Biosite (San Diego) said the FDA has accepted the company's Triage Stroke Panel premarket approval application (PMA) for further review. The panel is intended for use as an aid in the assessment and diagnosis of cerebral ischemia, or stroke. The Triage Stroke Panel consists of multiple biomarkers and uses a proprietary algorithm to calculate a single MultiMarker Index result. Biosite submitted its PMA for the Triage Stroke Panel in December. Existing methods to diagnose stroke and confirm symptoms utilize radiographic imaging, such as computed tomography, which are subject to interpretation and often unable to detect the most common form of stroke until 12 to 24 hours after an event. Currently in the U.S., there is no rapid, in vitro diagnostic test using protein markers from a blood sample commercially available for use as an aid in the diagnosis of stroke.
Glucon (Boulder, Colorado), developer of a continuous, non-invasive, glucose monitoring technology for home and clinical use, said it has been granted U.S. patent No. 6,846,288 for the use of photoacoustic waves originating in a specific region (a blood vessel) to calculate the concentration of a component (glucose) in the blood vessel. Glucon's flagship device, the Glucose Monitoring Watch, displays a continuous reading of the patient's real time blood glucose level, enabling the patient to take the necessary measures to treat their condition. Ultrasound imaging is employed to identify a blood vessel and optical spectroscopy is used to quantify the glucose concentration within the blood vessel.
Karl Storz (Culver City, California) has launched its Telecam DX II camera control unit (CCU) to address the market for office-based video endoscopy systems. The company said the Telecam DX II CCU enables physicians to provide high-quality patient care while maintaining cost efficiency. It said the new system is particularly well suited to ob/gyn, urology and ENT practices. The DX II has been designed to enhance image quality, adaptability and the degree of control the physician has over the system. It relies on fiberscope filters to remove moire patterns and pixelation from images generated by flexible telescope scopes. Precise auto-exposure and brightness control are used to maximize the quality of every image. Interchangeable adapters for the Telecam DX II are available in 12 mm, 25 mm, 30 mm and 38 mm focal lengths. Programmable buttons give the physician control over as many as four camera functions directly from the camera head. The system's freeze-frame capability allows the physician to freeze images for discussion with patients or colleagues, or for diagnostic interpretation.
Medtox Scientific (St. Paul, Minnesota) said it has filed a 510(k) application with the FDA for clearance to market its Sure-Screen drugs-of-abuse point-of-collection test device. Sure-Screen is intended to provide lower detection levels for eight commonly abused drugs. Sure-Screen will provide lower detection levels on eight drugs (marijuana, opiates, cocaine, amphetamines, methadone, benzodiazepines, methamphetamines and MDMA (Ecstasy) by an average of about 50% each. The company said it believes there is a demand for lower detection levels in certain markets, including probation, parole, rehabilitation, hospital emergency departments and corporate clients interested in lower detection levels for pre-employment testing.
Neoprobe (Dublin, Ohio), a developer of oncology and cardiovascular surgical and diagnostic products, said it has received notification that its 510(k) application for the revised and enhanced Quantix/OR blood flow measurement has been accepted by the FDA for review. In addition, Neoprobe said it has completed the necessary regulatory steps to begin marketing the product in the European Union. The company reintroduced the Quantix/ OR at a joint meeting of the German, Austrian and Swiss cardiovascular surgical society meeting in Hamburg, Germany, last weekend. The Quantix/OR has been revised to enhance visual ergonomics and to facilitate surgeon use. The flexible probe configuration will permit surgeons to access vessels for measurement during both on- and off-pump by-pass procedures. The company said it is planning full product re-introduction at the American Association for Thoracic Surgery meeting in April.