The FDA cleared for marketing a new automated version of diaDexus’ proprietary PLAC Test, an automated immunoassay designed to run on common existing laboratory equipment, including clinical chemistry analyzers from Hitachi, Roche/Hitachi and Olympus, expanding the number of clinical labs and physician offices that are able to offer the PLAC Test.

Textronics Inc. received FDA clearance to market its textile-based ECG Electrode for use in general electrocardiograph monitoring and recording procedures, offering patients an alternative to adhesive electrodes and metal wristbands.

Boston Scientific’s IQ Guidewire is designed to provide the torque response, side branch access support and device delivery required for a variety of clinical scenarios. The IQ’s core material is linear elastic nitinol, and features a silicone coating.

Abbott Vascular’s HI-TORQUE WHISPER guidewire is designed to offer a higher level of support to facilitate device delivery. The smooth parabolic profile tracks around bends, reportedly allowing access to even the most distal tortuous lesions, and eliminates prolapse points and minimizes kinking.

The HI-TORQUE features high tensile strength core material, reportedly yielding favorable torque response and wire durability. The core-to-tip design aims for outstanding steering and torque control.

GE Healthcare launched its new mobile Vivid S5 cardiovascular ultrasound system, created for multiple care areas, featuring a full sized 17-inch LCD monitor, three active transducer connectors and room for on-board peripherals retained in a miniaturized console weighing less than 160 pounds.

Northeast Monitoring received clearance from the FDA to sell its DR200 Series devices with its automatic atrial fibrillation (Afib) detection solution, enabling the company to link the stand-alone DR200 series, “Tel-a-heart” Event Recorders and the DR200/HE Combination Holter and Event recorders.

The FDA cleared GE Healthcare’s new LightSpeed CT750 HD, said to be the world’s first high definition CT scanner that produces images 100 times faster with up to 33 percent greater detail through the body and up to 47 percent greater detail in the heart.

CT750 HD reduces dose by up to 50 percent across the entire body and by as much as 83 percent for cardiac scans.

Boston Scientific's ALTRUA family of pacemakers is the first Boston Scientific-branded pacemaker to treat bradycardia.

May 9, 2008 - The FDA cleared Boston Scientific's ALTRUA family of pacemakers, a day after the European approval of ALTRUA was announced,launched and received CE Mark approval for its ALTRUA family of pacemakers, which enables the company to introduce its first Boston Scientific-branded pacemaker to treat bradycardia.

May 9, 2008 – The Centers for Medicare and Medicaid Services (CMS) issued its final National Coverage Decision (NCD) to reimburse the CardioWest temporary Total Artificial Heart (TAH-t) as part of FDA studies that meet CMS specifications, marking a reversal of a 1986 National Non-Coverage Decision for the artificial heart.

“Our decision revises a long-standing non-coverage policy and allows beneficiary access to this advanced technology,” said CMS Acting Administrator Kerry Weems. “Our decision also encourages the completion of FDA post-approval studies.”

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