Abbott (Abbott Park, Illinois) reported the availability of an automated hepatitis C virus (HCV) test in the U.S. for its AxSYM automated immunoassay instrument system, and providing results within 23 minutes. The presence of antibodies to HCV indicate that an individual may have been infected with HCV in the past or have an ongoing infection. A microparticle enzyme immunoassay test, the AxSYM Anti-HCV test is designed for the qualitative detection of antibodies to HCV in human serum or plasma and is not intended for use in blood, plasma or tissue screening. Last year in the U.S., Abbott introduced two automated tests for the hepatitis A virus on the AxSYM system AxSYM HAVAB-M 2.0 assay and AxSYM HAVAB 2.0. The company also has submitted an application to the FDA for its AxSYM hepatitis B tests, which currently are available outside of the U.S. The hepatitis tests are used for blood screening and diagnostic testing.

Biofield (Atlanta) said the FDA has conducted a review of the company's request for reclassification of the Biofield Breast Proliferation Rate Detection System that is intended as an adjunct to support other modalities such as mammography, clinical breast exam, sonography and MRI used in breast cancer diagnosis. The FDA determined that its device does not meet the criteria for Class I (General Controls) or Class II (Special Controls) classification and therefore falls into Class III, for which 510(k) clearance does not apply. Approval must instead be sought through a premarket approval (PMA) application. David Long Jr., MD, PhD, chairman and CEO, said the company intends to meet shortly with the FDA to discuss regulatory pathways and data requirements. "The company plans to cooperate with the FDA in this process of moving forward under the format of a PMA," he said.

Criticare Systems (Milwaukee), which designs patient monitoring systems and non-invasive sensors for hospitals and other healthcare environments, reported the release of a new technology platform for non-invasive blood pressure (BP) measurement using a traditional BP cuff. The system adds a greater level of patient comfort, safety, accuracy, reading speed and tolerance of a range of physical and environmental conditions. Its gentler pressure feature addresses all patients, but in particular, reduces a potentially painful experience when used on children and the elderly. Criticare said it believes it is one of the first patient monitoring companies worldwide to adhere to both U.S. and European standards for validation of blood pressure measuring devices. The technology is now in production at Criticare and also will be offered on an OEM basis.

Imcor Pharmaceutical (San Diego), which is developing a platform of imaging products, reported that the Hong Kong Patents registry issued a notification of allowance for a patent directed to the composition of matter for forming stabilized microbubbles using perfluorocarbons and other gases in various membrane-forming materials.

Inverness Medical Innovations (Waltham, Massachusetts) and its subsidiary, Wampole Laboratories (Princeton, New Jersey), reported the availability of a new fecal occult blood (FOB) test, the Clearview Ultra FOB Test, which they said offers significant advances over existing tools used to screen for colorectal cancer. The Clearview Ultra FOB Test is a rapid, two-step immunoassay test for the detection of fecal occult blood. Accurate results are available in less than five minutes and only one sample from the patient is needed. The test does not require the patient to adhere to a restricted diet, which they company said may lead to better compliance. The new test utilizes the proprietary Inverness lateral flow technology, which detects human hemoglobin in a fecal specimen.

IVMD (Inverness, Scotland) reported the results of recent clinical trials conducted in connection with its labor prediction device. When used in the home by healthy pregnant women, it was found to provide an overall prediction of the onset of normal labor from 14 to seven days in advance. The company said independent studies have shown that the uterus spends time, before the actual birth, getting ready for the labor process and IVMD's predictive technology interprets this physiology with a small electrode system placed on the abdomen and an electronic recording device. Expectant mothers record electrical activity from the uterus for 10 minutes every day from 30 weeks on. The signals detected can be used to predict the onset of labor. These trials, undertaken with 60 women in the UK, were concluded in October 2004. IVMD Chief Science Officer Patricia Connolly said the results "give a clear indication that we can measure the changing physiology of the uterus and create a predictive tool. ... and from future analysis, there may be other parameters that can make our system even more accurate."

