Epix Pharmaceuticals (Cambridge, Massachusetts), a developer of pharmaceuticals for MRI, reported the publication of results of the first and second of four MS-325 (gadofosveset trisodium) Phase III clinical trials, MS-325-12 and MS-325-13, in the July and September issues of Radiology. The articles indicate that MS-325, a contrast agent designed specifically for vascular imaging with magnetic resonance angiography (MRA), provides higher quality images of the aortoiliac vessels resulting in better agreement with X-ray angiography, the standard of reference, than non-contrast MRA. MS-325 is being co-developed by Epix and Schering (Berlin).
Inovise Medical (Portland, Oregon) reported the introduction of Audicor 200, its next-generation combination heart sound and electrocardiogram technology intended for the diagnosis of heart failure and acute myocardial infarctions by paramedics. Weighing less than a pound, the portable Audicor 200 is the first diagnostic to help paramedics in the confident diagnosis of shortness-of-breath in patients with subtle signs and symptoms of heart failure. The company said its Audicor technology accurately detects, interprets, and documents the presence of an S3, a highly specific indicator of left ventricular dysfunction, helping lead to the faster diagnosis, appropriate treatment and better clinical outcomes.
Longport (Glen Mills, Pennsylvania), a medical technology specialist in high-resolution ultrasound imaging, reported the development of additional dermatology probes for its Episcan-I-200 system. The new probes, which are fully compatible with the Episcan-I-200 system, can be used in aesthetics (assessing the impact of many procedures on skin aging), dermatology (skin lesion mapping to guide surgical and other procedures and general dermal assessment), scar assessment and to aid the development of skin orientated medical devices and pharmaceutical products. The Episcan currently uses ultrasound probes optimized to detect the early development of pressure ulcers. These probes use ultrasound at center frequency of 20MHz and are designed to image the approximately 10 mm of soft tissue that is normally found over the bony prominences of the most comment pressure ulcer sites. Comparative images from different frequency probes can be viewed and downloaded from Longport's web site. Longport expects to launch these new ultrasound probes into the U.S. market in 4Q05.
Masimo (Irvine, California) said the FDA has cleared the Masimo SET (Signal Extraction Technology) LNOP Blue sensor, which the company termed "an important milestone for care of cyanotic infants and children." The clearance of the sensor is for measuring the oxygen saturation of arterial blood (SpO2) in pediatric, infant and neonatal patients with congenital cardiac lesions. Due to what it termed "the unique physiology and critical condition of these patients," Masimo said "accurate monitoring of SpO2 has not been possible." Prior to the introduction of the SET LNOP Blue sensor, it said pulse oximeters' inaccuracies were as high as 15% on cyanotic patients. Masimo said its new sensor has an accuracy of 3% in the 80% to 100% oxygen saturation range and accuracy of 4% in the 60% to 80% oxygen saturation range. Peter Cox, MD, clinical director of the pediatric intensive care unit at The Hospital for Sick Children (Toronto), said, "This new sensor has remarkable precision and accurately tracks the arterial oxygen saturation to low levels. In the past, oximeters have been inaccurate in this range." Masimo said the LNOP Blue sensor is the first sensor to receive accuracy claims for cyanotic infants and children.
Toshiba America Medical Systems (TAMS; Tustin, California) has introduced the Famio ultrasound system, a high-end, gray-scale 2-D system. TAMS said, "superior image quality is achieved through Famio's smart technologies, including the Digital Continuous Beam Former and Tissue Harmonic Imaging." The company said the compact and mobile design of Famio "is ideal to suit the needs of physician office settings, where space is at a premium." The system includes ergonomically designed transducers for "optimal sensitivity and resolution from near to far field in any clinical situation," and TAMS said its plug-and-play feature ensures the system can immediately contribute to the productivity of the practice.