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FDA provides guidance to help caregivers, patients safely use complex medical devices in home

The U.S. Food and Drug Administration today announced a new initiative to ensure that caregivers and patients safely use complex medical devices in the home.

21 Apr 2010

Cochlear implantation improves comprehension and spoken language expression in children under 5

Children under 5 years of age with severe hearing loss who underwent cochlear implantation experienced greater improvement in comprehension and expression in spoken language than would be predicted from their pre-implantation language scores, with younger age at implantation associated with greater improvements, according to a study in the April 21 issue of JAMA.

21 Apr 2010

Genetic dermatology tests merge with DermaGenoma

Pioneering genetic tests in key areas of dermatology today merged into one molecular dermatology research and development innovator called DermaGenoma, Inc.

21 Apr 2010

Defects in carbon nanotubes stimulate body's natural immune response: Study

Yale University engineers have found that the defects in carbon nanotubes cause T cell antigens to cluster in the blood and stimulate the body's natural immune response.

21 Apr 2010

Capario secures CAQH CORE Phase II Certification for Phoenix Processing System

Capario, a leading provider of revenue cycle management solutions that connect healthcare payers and providers nationwide, today announced it has achieved the CAQH® Committee on Operating Rules for Information Exchange (CORE®) Phase II Certification for its Phoenix Processing System.

21 Apr 2010

E-prescribing to grow as DEA eases regulation

The Wall Street Journal: "Doctors are increasingly prescribing medications electronically, abandoning the traditional paper scripts that can result in drug errors due to hard-to-read writing or coverage denials by a patient's insurer." E-prescribing tripled last year to 191 million according to the online prescribing leader Surescripts.

21 Apr 2010

FDA eyes home-based medical equipment for regulation

"With hospitals discharging patients after ever-shorter stays, more people are recovering and continuing post-operative care, or treating chronic conditions, with sophisticated medical equipment at home," The Wall Street Journal reports.

21 Apr 2010

ForteBio introduces new Octet QK(e) instrumentation system

ForteBio®, Inc., a leading supplier of label-free technology that accelerates the development of biotherapeutic and pharmaceutical products, today announced the launch of its new Octet QK(e) instrumentation system. The new system, the next generation of the company's initial eight-channel Octet QK instrument, provides significantly increased sensitivity, enabling analysis of small proteins and peptides. Additionally, the Octet QK(e) system enables biosensors to be re-racked, for increased workflow flexibility and cost savings.

20 Apr 2010

Haihong suspends government bidding for Biosite's Triage products in China

On April 1, 2010, Haihong Medical Device Bidding Co., the largest government purchase bidding company for medical devices in China, suspended all government bidding for Biosite's Triage products pending the resolution of the lawsuit between Chinmax Medical Systems, Inc. and Inverness Medical Beijing Co. Ltd. (IMB), a subsidiary of Inverness Medical Innovations, Inc. ( IMA).

20 Apr 2010

Air Methods delivers first medically equipped Bell 429 helicopter to Mercy One

Air Methods Corporation, the largest air medical transportation company in the world, recently delivered the first medically equipped Bell 429 helicopter to Mercy One, its hospital-based services customer in Des Moines, Iowa. Air Methods' Products Division is the first in the world to design, engineer, manufacture, and certify a medical interior for the Bell 429 helicopter.

20 Apr 2010

Endosense releases TactiCath force-sensing ablation catheter

Endosense, a medical technology company focused on improving the efficacy, safety and reproducibility of catheter ablation for the treatment of cardiac arrhythmias, has announced the commercial release of its next generation TactiCath force-sensing ablation catheter. Recently granted CE mark and unveiled this month at the DGK 2010 - German Cardiac Society meeting in Mannheim, Germany, the second generation product includes an elegantly enhanced catheter along with a feature-rich supporting system called the TactiSys™.

20 Apr 2010

New web-based service for analyzing, visualizing and managing DNA sequencing data

DNAnexus, Inc. today announced the commercial launch of its web-based service for analyzing, visualizing, and managing next-generation DNA sequencing data. Andreas Sundquist, Ph.D., co-founder and CEO, will introduce the solution publicly for the first time today at the annual Bio-IT World Conference and Expo in Boston, Massachusetts.

20 Apr 2010

Genentech to pay Seattle Genetics $9.5M for renewing licenses under existing ADC collaboration agreement

Seattle Genetics, Inc. today announced that Genentech, Inc., a wholly owned member of the Roche Group, will pay $9.5 million to renew exclusive licenses to specific targets and extend the research term under the parties' existing antibody-drug conjugate (ADC) collaboration agreement. Under the terms of the agreement, Genentech has rights to use Seattle Genetics' ADC technology with antibodies against targets selected by Genentech.