JMAR Technologies (San Diego) said it has been issued U.S. patent No. 6,845,145 B2 for advanced X-ray lithography stepper technology that will enable a faster, more cost-effective means of producing zone plate optics for its Compact X-ray Microscope and X-ray Nano Probe product lines. JMAR said the combination of its soft X-ray source and its newly patented stepper creates a "unique tool" for fabrication of the zone plate diffractive optics used to collect and focus X-rays. The zone plate optical elements used in JMAR's new product lines require concentric ring spacing in the sub-100 nanometer range and are currently written using electron beam lithography systems, a time-consuming and costly method, since the thousands of concentric rings comprising the zone plate are written one ring at a time. Using the X-ray lithography stepper technology described in the new patent, JMAR said it plans to write these concentric rings concurrently, resulting in more efficient, economical and consistent production.

Medwave (Danvers, Massachusetts) said that a study recently published in the American Journal of Emergency Medicine compared readings taken with Medwave's Vasotrac non-invasive sensor-based blood pressure monitor against the "gold standard" invasive arterial catheter and a traditional oscillometric blood pressure cuff. The study showed that Medwave's Vasotrac monitor provided advantages over both. Separately, Medwave reported that it has released its new enhanced OEM module developers kit, which allows medical device manufacturers to sample the Medwave blood pressure technology in a development setting without investment in engineering resources or time. The kits will be sold only to device manufacturers registered with the FDA or similar regulatory organizations. Medwave will begin to sell this solution to prospective OEM partners immediately. Medwave developed its original MJ23 OEM module pursuant to an agreement with Nihon Kohden (Tokyo). The new module is named "Legato", which in music refers to a smooth and connected style.

Nanogen (San Diego), developer of advanced diagnostic products, reported that it was issued U.S. patent No. 6,864,071 by the U.S. Patent and Trademark Office. The patent relates to amplifying and analyzing multiple samples of nucleic acid using ligation-based strand displacement amplification (SDA) technologies. The intellectual property pertains to research Nanogen conducted in collaboration with Becton Dickinson (Franklin Lakes, New Jersey) and increases Nanogen's portfolio of technologies for multiplex amplification on a chip. The combination of SDA and Nanogen chip technologies makes it possible to conduct multiplex amplification, detection and analysis of multiple samples within a single electronic microarray. SDA is an isothermal amplification process that uses a series of primers, DNA polymerase and a restriction enzyme to exponentially amplify the target nucleic acid sequence.

Varian (Palo Alto, California) reported the release of its Version 6.5 Mass Spectrometer (MS) Workstation Software that includes CTC Autosampler control for liquid chromatography (LC). The Version 6.5 is a single fully integrated application allowing both gas chromatography (GC)/MS and LC/MS systems to be operated under one standardized platform. Complementing the latest revision of the platform, Varian said it now offers full control of the CTC HTS PAL Autosampler. The company said the MS Workstation SW Version 6.5 provides ease-of-use enhancements for routine LC/MS analysis involving large numbers of samples, such as simplifying routine data review and quantitation of large numbers of data files, enabling the operator to be more productive with large sample loads. In addition, full control of the CTC HTS PAL Autosampler is integrated in the software, allowing the operator to program the autosampler without leaving MS Workstation. The Version 6.5 MS Workstation Software will begin shipping in June.

Vital Images (Minneapolis), a provider of enterprise-wide advanced visualization software, has launched Vitrea 2, Version 3.7, the company's latest software for 2D, 3D and 4D visualization analysis. The new release features Cardiac Functional Analysis and Computed Tomography (CT) Lung options developed by Vital Images. In addition, Version 3.7 includes enhancements to InnerviewGI, the company's CT colon software. Version 3.7, geared to enhance workflow and productivity, is now available for shipment.