BB&Ts

Traditionally when a patient experiences chest pain, a caregiver has to find and move an ECG machine from a different location to the patient's bedside. It's a practice that can cost caregivers and patients valuable time. And with electronic records coming to the forefront in many hospitals, a new need for hospitals is emerging, one that would call for devices to be made to link hospital networks, information systems and other types of digital information.

GE Healthcare (Waukesha, Wisconsin) is taking this need head on with the launch of its Carescape Monitor B850. The monitor was given FDA approval recently and provides caregivers with integration between patient monitoring data and hospital information systems.

The company touts that unlike traditional patient monitors, Carescape Monitor B850 directly links hospital networks, electronic medical records (EMRs), diagnostic images, lab results and third-party devices with real-time patient monitoring data, to support efficient clinical decision-making. This enables Carescape Monitor B850 to integrate its continuous clinical measurements with other elements of the patient record, delivering it at the point of care.

"The development of Carescape has a lot to do with what our customers are telling us, and that is that hospitals are becoming ICUs. Patients are becoming sicker and sicker," Dan Winger, Global Products Manager for GE Healthcare told BB&T. "The amount of info that needs to be in a clinicians hands at any given time is much greater than it's ever been before."

The Carescape manager brings together elements from Datex-Ohmeda and Marquette Electronics, two companies that GE Healthcare purchased.

"We basically acquired these two great companies, which had a few product lines in (development) and developed Carescape," Winger said.

The device takes elements of Datex-Ohmeda's expertise in anesthesia and Marquette Electronic's cardiac expertise.

The Carescape Monitor B850 enables bedside viewing of hospital EMRs, as well as x-rays, labs and other diagnostic reports, including the associated diagnoses from the hospital's experts. This quick, comprehensive view of the patient's records encourages confidence as clinicians make critical decisions at the point of care.

The device has actually already been installed in hospitals in Europe and Asia and has received CE mark approval.

The product will be tailored to the specific needs of various hospitals departments, such as the operating room and ICU, according to the company. Pricing depends on the different needs of each hospital. It will be compatible with existing GE products.

Elsehwere in the product pipeline:

• Aperio Technologies (Vista, California) has launched a service that it says delivers a comprehensive digital pathology solution capable of achieving a guaranteed slide throughput, i.e., the ability to digitize a pre-determined number of glass slides per hour. The Clinical Partner Service (CPS) program is designed specifically for hospitals and reference labs that need to scan batches of slides in a limited period of time on a daily basis. The CPS program enables labs to adopt digital pathology without the need for investing up-front capital.

• BD Diagnostics - Preanalytical Systems, a unit of BD (Becton, Dickinson; Franklin Lakes, New Jersey), has received FDA clearance for the BD Vacutainer Rapid Serum Tube, a blood collection device designed to help acute healthcare facilities rapidly analyze blood serum for patient diagnosis. BD says the Vacutainer Rapid Serum Tube is the first serum blood collection tube with a gel additive to be launched in the U.S. that can be centrifuged only five minutes after the tube is filled. Standard serum tubes require a 30-minute clot time prior to centrifugation. This reduction in clot time significantly shortens sample processing time and the time it takes for clinical laboratory professionals to begin analyzing and getting test results.

• BioImagene (Sunnvale, California) reported the availability of the next generation of its digital pathology solution, Virtuoso. A highlight in this version is the ability to share cases in real time, allowing pathologists to collaborate with each other to sign out cases. Virtuoso users can participate in peer reviews, perform second-opinions for difficult cases, and guide residents in the review of cases for education. The new Virtuoso release includes new algorithms. BioImagene says it now offers more than 100 algorithms which include IHC algorithms such as HER2, ER/PR and p53 for breast cancer, Ki67 for breast, brain and prostate cancers, CD138 for multiple myeloma and CD3/CD20 for lymphoma. These specialized algorithms aid pathologists in the quantitative assessment of biomarkers that in many cases help determine patient suitability for specific cancer therapies.

