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St. Jude Medical to commence enrollment in IRASE AF trial

St. Jude Medical, Inc. today announced it has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin enrollment in the IRASE AF (IRrigated Ablation System Evaluation for AF) trial, a multicenter, randomized, single-blind study evaluating the safety and efficacy of the company’s Duo 12 port open irrigated catheter ablation system for treatment of Atrial Fibrillation (AF). AF is the most common cardiac arrhythmia (abnormal heartbeat), affecting an estimated 3.3 million Americans and millions more worldwide.

4 Feb 2010

TGen, Geisinger Health System sign strategic research agreement

The Translational Genomics Research Institute (TGen) and Geisinger Health System today announced the signing of a strategic research agreement that provides for a focused look at the gaps in clinical medicine where biomedical research can make a difference.

4 Feb 2010

MedeFile International and NHN sign marketing and distribution agreement

MedeFile International, Inc., a leader in portable electronic medical records management, announced today that it has signed a marketing and distribution agreement with the National Homecare Network (NHN).

4 Feb 2010

HealthSport's bi-layer edible film strip technology related patent application receives Mexican approval

HealthSport, Inc., the preeminent formulator and developer of edible, multi-layer film strips that deliver drug and dietary supplement actives through buccal and sublingual absorption as well as oral ingestion, announced today that the Mexican Institute of Industrial Property has approved HealthSport's patent application relating to its bi-layer edible film strip technology.

4 Feb 2010

Tough economy adds stress to hospitals; Community health centers help fill gaps

Hospitals get mixed marks while many suffer from the effects of the struggling economy. Meanwhile, community health centers increasingly provide more care and help fill in health care gaps.

4 Feb 2010

Court weighs patents for human genes

The American Civil Liberties Union has sued a genetics company that holds patents on breast- and ovarian-cancer-causing genes, saying their claims on the two genes hinders further research by other companies and scientists, the Associated Press/CBS News reports.

4 Feb 2010

UBC announces the opening of new global office in Tokyo, Japan

nited BioSource Corporation (UBC) today announced the opening of its newest global office in Tokyo, Japan. The UBC office will be led by Kumpei Kobayashi, PharmD, a biopharmaceutical industry veteran with over 20 years of product development experience throughout the Asia-Pacific region.

4 Feb 2010

AuthenTec files patent infringement suit against UPEK

AuthenTec (NASDAQ: AUTH), the world’s leading provider of smart fingerprint sensors and solutions, announced that it has filed legal claims today against UPEK, Inc. for the infringement of five AuthenTec patents and trade secret misappropriation in the U.S. District Court for the Northern District of California.

4 Feb 2010

Phase 2a clinical trial results of VX-809 in patients with CF announced

Vertex Pharmaceuticals Incorporated today announced results from a preliminary analysis of data from a 28-day Phase 2a clinical trial of VX-809 in patients with cystic fibrosis (CF) who are homozygous for the F508del mutation.

4 Feb 2010

First Choice Emergency Room donates to Haiti victims

First Choice Emergency Room's owner, along with the company's management, medical staff, and employees, are making multiple monetary and in-kind donations to the victims of the January 12 earthquake in Haiti.

4 Feb 2010

Inverness Medical Innovations to acquire Kroll's Substance Abuse Testing division

Inverness Medical Innovations, Inc., a global leader in enabling individuals to take charge of their health at home through the merger of rapid diagnostics and health management, announced today that it has entered into a binding agreement with Kroll Inc., a subsidiary of Marsh and McLennan Companies, Inc. to purchase its Substance Abuse Testing division (Kroll Laboratory Specialists, Inc.), its business unit providing forensic quality substance abuse testing products and services across the United States.

4 Feb 2010

Validation results of SmartChip Real-Time PCR System to be presented at CHI's conference

WaferGen Biosystems, Inc., a leading developer of state-of-the-art genetic analysis systems, today announced that WaferGen scientists will present validation results of the company's SmartChip™ Real-Time PCR System at Cambridge Healthcare Institute's 17th International Molecular Medicine Tri-Conference.

3 Feb 2010

Researchers discover anomalies that cause lack of motivation in ADHD children

Until now, attention-deficit/hyperactivity disorder (ADHD) was related to alterations in the brain affecting attention and cognitive processes. Researchers at Universitat Aut-noma de Barcelona and the Vall d'Hebron University Hospital for the first time have discovered anomalies in the brain's reward system related to the neural circuits of motivation and gratification.

3 Feb 2010

Poll: Health care 'damage' to Democrats 'has been done'

Politico: "Democrats will face nearly the same political environment this fall whether or not they pass health care reform legislation, according to a new poll out Tuesday." The poll, by Public Policy Polling, found that "Republicans currently have a generic ballot advantage of 43 percent to 40 percent in races for Congress. ... 'At this point, it looks like the political damage for Democrats on health care has been done,' PPP President Dean Debnam said. "The poll, conducted Jan. 29 - 31, has a margin of error of plus or minus 4.1 percentage points" (Barr, 2/2).

3 Feb 2010

States consider their own health reform ideas

"Supporters of a bill that seeks to bar lifetime and annual payment caps on health insurance plans in Maine say they expect a large crowd at a legislative committee's hearing on the proposal." The same topic has been considered by the U.S. Congress as part of Democrats health overhaul (2/3).

3 Feb 2010

IBM announces definitive agreement to acquire Initiate Systems

IBM today announced it has signed a definitive agreement to acquire Initiate Systems, a market leader in data integrity software for information sharing among healthcare and government organizations. Initiate's software helps healthcare clients work more intelligently and efficiently with timely access to patient and clinical data. It also enables governments to share information across multiple agencies to better serve citizens.

3 Feb 2010

MedCath announces unaudited operating results for first-quarter of fiscal 2010

MedCath Corporation, a healthcare provider focused on high acuity healthcare services, predominately the diagnosis and treatment of cardiovascular disease, today announced its unaudited operating results for its first quarter of fiscal 2010, which ended December 31, 2009.

3 Feb 2010

Major study of perfusion imaging under way to assess value of alternative diagnostic methods

Cardiologists and heart imaging specialists at 15 medical centers in eight countries, and led by researchers at Johns Hopkins, have enrolled the first dozen patients in a year-long investigation to learn whether the subtle squeezing of blood flow through the inner layers of the heart is better than traditional SPECT nuclear imaging tests and other diagnostic radiology procedures for accurately tracking the earliest signs of coronary artery clogs.

3 Feb 2010

Questionable health insurance plans cause concern

Officials worry that people with no insurance will be drawn in by questionable health insurance plans. ABC News reports: The "[h]ealth care overhaul is stalled, resulting in a proliferation of plans that don't fully protect people, officials said. Watchdogs worry about two kinds of plans in particular."

3 Feb 2010

Keryx Biopharmaceuticals reaches agreement with FDA on SPA for Phase 3 trial of KRX-0401

Keryx Biopharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in patients with refractory metastatic colorectal cancer.

3 Feb 2010