American Bio Medica (ABMC; Kinderhook, New York), a manufacturer of immunoassay diagnostic test kits, said that the FDA has granted the company 510(k) clearance on its Rapid Reader, a personal computer peripheral that interprets, scans, transmits, records and stores the results of ABMC drug screens. As the first FDA-cleared all-inclusive drug screen result interpretation and data management system, the Rapid Reader is a compact, portable device that, when connected to any computer, captures a picture of the test results on an ABMC drug screen using a high resolution camera. The Rapid Reader's software analyzes this image and interprets the results. The information is then sent to a data management system, which enables the user to interpret, store, transmit and print the drug test results.
Clinical diagnostics company Dade Behring (Deerfield, Illinois) said that its Dimension Vista 1500 integrated system, which will be the company's first integrated chemistry/immunochemistry system targeted at high volume clinical laboratory customers, has received 510 clearance from the FDA. This is the first of a series of submissions and approvals prior to the anticipated commercialization of the Dimension Vista system in the second half of 2006. The Dimension Vista 1500 integrated system will combine photometry, turbidemetry, nephelometry, integrated multisensor technology and LOCI technologies. The new design will integrate analysis of electrolytes, general and special chemistries, drugs-of-abuse, therapeutic drugs, immunosuppressive drugs, plasma proteins, cardiac marker tests and high-sensitivity immunoassays into one analyzer.
DOBI Medical International (Mahwah, New Jersey) said that it has entered into contracts with 17 U.S. sites in connection with its clinical trial studying its ComfortScan system. The ComfortScan system has been installed in 16 of those sites, and other locations will receive systems in the near future. The clinical trial is the final element of the company's premarket approval application to the FDA. The ComfortScan system is designed as an adjunct to screening mammography to aid in breast cancer diagnosis. It is a non-invasive, non-ionizing device that uses light-emitting diodes, sophisticated imaging processing and display software, and gentle external pressure to identify angiogenesis in the breast. Angiogenesis has been widely linked with the growth and development of malignant tumors, the company said.
Envisioneering Medical Technologies (St. Louis), a manufacturer of diagnostic and treatment technology, said a recent study confirms that TargetScan, a new FDA-approved targeted prostate biopsy and cancer treatment system, delivers improved biopsies for the detection and treatment of prostate cancer. According to the study performed at Washington University (St. Louis), TargetScan's application of a stationary probe with 3-D image acquisition provided better biopsy information about the location, extent and aggressiveness of prostate cancer compared to conventional biopsy techniques. For patients, these findings mean that a TargetScan biopsy may lead to improved cancer detection and more accurate prognoses, the company said. The clinical test showed that TargetScan detected cancer more frequently upon the first biopsy than over conventional biopsy techniques. Additionally, the researchers suggested that TargetScan's stabilized probe coupled with its ability to reproduce biopsies and intraprostatic needle localization could improve the success of new cancer-treatment deliveries, such as brachytherapy and cryotherapy.
Karl Storz Endoscopy-America (Culver City, California) launched its Flex-X2 Uretero-Reno-Fiberscopes during this year's American Urological Association Annual Meeting in San Antonio. The company said the Flex-X2 Uretero-Reno-Fiberscopes offer increased resistance to laser damage during use, which has become all too common an occurrence during surgeries. Like its predecessor, the Flex-X2 offers active 270-degree up and down deflection with intuitive single-lever control. By enhancing complex navigation and adapting to a range of anatomical shapes, the Flex-X2 Uretero-Reno-Fiberscope eases entry into the lower pole calyces and the entire renal collecting system. An ergonomically designed handle combined with the device's light weight offers greater operating comfort, and the 7.5 Fr distal shaft gives physicians easy access during procedures. A stiffer 8.5 Fr shaft is engineered from proprietary polymers to promote faster, easier passage of the uretero-reno-fiberscope.
North American Scientific (Chatsworth, California) reported that its Nomos Radiation Oncology division has received FDA 510(k) clearance to market nTRAK, its new stereotactic image guidance system used to position and monitor patients during radiation therapy treatments for head and neck cancers. The nTRAK system uses an optical camera and fiducial markers attached to a customized bite block to provide assurance that a patient is positioned reproducibly within required tolerances throughout a course of radiation therapy treatments. The company expects sales of nTRAK to begin in the fourth quarter of fiscal 2005. The nTRAK system consists of a newly designed mouth bite and trackers, a new radiotherapy table adapter, ceiling-mounted optical camera and treatment room console. nTRAK also incorporates a study review feature that allows the physician to review the treatment session to determine if modifications to the treatment fields or immobilization system are warranted.
Novadaq Technologies (Toronto), which is developing medical devices based on its imaging platform for the diagnosis and treatment of vascular and ophthalmic conditions, said that it has been granted a patent by the United States Patent and Trademark Office for the SPY Intra-operative Imaging System. The FDA-cleared SPY System enables real-time visual confirmation of revascularization during heart bypass surgery, which the company said allows bypass graft technical errors to be detected and corrected while the patient is still in the operating room. U.S. patent No. 6,915,154 B1, "Method and apparatus for performing intra-operative angiography," describes the SPY intra-operative fluorescent imaging system that enables cardiac surgeons to confirm the location of coronary arteries during coronary artery bypass graft procedures and visually assess and validate the functionality of bypass grafts.
Roche Diagnostics (Indianapolis) reported that it has received FDA clearance for its Elecsys PreciControl Tumor Marker control solution. The tumor marker provides laboratory professionals with the same control for six different tumor marker tests. The Elecsys PreciControl Tumor Marker control adds to Roche Diagnostics' growing tumor marker portfolio that includes prostate-specific antigen; free prostate-specific antigen; Alpha-fetoprotein; carcinoembryonic antigen, CA-15-3, which monitors treatment of breast cancer and recurrences; and CA-125, which monitors the treatment of ovarian cancer. Because one control can be used with all of the tests, laboratory professionals could see an increase in efficiency and productivity — there is no need to switch controls in order to run different tests. Roche Diagnostics has filed a submission with the FDA for its Elecsys CA 19-9 assay, and that submission is pending.