• Celerus Diagnostics (Denver) reported the launch of a new system, the Wave, at the U.S. and Canada Academy of Pathology (USCAP; Augusta, Georgia) meeting. Capable of producing immunohistochemistry (IHC) results in 15 minutes, the company said that the Wave accelerates lab throughput, enabling intra-operative testing, and providing real-time pathology to requesting physicians. By repeatedly opening and closing slide segments, “Dynamic Replenishment Technology” creates kinetic “waves” which mixes and refreshes reagents. This recharging process continuously floods antigenic sites on the tissue with new waves of primary and secondary reagents, providing more efficient biding, accelerating reaction times, and enabling 15-minute IHC turnaround times. Celerus develops cancer diagnostics.

• Covidien (St. Louis) said the FDA has granted tentative approval for the company’s abbreviated new drug application (ANDA) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection. Covidien’s tentatively approved product is a generic of Cardiolite, which is a myocardial perfusion imaging agent used for detecting coronary artery disease.

• Falcon Electric (Irwindale, California) introduced the new FH Series Biomedical & Laboratory-Grade uninterruptible power systems (UPS), specifically designed for the power requirements of biomedical and laboratory equipment. Designed to protect valuable tests and scientific processes, the FH Series 3 to 10kVA UPS assure a high level of power required by analyzers, sequencers, diagnostic equipment and gas chromatography/mass spectrometer instrumentation, as well as other testing and computerized processing equipment. The company says the FH Series’ on-line design provides “clean, tightly regulated power” that assures the highest level of protection for a wide spectrum of scientific equipment – from forensics and hospital biomedical labs to semiconductor production, robotics and uranium fuel processing.

• Hologic (Bedford, Massachusetts) reported the publication of a study evaluating the Hologic MammoSite radiation therapy system (RTS), one, two and three years after treatment. The authors note that the RTS is “logistically simpler, technically more reproducible, and patient ‘friendly’” than other interstitial brachytherapy devices. The MammoSite device is a balloon catheter that is inserted into the cavity created by a lumpectomy (the surgical removal of a breast tumor). MammoSite RTS delivers radiation from inside the lumpectomy cavity over a course of five days. The device targets radiation to the area where tumors are most likely to recur, while reducing exposure to healthy tissue. Hologic specializes in imaging systems, diagnostics and interventional devices for women.

• iCAD (Nashua, New Hampshire) reported the availability of the TotalLook MammoAdvantage system which converts prior mammography films to digital images for comparative review on a single digital review workstation. This new version of iCAD’s state-of-the-art film digitizing solution offers improved image quality, enhanced image customization options and workflow efficiency features. TotalLook MammoAdvantage’s new DigitalLook and PremiumLook image outputs closely match digital mammography images offering enhanced tissue visualization, higher contrast and better edge definition to improve comparative reading. TotalLook MammoAdvantage’s unique software offers configurable image resolution settings that display the digitized images at the same resolution as the digital mammography images, enabling the digitized and newly acquired digital images to be displayed at the same size. The software provides flexible DICOM connectivity solutions for seamless integration with leading review workstations, PACS and RIS systems. iCAD makes Computer-Aided Detection (CAD) solutions for the early detection of cancer.

• Immunicon (Huntingdon Valley, Pennsylvania) said the FDA has cleared the CellSearch Circulating Tumor Cell (CTC) Kit as an aid in the monitoring of patients with metastatic prostate cancer. A sample of the patient’s blood is processed with the CellSearch Kit using the CellTracks System to capture and count CTCs. This clearance represents another expansion to claims for the kit, which is now cleared for three of the four most prevalent cancers. According to the American Cancer Society, prostate cancer claims approximately 27,000 lives each year, the vast majority of which are a result of recurrent metastatic disease. Metastatic prostate cancer occurs when tumor cells spread to other locations in the body and grow. Immunicon makes cell- and molecular-based human diagnostic and life science research products with an initial focus on cancer disease management.

