• Abaxis (Union City, California) said that the FDA has granted waived status under CLIA regulations for 4 additional analytes, that subsequently allows the waived status of 3 additional complete chemistry panels, including the comprehensive metabolic panel, basic metabolic panel and electrolyte panel. The 4 analytes — Chloride (Cl-), Potassium (K+), Sodium (Na+), and Total Carbon Dioxide (tCO2) - were granted waived status by the FDA when used in conjunction with the Piccolo and Piccolo Xpress point-of-care analyzers for the medical market. Abaxis is a medical products company manufacturing point-of-care blood analysis systems.

• AngioDynamics (Queensbury, New York) reported results from a 10-year study showing actual 3-year and 5-year survival rates of 20.2% and 18.4%, respectively, in 234 patients that had undergone radio frequency ablation (RFA) of colorectal hepatic metastases. The patients in this study were not candidates for surgery and had failed chemotherapy prior to receiving RFA; in the absence of treatment, these patients have 5-year survival rates near zero. The paper’s key points include: in patients deemed unresectable in interdisciplinary review and pre-treated with chemotherapy, median survival after RFA is 24 months; for reference, median survival after failure of modern, first-line chemotherapy without subsequent RFA or surgery is 12 to 15 months; about 24% of patients who participated in the study had documented extra-hepatic disease, but this presence of extra-hepatic disease did not negatively impact survival; the mean size of the dominant lesion was 3.9 cm; lesions ranged in size from 1.1 cm to 10.2 cm. AngioDynamics makes medical devices used by interventional radiologists, surgeons, and other physicians for the minimally invasive treatment of cancer and peripheral vascular disease.

• C. R. Bard (Murray Hill, New Jersey) said that it has received clearance from the FDA to market its Agento IC silver-coated endotracheal tube. The clearance includes claims for the reduction of microbiologically confirmed ventilator associated pneumonia (VAP). Management is currently evaluating the benefits of launching the Agento IC product in conjunction with the potential publication of the clinical trial results in a major peer-review medical journal. C.R. Bard makes technologies in the fields of vascular, urology, oncology and surgical specialty products.

• Invitrogen (Carlsbad, California) and Biosynth (Staad, Switzerland) reported the launch of a novel, fluorescence-based culture medium for rapid detection of methicillin-resistant Staphylococcus aureus (MRSA) in hospitals and medical settings. The new BCM MRSA ELF culture media will be manufactured and sold by Biosynth under license from Invitrogen’s molecular probes business. BCM MRSA ELF is designed to provide faster test results for active surveillance culturing, the most widely used method in hospitals and clinics to monitor, manage and prevent transmission of MRSA. Invitrogen makes life science technologies for diagnostics. Biosynth makes specialty chemicals for life science and pharmaceuticals.

• KarmelSonix (Elsternwick, Australia) has received FDA approval for the WIM-PC. KarmelSonix specializes in the mathematical analysis of sounds emanating from the body, specifically wheezing heard in asthmatic patients. The device consists of a sensor attached to the patient’s neck and chest near the windpipe, and a computerized system that analyses the sounds and determines whether they indicate a life threatening situation requiring the sufferer to be admitted to hospital, or whether the condition can treated at home or at a clinic.

• Opus Healthcare Solutions (Austin, Texas) reported the debut of OpusMobility. The product enables physicians to continue monitoring their patient’s lab results and diagnostic reports outside of the hospital – at home, the office or on-the-road using WiFi or cell phone secure networks. OpusMobility operates on industry standard Microsoft PDA and smart phone devices. OpusMobility is one of the OpusClinicalSuite series of truly Web-based products which include systems for clinical documentation, order management, computerized physician order entry, medication administration, Web portals for remote physician access, and laboratory workflow. Opus healthcare makes clinical information systems.