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Biodesix awarded US patent for VeriStrat serum test

Biodesix, Inc., a company developing and commercializing molecular diagnostics for personalized medicine, announced today that the United States Patent and Trademark Office has awarded to the Company patent number 7,736,905. The patent provides coverage for the Company's first product, VeriStrat®, which is used by physicians to help guide therapy for patients with advanced lung cancer. The allowed claims are directed towards the serum-based identification of patients likely to benefit from epidermal growth factor targeted therapy.

22 Jun 2010

Surveillance colonoscopy is effective when targeted to high-risk patients: Study

Surveillance colonoscopy is effective and cost-effective when targeted to high-risk patients, according to a new study in Gastroenterology, the official journal of the American Gastroenterological Association Institute. However, overuse of surveillance colonoscopy could be excessively costly or even harmful.

22 Jun 2010

Biotage launches ISOLUTE SLE+ sample preparation columns

Biotage, a leading supplier of tools and technology for medicinal and analytical chemistry, announced the introduction of ISOLUTE SLE+ High-Performance Supported Liquid Extraction sample preparation columns. The announcement occurred during the 58th ASMS Conference on Mass Spectrometry and Allied Topics in Salt Lake City, Utah USA.

22 Jun 2010

KYPHON ActivOs 10 Bone Cement with HA launched to treat patients with VCFs

Medtronic, Inc. today announced the launch of KYPHON ActivOs 10 Bone Cement with Hydroxyapatite, a polymethylmethacrylate bone cement containing hydroxyapatite for use in the treatment of patients with vertebral compression fractures who are undergoing minimally invasive surgery with KYPHON Balloon Kyphoplasty.

22 Jun 2010

FDA to hold workshop on medical device innovation to address unmet public health needs

Each day, medical devices from renal dialysis machines to implantable defibrillators help prevent, diagnose, treat, and monitor serious and life-threatening diseases. After taking years to develop, these devices then undergo a regulatory review process before entering the marketplace. It then takes even more time for them to be adopted into clinical practice and for patients to realize the benefits.

22 Jun 2010

Research article sheds light on liability concerns and electronic health records systems

Electronic health record systems likely will soon become a fixture in medical settings. Advocates claim they will reduce health care costs and improve medical outcomes, which could be critical since the new health care reform law increases access for millions of Americans. Although benefits of bringing information technology to health records can be substantial, EHR systems also give rise to increased liability risks for health care providers due to possible software or hardware problems or user errors.

22 Jun 2010

Lack of tracking of medical devices' performance raises questions about safety and efficacy

"Amid the booming use of artificial joints in the United States, the breakup between Dr. Berger and Zimmer highlights what experts say is a troubling situation for patients and doctors: when disputes arise about orthopedic implant safety, there are no independent referees or sources of information because no one tracks the performance of the devices.

22 Jun 2010

Standard X-rays can help physicians diagnose laparoscopic adjustable gastric band slippage: Study

Standard radiography (X-rays) can help physicians diagnose laparoscopic adjustable gastric band slippage, a known complication of adjustable gastric banding surgery, according to a study published in the July issue of the American Journal of Roentgenology. Adjustable gastric banding surgery is a widely used bariatric surgical procedure to induce weight loss in morbidly obese individuals.

22 Jun 2010

FDA grants approval for newest version of OnGuard Chest X-ray CAD technology

Riverain Medical announced today that the U.S. Food and Drug Administration has granted approval for the newest version of the OnGuard Chest X-ray Computer-Aided Detection technology. OnGuard identifies solitary pulmonary nodules that may represent early-stage lung cancer on an existing chest X-ray. This improved performance demonstrates a 73% reduction in false positive marks and 50% higher relative sensitivity compared to the original product.

22 Jun 2010

OrbusNeich's Genous Bio-engineered R stent shows safety for percutaneous treatment of coronary artery stenosis

OrbusNeich today announced that six-month clinical follow-up data show the safety and efficacy of the combination of pre-dilatation with a paclitaxel drug-eluting balloon (Sequent Please®, B.Braun) followed by implantation of the company's Genous Bio-engineered R stent for the percutaneous treatment of coronary artery stenosis.

22 Jun 2010

Four-year clinical study results show sustained effect that Rheos System has on reducing hypertension

CVRx, Inc. announced today the four-year Rheos clinical results from the European study evaluating the Rheos System at the European Society of Hypertension 20th Meeting. The system is the first device designed to treat hypertension (high blood pressure), a leading cause of heart and kidney disease, stroke and death. This device is a future treatment option for the millions of people who cannot control their blood pressure with medications.

22 Jun 2010

ASIR technique reduces already low radiation dose delivered during CTC by another 50%: Study

A newly adapted low-dose computed tomography technique called adaptive statistical iterative reconstruction can help radiologists reduce the already low radiation dose delivered during CT colonography by another 50 percent, according to a study published in the July issue of the American Journal of Roentgenology.

