• Acusphere (Baltimore) reported the completion of enrollment in the second of its two Phase III clinical trials, RAMP-2 (Real-time Assessment of Myocardial Perfusion-2), for the company's lead product candidate, AI-700. AI-700 is an investigational ultrasound contrast agent designed to assess myocardial perfusion. Currently there is no approved ultrasound contrast agent to assess blood flow to the heart muscle. The company said it anticipates making a public announcement regarding the RAMP-2 trial results in 4Q06. Separately, the company reported results for the RAMP-1 clinical trial and an intellectual property license with GE Healthcare (Waukesha, Wisconsin). The company's trials of AI-700 are designed to demonstrate that stress echo with AI-700 is non-inferior to nuclear stress testing in the detection of coronary heart disease.

• Biophan Technologies (Rochester, New York) reported that the U.S. Patent and Trademark Office recently issued the company two new patents. The patents are for methods of signaling the heart, which improve the function of implanted cardiovascular devices. The first, U.S. patent No. 7,020,517, teaches a means of detecting and responding in a manner that avoids the onset of ventricular fibrillation. The method uses a low voltage electrical signal, which can be built into a low cost pacemaker and provide some protection against fibrillation events. The technology can also be deployed in a cardio-defibrillator as a means of controlling fibrillation to avoid the need for the 800-volt charge traditionally used in implantable defibrillators. The second patent, U.S. patent No. 7,054,686, teaches use of a high frequency pulse sequence in place of a single pacing signal so that stimulation of the heart can occur with lower energy, a technique with the potential to improve battery life of implantable devices.

• Boston Scientific (Natick, Massachusetts) reported that it has received FDA clearance to launch its Sterling Monorail and Over-the-Wire Balloon Dilatation Catheter in the U.S. The balloon catheters are available in a broad range of sizes. Both balloon catheter platforms are engineered for use in the renal and lower extremity arteries, as well as in dialysis fistula. In addition, the Sterling Monorail Catheter received a specific indication for use in the carotid arteries as both a pre- and post-dilatation balloon. The Sterling Balloon Dilatation Catheter features an ultra-low profile balloon (4 Fr), designed to meet the challenges of the peripheral vasculature. Its refined profile is complemented by a balanced shaft featuring seamless transitions, which the company said is designed to offer clinicians enhanced trackability and powerful push when faced with traversing challenging anatomy.

• Cepheid (Sunnyvale, California), a broad-based molecular diagnostics company, reported the European release of the Smart VZV Assay for clinical diagnostic use on the SmartCycler System. The VZV assay was released as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Smart VZV is intended for rapid detection of the varicella-zoster virus, a member of the herpes virus subfamily. Cepheid's Smart VZV delivers a positive or negative result in under an hour after DNA extraction.

• Clinical Data (Newton, Massachusetts), a provider of comprehensive molecular and pharmacogenomics services as well as genetic tests, reported that its PgxHealth division will provide a genetic test to clinicians that is associated with response to warfarin, a commonly prescribed drug to treat and prevent blood clots. The company has been granted commercialization rights relating to certain polymorphisms in the Vitamin K epoxide reductase complex gene (VKORC1). Polymorphisms within the VKORC1 gene are one of the important predictors of response to warfarin. The company said the genetic test for warfarin response should, when combined with certain clinical information, explain or predict more than 50% of the variability in response to warfarin. The company anticipates that PGxHealth will make this test commercially available by the end of the year.

• Digirad (Poway, California), a provider of cardiovascular imaging services and solid-state nuclear medicine imaging products, reported the release of the new Cardius 3 XPO triple-head cardiac gamma camera at the Society of Nuclear Medicine meeting in San Diego. The Cardius 3 XPO imaging system introduces Solidium high-definition solid-state digital detector technology, a new design that allows imaging of patients weighing up to 500 pounds and offers up to 38% faster image acquisition times than conventional dual head systems. The company said the Cardius 3 XPO delivers more patient comfort, enhanced clarity of diagnostic results, achieving greater imaging speed and producing images of superb quality.

• Estech (San Ramon, California) reported the market launch of AFfirm, an atrial fibrillation (AF) conduction block verification probe. AFfirm assesses the effectiveness of cardiac ablation treatments, which create new electrical paths in the heart, resulting in improved cure rates. The pacing probe's flexible design allows easy access to treatment sites, including minimally invasive or stand alone treatments for AF.

• GE Healthcare (Waukesha, Wisconsin) said data from two recent studies comparing bone densitometers found that the GE Lunar Prodigy has lower precision error when measuring changes in bone mineral density (BMD). The Prodigy uses direct-digital technology that has been proven to have better precision for BMD testing in the detection of osteoporosis. The two studies were presented earlier this week at the International Osteoporosis Foundation World Congress on Osteoporosis in Toronto. In the first study, BMD was measured with the Lunar Prodigy and another system in 20 women aged 59 to 65 years. The authors found that precision at the femur, a critical fracture site, was significantly better with the Prodigy. In the second study, a total of 31 women aged 54 to 77 years were measured. This study concluded that BMD precision error with the Lunar Prodigy was significantly lower than the other system at both the femur and spine.

• Telzuit Medical Technologies (Orlando, Florida) reported that it has successfully tested a prototype of its wireless heart monitor using Bluetooth technology delivered by Cambridge Silicon Radio's (Cambridge, UK) BlueCore3. The integration of the Bluetooth component signifies the final step in the development of Telzuit's flagship 12-lead wireless heart monitor, readying the product for its initial production run and positioning it for formal launch in 2006. The completion of this prototype also clears the way for final development and implementation of the company's other mobile medical devices, including an FDA-approved 12-lead wireless cardiac event monitor; a home sleep apnea test; and a long-term care patient solution incorporating the company's core wireless technology.

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