Technology | Dave Fornell

The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals to stop using CardioGen-82 for cardiac positron emission tomography (PET) scans. The manufacturer, Bracco Diagnostics Inc., has decided to voluntarily recall CardioGen-82 this week after two patients set off radiation detectors at a U.S. border crossings due to strontium contamination.

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July 26, 2011 – According to the 2011 Top 20 Best in KLAS Awards: Medical Equipment & Infrastructure report, GE Healthcare’s Logiq E9 has been recognized as the top general imaging ultrasound system in the market. In the same report, GE’s Vivid E9 was awarded a share of the top spot for cardiovascular ultrasound systems.

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July 26, 2011 – The first patient has been enrolled in the LEVANT 2 clinical trial, a global, multi-center, randomized trial evaluating the safety and efficacy of Lutonix’s Moxy drug-coated balloon compared with a standard angioplasty balloon for the treatment of peripheral arterial disease (PAD). The first case was performed at St. John's Hospital in Springfield, Ill. by Jeff Goldstein, M.D.

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July 26, 2011 – Cardio Pulmonary Diagnostic LLC in Newark and Hudson County Cardiovascular Care PC in Jersey City, N.J. have selected McKesson’s Practice Complete certified electronic health record (EHR) and practice management system. Built with cloud-computing technology, the integrated solution is designed to help providers improve billing and patient services, assist in accelerating payments and contribute to reductions in information technology costs and regulatory risk.

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July 26, 2011 — Concentric Medical Inc. has launched the DAC 070 Catheter, the fourth and largest diameter addition to its distal access catheter (DAC) family to aid clot removal in ischemic stroke patients.

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July 26, 2011 – The Resolute drug-eluting stent (DES) from Medtronic Inc. showed superiority to Boston Scientific Corp.’s Taxus DES on in-stent late lumen loss at eight months, the primary endpoint of the RESOLUTE Japan clinical study.

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July 25, 2011 —Siemens Healthcare announced that syngo Neuro PBV IR (parenchymal blood volume interventional radiology) has received U.S. Food and Drug Administration (FDA) 510(k) marketing clearance. The software package is intended to provide visual assistance to physicians in the diagnosis and treatment of vessel malformations (such as aneurysms, arteriovenous malformations and stenoses).

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July 25, 2011 — Cardiac Science Corp., manufacturer of automated external defibrillators (AEDs) and diagnostic cardiac monitoring devices, announced the new capability of direct communication between its HeartCentrix connectivity solution and the GE Healthcare Centricity EMR system.

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July 25, 2011 — Memorial Hospital of South Bend, Ind., installed the 100th Philips interventional X-ray system with electrophysiology (EP) cockpit XL. The system includes an Allura Xper FD 10, EP cockpit workflow solution and EP navigator cardiac visualization tool.

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The U.S. Food and Drug Administration (FDA) said it is amending the classification regulation for electrocardiograph (ECG) electrodes into a class II device category, exempting these devices from FDA clearances. This rule is effective as of Aug. 22, 2011.

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July 21, 2011 – The U.S. Food and Drug Administration (FDA) today approved AstraZeneca’s blood-thinning drug ticagrelor (Brilinta) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS). The new class of antiplatelet therapy drug offers greater benefits over the current standard of clopidogrel (Plavix). The new drug is also the first with the ability to have its effects reversed quickly, reducing bleeding complications if a patient requires surgery or suffers trauma.

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July 21, 2011 – Concentric Medical Inc. announced the launch of the expanded family of Merci Retrievers in Japan for the treatment of ischemic stroke. With the addition of the V 2.0 Soft and V 3.0 Soft, through recent Ichihen Approval, the entire family of V Series Merci Retrievers are now approved and reimbursed in Japan. The Merci Retriever is a catheter-based medical device that stroke centers use to remove blood clots from the brains of patients suffering an ischemic stroke.

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July 20, 2011 –ScImage recently launched PicomCloud, a complete, self-service cloud picture archiving and communication system (PACS) for radiology, cardiology and other clinical specialties.

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July 20, 2011 — IDEV Technologies Inc. announced the completion of enrollment in the SUPERB trial, a U.S. Food and Drug Administration (FDA)-approved IDE trial evaluating the use of IDEV's Supera stent system for treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA). Enrollment was completed in May, making SUPERB one of the fastest-enrolling SFA trials.

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July 20, 2011 — Ziehm Imaging reports a huge increase in demand for its training programs. In 2010 alone, the number of participants doubled for technical courses given by the mobile C-arm manufacturer.

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