22 Jun 2010

FDA approves ARCHITECT HIV Ag/Ab Combo assay to aid in diagnosis of HIV-1/HIV-2 infection

The U.S. Food and Drug Administration today approved the first assay to detect both antigen and antibodies to Human Immunodeficiency Virus. This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults including pregnant women. It is also the first assay for use as an aid in the diagnosis of HIV-1/HIV-2 infection in children as young as two years old.

22 Jun 2010

Angeion launches new TRUcal resting metabolic rate system

Angeion Corporation announced that it has launched its new TRUcal™ resting metabolic rate system. Part of its New Leaf® product line, TRUcal includes an analyzer that gently measures one's breath for oxygen and carbon dioxide which gives consumers their true individualized daily calories their body requires. The TRUcal™ system also includes a compact netbook with Bluetooth® technology, adding the benefit of wireless connectivity.

21 Jun 2010

Millar, Telemetry Research partner to offer TRM53P implantable transmitters

Millar Instruments, Inc., a medical device manufacturing firm and developer of pressure sensing technology, has released the TRM53P implantable transmitter through the partnership with Telemetry Research, Ltd. The TRM53P is the world's first, fully implantable transmitter that combines Millar's gold standard solid-state pressure sensors with Telemetry Research's next generation telemetry technology.

21 Jun 2010

Positron sells four Attrius PET scanners

Positron Corporation, a leader as a molecular imaging and solutions company specializing in the field of Nuclear Cardiology, announces the sales of four Attrius™ PET scanners to prominent cardiology practices and orders six Attrius™ PET scanners from its joint venture, Neusoft Positron Medical Systems for immediate delivery.

21 Jun 2010

CareGroup Healthcare System to implement InterSystems Ensemble rapid integration, development platform

InterSystems Corporation, the global leader in software for connected healthcare, today announced that CareGroup Healthcare System, a Boston-based integrated delivery network (IDN) comprised of four hospitals, has selected the InterSystems Ensemble® rapid integration and development platform to replace its legacy eGate platform for strategic integration throughout the organization.

21 Jun 2010

CardioGenics announces clinical test sites for QL Care portable blood analyzer

CardioGenics Holdings Inc., developer of the ultra-sensitive QL Care™ Point-Of-Care (POC) analyzer and products for the immunoassay segment of the In-Vitro Diagnostics market, announced the selection of four sites for clinical testing of its patented QL Care™ Analyzer, a portable diagnostic platform designed to produce test results with central lab-like accuracy in 15 minutes using whole blood.

21 Jun 2010

Boston Scientific adds 22 new balloon sizes to PolarCath Peripheral Dilatation System

Boston Scientific Corporation today announced that 22 new balloon sizes have been added to the PolarCath® Peripheral Dilatation System, including balloon lengths of 120 and 150 mm. The PolarCath System is used to restore blood flow in patients with critical limb ischemia (severe blockages in the arteries below the knee) and blockages in the femoral and popliteal (behind the knee) arteries. Both conditions result from peripheral artery disease.

21 Jun 2010

FDA approves Abbott's ARCHITECT HIV Ag/Ab Combo assay

Every nine and a half minutes, someone in the United States is infected with HIV, and one out of every five of these individuals doesn't know it. To help stem the spread of this disease, the U.S. Food and Drug Administration (FDA) today approved an innovative new diagnostic tool, which will allow patients to be diagnosed earlier than ever before.

21 Jun 2010

Device / Technology News

Biodesix awarded US patent for VeriStrat serum test

Surveillance colonoscopy is effective when targeted to high-risk patients: Study

Biotage launches ISOLUTE SLE+ sample preparation columns

KYPHON ActivOs 10 Bone Cement with HA launched to treat patients with VCFs

FDA to hold workshop on medical device innovation to address unmet public health needs

Research article sheds light on liability concerns and electronic health records systems

Lack of tracking of medical devices' performance raises questions about safety and efficacy

Standard X-rays can help physicians diagnose laparoscopic adjustable gastric band slippage: Study

FDA grants approval for newest version of OnGuard Chest X-ray CAD technology

OrbusNeich's Genous Bio-engineered R stent shows safety for percutaneous treatment of coronary artery stenosis

Four-year clinical study results show sustained effect that Rheos System has on reducing hypertension

ASIR technique reduces already low radiation dose delivered during CTC by another 50%: Study

FDA approves ARCHITECT HIV Ag/Ab Combo assay to aid in diagnosis of HIV-1/HIV-2 infection

Angeion launches new TRUcal resting metabolic rate system

Millar, Telemetry Research partner to offer TRM53P implantable transmitters

Positron sells four Attrius PET scanners

CareGroup Healthcare System to implement InterSystems Ensemble rapid integration, development platform

CardioGenics announces clinical test sites for QL Care portable blood analyzer

Boston Scientific adds 22 new balloon sizes to PolarCath Peripheral Dilatation System

FDA approves Abbott's ARCHITECT HIV Ag/Ab Combo assay

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