• Iris International (Chatsworth, California) said that its Iris Molecular Diagnostics (IMD) group has completed a retrospective study of stored leftover serum of 85 post-prostatectomy patients, men who had their prostate removed due to prostate cancer, using its investigational NADiA (Nucleic Acid Detection ImmunoAssay) PSA Assay. In this study, the NADiA PSA Assay detected levels and increasing levels of PSA that were previously undetectable using conventional ultra sensitive assays, thus potentially enabling the detection of biochemical recurrence (BCR) an average 2-1/2 years earlier than with the most sensitive commercially available tPSA assays. Iris International makes medical devices, diagnostic systems and consumables.

• Masimo (Irvine, California) said that it will debut its technology for noninvasive and continuous total hemoglobin (SpHb) and oxygen content (SpOC) monitoring. Masimo said that this SET technology platform will provide clinicians with access to real-time trending and tracking of a patient’s total hemoglobin status enabling them to quickly identify conditions of anemia, or blood loss. When patients undergo blood transfusions, clinicians will be able to use Masimo Rainbow SET SpHb to titrate blood and maintain hemoglobin levels within acceptable ranges. Because blood and hemoglobin restoration must be carefully titrated to targeted levels to avoid potentially serious morbidities, Masimo Rainbow SET SpHb provides instant feedback that the proper levels are achieved, advancing patient safety and accelerating recovery. An upgrade to most Masimo Radical pulse oximeters is all that will be necessary to transform an existing monitor to Masimo Rainbow SET performance. Masimo is the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low Perfusion pulse oximetry products.

• Nutra Pharma (Boca Raton, Florida) said that its wholly-owned medical devices subsidiary, Designer Diagnostics, has started marketing what it said is the first-ever environmental test kit for the detection of nontuberculous mycobacteria (NTM) in water and soil. NTM, also known as atypical tuberculosis (Atypical TB) or mycobacterium other than tuberculosis (MOTT), is a bacteria that is found in a multitude of environments — in the soil, in some domestic and wild animals, and perhaps most importantly, in water, including showers and hot tubs. One of the most common forms of NTM infections found in humans is Mycobacterium avium complex (MAC). This is a primary cause of respiratory disease in humans and is a leading cause of death in HIV/AIDS patients. Nutra Pharma is a biotechnology company that is developing drugs for HIV and multiple sclerosis

• QuantRx Biomedical (Doylestown, Pennsylvania) said that David Elmaleh, chairman and chief scientific founder of FluoroPharma, will present findings from the company’s Phase I trial for CardioPET, a metabolic cardiac imaging agent for the assessment of coronary artery disease. The trial was a single-center, open-label study, designed to evaluate safety, dosimetry, and pharmacokinetics of CardioPET as a PET tracer for myocardial imaging. Fifteen normal healthy volunteers and six CAD patients participated in the Phase I trial. FluoroPharma is a molecular imaging company engaged in the discovery and development of products for the PET market. QuantRx Biomedical is a diagnostics company

• SonoSite (Bothell, Washington) reported the introduction of the new M-OB/GYN Office ultrasound tool for the physician’s office. Based on SonoSite’s fourth generation M-Turbo platform, the M-OB/GYN Office system delivers an exponential increase in processing power and superior image clarity for obstetrical and gynecological imaging, plus connectivity for digital image export in a rugged, easy to use form factor. Each M-OB/GYN office tool comes complete with two transducers - the C60x/5-2 MHz curved array transducer for abdominal scanning and the ICTx/8-5 MHz intracavitary curved array transducer for pelvic imaging. A specialized software package includes Tissue Harmonic Imaging, color Doppler and advanced OB calculations. SonoSite also introduced the S-MSK ultrasound tool, which it said is the first ultrasound product customized for musculoskeletal specialists – including rheumatologists, physiatrists, sports physicians, orthopedic and osteopathic surgeons and physical therapists. Configured for use with SonoSite’s HFL38x and L25x broadband transducers, the S-MSK provides imaging of superficial and deep targets for a quick look assessment and guidance of interventional procedures such as injections and aspirations of the knee, shoulder, elbow and other joints in the body. SonoSite makes hand-carried ultrasound.