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Japan's MHLW approves InSightec's ExAblate MRgFUS system

InSightec Ltd. announced today that Japan's Ministry of Health, Labor and Welfare (MHLW) has approved the company's ExAblate(R) MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with uterine fibroids.

18 Jan 2010

ChromoCure publishes results of cervical cancer study using its Chromosomal Scanner Technology

ChromoCure, Inc. is pleased to announce the publication of the Cervical Cancer Study, PRE-CLINICAL SYSTEM TESTING AND PERFORMANCE ASSESSMENT, conducted in conjunction with a major international Cancer Clinic. The study analyzed samples supplied by the Cancer Clinic with its Proprietary Chromosomal Scanner Technology (full text can be found @ www.ChromoCure.com/library). The study demonstrated not only the correctness of the company's cancer detection approach but also the accuracy of the scan itself. The scanner performed perfectly with flawless detection results.

18 Jan 2010

JDRF and Animas partner to develop an automated system for better control of type 1 diabetes

The Juvenile Diabetes Research Foundation today announced an innovative partnership with Animas Corporation to develop an automated system to help people with type 1 diabetes better control their disease -- the first step on the path to what would be among the most revolutionary advancements in treating type 1 diabetes: the development of an artificial pancreas, a fully automated system to dispense insulin to patients based on real-time changes in blood sugar levels.

18 Jan 2010

New mobile dental radiology service from 3D Mobile Imaging of the CSRA

(3D Mobile Imaging of the CSRA and AFP Imaging Corporation Dental practitioners in Georgia and South Carolina can now offer the latest technology and greatest convenience to their patients thanks to a new mobile dental radiology service.

18 Jan 2010

FDA admits concern, but does not ban BPA: Consumers Union disappointed

Consumers Union, the nonprofit publisher of Consumer Reports, expressed disappointment with the U.S. Food & Drug Administration's (FDA) failure to ban the chemical bisphenol A (BPA), despite announcing today that there is cause for concern over its potential effect on children. Consumers Union believes that that there is enough scientific evidence to date to warrant a ban on BPA in food contact products now.

18 Jan 2010

Covidien files patent infringement lawsuit against Ethicon Endo-Surgery

Covidien, a leading global provider of healthcare products, today announced that, through its family of companies, a lawsuit was filed in the United States District Court for the District of Connecticut against Ethicon Endo-Surgery, Inc., a Johnson & Johnson company, relating to Ethicon’s Harmonic® line of ultrasonic surgical products.

18 Jan 2010

Cerus' INTERCEPT platelets therapeutically effective even after seven days of storage

Cerus Corporation announced today that INTERCEPT-treated platelet components were found to be effective for patient support following extended six and seven day storage in a clinical study conducted at four sites in Europe. These data further confirm the safety and therapeutic efficacy of platelets treated with the INTERCEPT Blood System, a pathogen inactivation treatment designed to protect against transfusion-transmitted diseases.

18 Jan 2010

MediSens Wireless to begin its wireless body-monitoring system clinical trials following FDA approval

MediSens Wireless, a startup company in UCLA's on-campus technology incubator at the California NanoSystems Institute, has obtained approval under federal Food and Drug Administration guidelines to begin clinical trials on its novel wireless body-monitoring system, which assesses muscle and neuromotor functions in the upper extremities.

18 Jan 2010

Results show neoadjuvant chemoradiotherapy improves patients with EC

Esophageal carcinoma (EC) is one of the major malignant diseases worldwide. Surgery alone cannot obtain satisfactory effects in patients with EC. Neoadjuvant chemoradiotherapy has been a hotspot for EC treatment research. Several related randomized controlled trials (RCTs) have been published, but opinions vary among clinicians as to the therapeutic effect of the new method.

18 Jan 2010

Treatment for chronic hepatitis C with pegylated-interferon and ribavirin proves effective

The current standard treatment for chronic hepatitis C with pegylated-interferon (PEG-IFN) and ribavirin is effective in approximately 50%-60% of patients, so that a substantial proportion of patients remain unresponsive.

18 Jan 2010

Protectus Medical Devices and Moll Industries sign manufacturing agreement

Protectus Medical Devices, Inc. ("Protectus Medical Devices"), a developer and marketer of innovative medical devices, today announced the signing of a three-year manufacturing agreement with Moll Industries, Inc. to provide injection molded plastic manufacturing services for the Protectus Safety Syringe.

17 Jan 2010

NewCardio awarded core patent concerning its CardioBip ECG telemonitoring solution

NewCardio, Inc., a cardiac diagnostic technology provider, announced today that on January 12, 2010, it received notice of allowance for U.S. patent 7,647,093, titled "Apparatus and method for cordless recording and telecommunication transmission of three special ECG leads and their processing," from the U.S. Patent and Trademark Office.