20 Apr 2010

Total Pricing Systems of Moncton introduces PPS Assist!

Total Pricing Systems of Moncton, a leading communication services supplier to the pharmaceutical and medical device industry since 1991, has introduced Canada's first industry communication delivery and management approach that will significantly reduce the industries' ecological footprint while also donating money to health charities.

20 Apr 2010

MDx to better health care, cut costs and make personalized medicine a worldwide reality

The rapidly growing field of molecular diagnostics is addressing critical unmet needs in healthcare by enabling early disease detection and better disease segmentation, and by predicting relapse and response to therapy, according to a global industry review released today by Scientia Advisors.

20 Apr 2010

Investment report on Sequenom from MicroStockProfit.com

MicroStockProfit.com announces an investment report featuring Sequenom Inc. The report includes financial, comparative and investment analysis, and industry information you need to know to make an educated investment decision.

20 Apr 2010

Medical device industry leaders to meet with lawmakers, government officials at MDMA annual meeting

As the U.S. Food and Drug Administration is reviewing pivotal regulatory procedures for one of America's fastest growing sectors, industry leaders will gather to meet with lawmakers and government officials at the 16th Annual Meeting of the Medical Device Manufacturers Association on May 24-26, 2010 at the Park Hyatt in Washington, DC.

20 Apr 2010

AngioDynamics commences treatment in NanoKnife IRE System pilot study for HCC

AngioDynamics today announced the first patient treatment and growing enrollment in a pilot study of the use of the Company's NanoKnife® Irreversible Electroporation (IRE) System in the treatment of early stage hepatocellular carcinoma (HCC), or primary liver cancer. This clinical trial is being conducted under the supervision of Professor Jordi Bruix of the Barcelona Clinic Liver Cancer Group of the University of Barcelona and Professor Riccardo Lencioni of the University of Pisa School of Medicine.

20 Apr 2010

STERIS reaches agreement with FDA over liquid chemical sterilization system consent decree

STERIS Corporation today announced it has reached an agreement with the U.S. Food and Drug Administration (FDA) on the terms of a consent decree regarding its SYSTEM 1® liquid chemical sterilization system. Included in the agreement is a Transition Plan with a Rebate Program for current SYSTEM 1 Customers in the U.S. The consent decree is subject to approval by the U.S. District Court for the Northern District of Ohio.

20 Apr 2010

ATS Medical announces first ATS 3f Aortic Bioprosthesis commercial implant in China

ATS Medical, Inc., manufacturer and marketer of state-of-the-art cardiac surgery products and services today announced the first commercial implant of the ATS 3f® Aortic Bioprosthesis was recently completed by Liu Zhi Gang, MD at Fu Wai Hospital in Beijing, China. Fu Wai Hospital is the largest cardiac surgery center in Asia and a full line of ATS products are utilized by their surgeons. ATS received permission from the Chinese State Food and Drug Administration (SFDA) to market the ATS 3f Aortic Bioprosthesis in March.

20 Apr 2010

Device / Technology News

FDA provides guidance to help caregivers, patients safely use complex medical devices in home

Cochlear implantation improves comprehension and spoken language expression in children under 5

Genetic dermatology tests merge with DermaGenoma

Defects in carbon nanotubes stimulate body's natural immune response: Study

Capario secures CAQH CORE Phase II Certification for Phoenix Processing System

E-prescribing to grow as DEA eases regulation

FDA eyes home-based medical equipment for regulation

ForteBio introduces new Octet QK(e) instrumentation system

Haihong suspends government bidding for Biosite's Triage products in China

Air Methods delivers first medically equipped Bell 429 helicopter to Mercy One

Endosense releases TactiCath force-sensing ablation catheter

New web-based service for analyzing, visualizing and managing DNA sequencing data

Genentech to pay Seattle Genetics $9.5M for renewing licenses under existing ADC collaboration agreement

Total Pricing Systems of Moncton introduces PPS Assist!

MDx to better health care, cut costs and make personalized medicine a worldwide reality

Investment report on Sequenom from MicroStockProfit.com

Medical device industry leaders to meet with lawmakers, government officials at MDMA annual meeting

AngioDynamics commences treatment in NanoKnife IRE System pilot study for HCC

STERIS reaches agreement with FDA over liquid chemical sterilization system consent decree

ATS Medical announces first ATS 3f Aortic Bioprosthesis commercial implant in China

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