembio's Dual Path Platform HIV 1/2 rapid test

Chembio Diagnostics, Inc., which develops, manufactures, markets and licenses point-of-care diagnostic tests, has been notified that Bio-Manguinhos, a division of the Oswaldo Cruz Foundation of Brazil ("FIOCRUZ"), has received regulatory approval from Brazil's National Health Surveillance Agency (Anvisa) to market Chembio's Dual Path Platform (DPP®) HIV 1/2 rapid test for use with oral fluid, blood, serum or plasma samples. The approval triggers $400,000 in license revenues payable to Chembio within 120 days of the date of approval.

1 Jul 2010

Düsseldorf court awards AGA Medical €2.1 million in Occlutech patent infringement case

AGA Medical Holdings, Inc. today announced the Düsseldorf Regional Court has awarded €2.1 million in damages to AGA Medical as a result of a patent infringement case filed by AGA Medical against Occlutech GmbH (Occlutech), based in Jena, Germany. AGA Medical is a leading developer of interventional devices for the minimally invasive treatment of structural heart defects and vascular abnormalities.

1 Jul 2010

IRIS submits 510(k) application for clearance of iChemVELOCITY and iRICELL Urinalysis Workstation

IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, announced today that its IRIS Diagnostics Division submitted on June 30, 2010, a 510(k) pre-market notification application to the U.S. Food and Drug Administration (FDA) requesting regulatory clearance for its iChem®Velocity™ Automated Urine Chemistry Analyzer and iRICELL® Urinalysis Workstation.

1 Jul 2010

Uroplasty broadens neuromodulation patent portfolio

Uroplasty, Inc., a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunctions, announced today the issuance of United States Patent No. 7,729,772 which covers a method for using an implantable neuromodulation system in the treatment of urinary incontinence by neuromodulation or stimulation of the tibial nerve. The neuromodulation system includes a portable, external transmitter and a receiver implanted subcutaneously in the leg or ankle near the tibial nerve.

1 Jul 2010

AMP comments on array-based cytogenetic tests at FDA's public meeting

Today, the Association for Molecular Pathology presented comments at the US Food & Drug Administration's public meeting on array-based cytogenetic tests. The FDA convened the meeting to seek answers to more than a dozen questions they had on how to evaluate the performance, interpret results and report findings of array-based cytogenetic tests for copy number variation.

1 Jul 2010

Lensless cell phone microscope

Cell phones are accumulating a Swiss Army Knife-esqe assortment of capabilities; substituting as cameras, providing internet access, and soon operating as medical labs if Aydogan Ozcan's plans come to fruition. This month's cover article of the journal Lab on a Chip features the latest creation by the Ozcan group, a functioning prototype of a cell phone microscope.

1 Jul 2010

HHS Secretary to introduce www.HealthCare.gov consumer empowerment tool

HHS Secretary Kathleen Sebelius will introduce www.HealthCare.gov, a powerful new tool for consumers. The Secretary and Todd Park, Chief Technology Officer for HHS, will roll out the new site, called for in the Affordable Care Act, demonstrate some of its important features and answer questions from the media.

1 Jul 2010

Experts examine corporate websites dedicated to 100 best-selling prescription drugs

Dartmouth Linguistics Professor Lewis Glinert and Jon Schommer, the associate head of the Department of Pharmaceutical Care and Health Systems at the University of Minnesota, have examined the corporate websites dedicated to the 100 best-selling prescription drugs. They found a startling lack of consistency in an industry where advertising standards are regulated by the Food and Drug Administration.

1 Jul 2010

Nanostructured assemblies for dental application

Scientists are reporting an advance toward the next big treatment revolution in dentistry - the era in which root canal therapy brings diseased teeth back to life, rather than leaving a "non-vital" or dead tooth in the mouth. In a report in the monthly journal ACS Nano, they describe a first-of-its-kind, nano-sized dental film that shows early promise for achieving this long-sought goal.

1 Jul 2010

Follicle aspiration needle Swemed Sense gives less pain, bleeding compared with conventional needle

“The follicle aspiration needle Swemed Sense™ makes it possible to work in a new way, which is more favourable for patients, and at the same time it meets all the other quality requirements for a follicle aspiration needle”

1 Jul 2010

Greenway receives U.S. Patent for clinical template builder module

Greenway Medical Technologies, Inc., provider of the integrated, single-database electronic health record (EHR), practice management and interoperability solution PrimeSuite®, has been awarded a patent for its innovative template builder module used to create custom clinical templates that can be integrated with financial and administrative workflows.

1 Jul 2010

New research identifies memory and brain scan as best tests for predicting Alzheimer's disease

New research has identified the memory and brain scan tests that appear to predict best whether a person with cognitive problems might develop Alzheimer's disease. The research is published in the June 30, 2010, online issue of Neurology, the medical journal of the American Academy of Neurology.

