July 25, 2008 - The FDA granted 510(k) approval in June for numerous diagnostic and invasive cardiac devices, including both new devices and modified versions of existing equipment. Among the approvals were the following devices:

- CryoCath Technologies Inc. had its FlexCath Steerable Sheath and intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning. It was previously approved to facilitate placing a catheter through the skin into the artery or vein.

July 25, 2008 – In an amended collaboration with Biosense Webster Inc., Stereotaxis Inc.’s partner in the development of ablation catheters used with its Niobe Magnetic Navigation System, Biosense Webster will provide Stereotaxis a total of $18 million, comprised of advances against royalties on catheter sales and deferrals of ongoing research and development costs in connection with current and future products.

July 25, 2008 - The cardiac transplant team from St. Vincent’s Hospital in Sydney, Australia, will travel to Paris July 28-29 to begin the first phase of certification training for the CardioWest temporary total artificial heart (TAH-t).

July 25, 2008 - Inverness Medical Innovations Inc. and Thermo Fisher Scientific have extended their cardiology products distribution relationship by two years through December 2010, which covers all cardiology and drugs of abuse rapid test products manufactured by Inverness’ subsidiary Biosite.

These tests are sold under the Triage brand and include tests for BNP, troponin, CK-MB, Myoglobin, d-dimer and a broad range of meter and visually read drugs of abuse tests.

July 24, 2008 - Philips has a new addition to its HD ultrasound family of products, the Philips HD15 ultrasound system, which is designed to provide physicians with high-end imaging and workflow performance in a cost-effective system.

July 24, 2008 - According to a new Life Science Intelligence (LSI) report, “2008 Global Vascular Closure Device Markets: U.S., Europe, Rest of World,” the global market for vascular closure devices will reach nearly $1 billion in 2013.

July 24, 2008 - The FDA has granted clearance for GE Healthcare’s newest positron emission tomography/computed tomography (PET/CT) scanner, which is part of GE’s Discovery family of scanners designed to enable earlier detection and monitoring of disease with advanced molecular imaging technology in both hardware and software.

July 24, 2008 - FluoroPharma said it achieved positive phase I test results for BFPET, a novel Fluorine-18 labeled tracer for PET myocardial perfusion imaging.

BFPET is designed to assess the blood flow in the heart (myocardial perfusion), which is a standard test to assess coronary artery disease (CAD), with more than 9 million Americans undergoing the test annually.

July 24, 2008 – Covidien recently launched the Optistar Elite contrast delivery system, designed to inject contrast media-related drugs into a patient’s vascular system to aid in obtaining diagnostic images when used with magnetic resonance (MR) imaging equipment.

The product recently received FDA approval and already carries a CE Mark.

The Optistar Elite aims to provide improved performance and ease of use, compared with the previous Optistar LE model.

Philips has a new addition to its HD ultrasound family of products, the Philips HD15 ultrasound system, which is designed to provide physicians with high-end imaging and workflow performance in a cost-effective system.

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