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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

Al Amal Hospital in Qatar commences treatment with Varian's RapidArc radiotherapy

One of the leading cancer centers in the Middle East has become among the first in the region to introduce fast and efficient RapidArc® radiotherapy treatments from Varian Medical Systems. Al Amal Hospital in Doha, Qatar, has treated nine brain cancer, prostate cancer and head & neck cancer patients with RapidArc since commencing treatments in early May, and it now plans to roll out the technology for many more indications.

21 Jun 2010

Keane Healthcare Solutions Division announces partnership with Ormed Information Systems

Keane, Inc., a U.S.-based IT services and healthcare technology firm, today announced a partnership between its Healthcare Solutions Division (HSD) and Ormed Information Systems, Ltd. against the backdrop of the Healthcare Financial Management Annual National Institute conference (HFMA ANI). Ormed is a leading supplier of human resources, supply chain, E-commerce, and accounting management software, and is entering their 21st year in supporting only the healthcare industry.

21 Jun 2010

Emdeon's Assistant, Claim Master solutions earn HFMA Peer Reviewed designation

Emdeon Inc., a leading provider of healthcare revenue and payment cycle management solutions, today announced that its automated patient eligibility and benefits verification tool, Emdeon® Assistant™, and web-based billing management solution, Emdeon Claim Master®, have earned the Peer Reviewed designation of the Healthcare Financial Management Association (HFMA). The HFMA Peer Reviewed designation places these Emdeon solutions on a short list of prestigious products that have been proven effective by industry expert volunteers and independent HFMA staff.

21 Jun 2010

Saladax Biomedical, Bristol-Myers Squibb collaborate to develop clinical diagnostics

Saladax Biomedical, Inc. announced today that it has entered into a multi-year development and commercialization agreement with Bristol-Myers Squibb Company for the development of certain clinical diagnostic tests to be used in conjunction with the development of certain therapeutic compounds in the Bristol-Myers Squibb pipeline.

21 Jun 2010

Device / Technology News

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

Al Amal Hospital in Qatar commences treatment with Varian's RapidArc radiotherapy

Keane Healthcare Solutions Division announces partnership with Ormed Information Systems

Emdeon's Assistant, Claim Master solutions earn HFMA Peer Reviewed designation

Saladax Biomedical, Bristol-Myers Squibb collaborate to develop clinical diagnostics

Redefining control and consistency in anaerobic microbiome workflows

AI in Healthcare: How generative tools are transforming clinical practice

The future of automation: Machine learning–driven hepatocyte and organoid counting

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