1 Jul 2010

Gore receives European CE Mark approval for 25 cm GORE VIABAHN Endoprosthesis

W. L. Gore & Associates today announced that it has received European CE Mark approval for the 25 cm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface. The new 25 cm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface is the longest length stent-graft available, designed to cover more of the lesion in the Superficial Femoral Artery potentially reducing the need for multiple devices.

1 Jul 2010

Varian, Brainlab expand partnership to incorporate Novalis technology with TrueBeam STx system

Varian Medical Systems and Brainlab today announced the expansion of their partnership to incorporate Novalis technology and other Novalis Radiosurgery Program elements with the recently launched TrueBeam STx system. The expanded suite of products will be badged "Novalis powered by TrueBeam STx."

1 Jul 2010

BioImagene, KUMC partner to develop Companion Algorithms for digital pathology

BioImagene, Inc., the leading provider of innovative digital pathology solutions, announced a collaboration with the University of Kansas Medical Center (KUMC) Department of Pathology & Laboratory Medicine to develop Companion Algorithms™ for next generation companion diagnostics for digital pathology.

1 Jul 2010

Rubicon Genomics' PicoPlex linear WGA technology proves effective in clinical study

Rubicon Genomics today announced that its PicoPlex linear whole genome amplification technology was proven to be effective in an independent clinical study organized by the European Society for Human Reproduction and Embryology. At a press conference during its 26th Annual Meeting in Rome, ESHRE reported the success of its "groundbreaking proof of principle study" showing that a new approach incorporating PicoPlex could more accurately detect and characterize chromosomal abnormalities in human eggs.

1 Jul 2010

Simbionix, USF Health receive BIRD Grant for development of Laparoscopic Hysterectomy simulation module

Simbionix Ltd., a subsidiary of Simbionix USA Corporation, the world's leading provider of medical education and simulation training products for medical professionals and the healthcare industry, and USF Health, an organization dedicated to creating a model of health care based on understanding the full spectrum of health, are proud to announce that together they received a BIRD (Binational Industrial Research and Development) Grant to support the development of a Laparoscopic Hysterectomy simulation module.

1 Jul 2010

CDC issues new guidelines on detection of Mycobacterium tuberculosis infections

Today the United States Centers for Disease Control and Prevention issued new and important guidelines on the detection of Mycobacterium tuberculosis infections, the causative agent of tuberculosis. In these landmark guidelines, CDC advises that Interferon Gamma Release Assay blood tests are now preferred over the 100+-year-old tuberculin skin test for diagnosing TB infection in certain populations, including people who typically do not return for the necessary reading of TST results, and those who have received Bacille Calmette-Guerin as a vaccine or for cancer therapy

1 Jul 2010

Pre-clinical data of BiTE antibody technology published in PNAS

Micromet, Inc., today announced the publication of pre-clinical data in the Proceedings of the National Academy of Sciences, demonstrating the potency of new product candidates based on the Company's proprietary BiTE antibody technology. BiTE antibodies are a new class of agents designed to harness a patient's T cells to kill cancer cells.

1 Jul 2010

Device / Technology News

Diagnostic Hybrids receives Chinese SFDA approval for D3 Ultra DFA Respiratory Virus Screening and ID Kit

FIOCRUZ receives Brazil's Anvisa regulatory approval to market Chembio's Dual Path Platform HIV 1/2 rapid test

Düsseldorf court awards AGA Medical €2.1 million in Occlutech patent infringement case

IRIS submits 510(k) application for clearance of iChemVELOCITY and iRICELL Urinalysis Workstation

Uroplasty broadens neuromodulation patent portfolio

AMP comments on array-based cytogenetic tests at FDA's public meeting

Lensless cell phone microscope

HHS Secretary to introduce www.HealthCare.gov consumer empowerment tool

Experts examine corporate websites dedicated to 100 best-selling prescription drugs

Nanostructured assemblies for dental application

Follicle aspiration needle Swemed Sense gives less pain, bleeding compared with conventional needle

Greenway receives U.S. Patent for clinical template builder module

New research identifies memory and brain scan as best tests for predicting Alzheimer's disease

Gore receives European CE Mark approval for 25 cm GORE VIABAHN Endoprosthesis

Varian, Brainlab expand partnership to incorporate Novalis technology with TrueBeam STx system

BioImagene, KUMC partner to develop Companion Algorithms for digital pathology

Rubicon Genomics' PicoPlex linear WGA technology proves effective in clinical study

Simbionix, USF Health receive BIRD Grant for development of Laparoscopic Hysterectomy simulation module

CDC issues new guidelines on detection of Mycobacterium tuberculosis infections

Pre-clinical data of BiTE antibody technology published in PNAS

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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