17 Jan 2010

CSI receives authorization to begin its pivotal trial of ORBIT II

Cardiovascular Systems, Inc. (CSI), has received Food and Drug Administration (FDA) conditional Investigational Device Exemption (IDE) approval to evaluate the safety and effectiveness of its Diamondback 360® System in the treatment of calcified coronary lesions. With this conditional approval, CSI is authorized to begin its pivotal trial, ORBIT II, in early 2010 and initially enroll up to 100 patients at as many as 50 U.S. sites.

17 Jan 2010

California health information organization closes after losing state bid

A California nonprofit meant to facilitate health information exchange has closed its doors after losing a bid to become the state's main exchange organization, Modern Healthcare reports. Board members for California Regional Health Information Organization, or CalRHIO, voted to disband after their company failed to win contracts with the state or negotiate a partnership that would fulfill state requirements.

17 Jan 2010

Boston Scientific commences patient enrollment in its WallFlex Biliary RX Fully Covered Stent trial

Boston Scientific Corporation today announced that the first patient has been enrolled in a clinical trial to evaluate its WallFlex® Biliary RX Fully Covered Stent for the treatment of benign bile duct strictures. This multi-center, prospective study plans to enroll 187 patients at 11 centers worldwide over the next 18 months.

17 Jan 2010

CT-guided biopsy: An alternative method for patients with pancreatic masses

It is reasonable to obtain a histological diagnosis before treating patients who have pancreatic masses and are unsuitable or unwilling to undergo surgery. As the pancreas is a deep seated organ surrounded by other vital structures, it is a challenge for the physician to obtain an adequate specimen for histological examination.

17 Jan 2010

European approval for Abbott's new ovarian cancer diagnostic test

A new diagnostic tool, which studies show can aid in determining the risk of whether a pelvic mass is benign or malignant, is now available in Europe. This simple blood test is expected to help in the assessment of epithelial ovarian cancer, the most lethal form of gynecological cancer.

14 Jan 2010

Seattle Biomedical Research Institute implements UltiPro to enhance IT operations

Ultimate Software, a leading provider of end-to-end strategic human resources, payroll, and talent management solutions, announced today that Seattle Biomedical Research Institute (SBRI), the largest independent, nonprofit organization in the U.S. focused solely on infectious disease research, is experiencing IT improvements since switching from an on-premise human resource management system (HRMS) to UltiPro delivered through Software-as-a-Service (SaaS).

13 Jan 2010

Cardiac Science and MEDENT announce new partnership deal

Cardiac Science Corporation, a global leader in automated external defibrillator (AED) and diagnostic cardiac monitoring devices that connect to electronic medical record (EMR) and hospital information systems, today announced a partnership with MEDENT, a leading provider of practice automation and EMR/EHR systems.

13 Jan 2010

Multimmune GmbH and Boulder Diagnostics partner to develop HSP70 lateral flow point of care test

Multimmune GmbH and Boulder Diagnostics Inc. announce today the joint development of an HSP70 lateral flow point of care test. Multimmune has discovered that many tumor types display the heat shock protein 70 (Hsp70) on the cell surface.

13 Jan 2010

Device / Technology News

Japan's MHLW approves InSightec's ExAblate MRgFUS system

ChromoCure publishes results of cervical cancer study using its Chromosomal Scanner Technology

JDRF and Animas partner to develop an automated system for better control of type 1 diabetes

New mobile dental radiology service from 3D Mobile Imaging of the CSRA

FDA admits concern, but does not ban BPA: Consumers Union disappointed

Covidien files patent infringement lawsuit against Ethicon Endo-Surgery

Cerus' INTERCEPT platelets therapeutically effective even after seven days of storage

MediSens Wireless to begin its wireless body-monitoring system clinical trials following FDA approval

Results show neoadjuvant chemoradiotherapy improves patients with EC

Treatment for chronic hepatitis C with pegylated-interferon and ribavirin proves effective

Protectus Medical Devices and Moll Industries sign manufacturing agreement

NewCardio awarded core patent concerning its CardioBip ECG telemonitoring solution

CSI receives authorization to begin its pivotal trial of ORBIT II

California health information organization closes after losing state bid

Boston Scientific commences patient enrollment in its WallFlex Biliary RX Fully Covered Stent trial

CT-guided biopsy: An alternative method for patients with pancreatic masses

European approval for Abbott's new ovarian cancer diagnostic test

Seattle Biomedical Research Institute implements UltiPro to enhance IT operations

Cardiac Science and MEDENT announce new partnership deal

Multimmune GmbH and Boulder Diagnostics partner to develop HSP70 lateral flow point of care test

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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