• FlowCardia (Sunnyvale, California) has launched the FlowMate Injector, which it claims dramatically simplifies central lumen crossing of chronic total occlusions (CTOs) using the Crosser CTO Recanalization Catheter. The company says the FlowMate provides unparalleled convenience by granting full control of the procedure to a physician via a single foot pedal, which initiates FlowMate's precise saline delivery as well as the generator which activates the Crosser Catheter.

• Gauthier Biomedical (Grafton, Wisconsin) reported the availability of a new line of specialized surgical instruments with its Twist-N-Load Connection System. The company said that with the Twist-N-Load, users don't have to pull back on any collar, or push a button to begin the connection process. With a simple twist of the wrist, the shaft quickly locks into place providing an instrument with extreme integrity and zero play. According to Gauthier, the system is perfect for users who require multiple connection changes, or simply want the convenience of an almost immediate, quick and sturdy connection.

• Given Imaging (Yoqneam, Israel) said the FDA recently cleared its PillCam SB video capsules and Agile patency capsules for use in patients two years of age and older. Previously PillCam SB and Agile were indicated for children 10 years and older. PillCam SB is cleared for the visualization of the small bowel mucosa and may be used as a tool for the detection of abnormalities of the small bowel. PillCam capsule endoscopes are ingestible video capsules that enable physicians to visualize distinct portions of the GI tract. Patient friendly in nature, PillCam endoscopy typically is used on an outpatient basis and has been clinically validated, as evidenced by more than 1,000 peer-reviewed publications.

• HeartWare International (Framingham, Massachusetts) has received FDA approval to expand the number of clinical sites participating in its U.S. bridge-to-transplant trial, known as the ADVANCE trial. HeartWare will be permitted to enroll a total of 40 clinical sites for the purposes of evaluating the Company's Ventricular Assist System (HVAD) in end-stage heart failure patients requiring circulatory support to bridge them to a heart transplant. The HeartWare Ventricular Assist System features the HVAD pump, a small full-output circulatory support device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices.

• Iridex (Mountain View, California) reported the introduction of FlexFiber - a laser fiber probe intended for effective delivery of laser energy during ear, nose and throat (ENT) procedures. FlexFiber is intended for the delivery of laser energy during ENT procedures. It is indicated for, but not limited to, incision, excision, coagulation, and vaporization of soft and fibrous tissue, including osseous tissue.

• IVAX Diagnostics (Miami) said that its U.S. subsidiary, Diamedix, has filed a 510(k) premarket submission with the FDAfor its next -generation fully automated Enzyme-linked Immunosorbent Assay (ELISA) system for autoimmune and infectious disease testing, named the Mago 4S. IVAX Diagnostics believes the new instrumentation will provide a flexible, efficient and cost-effective solution to today's high-performance laboratory demands.

• Life Spine (Hoffman Estates, Illinois) received FDA marketing approval to the Sentinel Occipito-Cervico-Thoracic (OCT) System. The Sentinel OCT System provides rigid stabilization and promotes fusion from the occiput to thoracic spine, and features streamlined implants and instruments to address complicated procedures. Polyaxial screws are available in multiple diameters and lengths, and offer a generous cone angulation, which simplifies alignment with the rod and minimizes rod contouring. The addition of the Sentinel OCT System to the current broad product offering is a watershed event providing the ability to offer surgeons a full range of solutions to address spinal pathologies from the occiput to the sacrum.

• KarmelSonix (Haifa, Israel) has received FDA clearance for the WheezoMeter, a diagnostic tool that measures a patient's wheezing before and after tests with a bronchodilator, thereby demonstrating the effectiveness of asthma treatments. The WheezoMeter analyzes 30 seconds of breath sounds using advanced signal processing algorithms to detect, quantify and objectively document the presence of wheeze and its extent, the WheezeRATE. The WheezoMeter is calibrated and validated as determined by consensus of a panel of experts who evaluated and scored many recordings for presence of wheeze. The WheezoMeter uses a cascade of 6 proprietary technologies to "defend" the signals against false detection of ambient noises as wheeze.

• Lumenis (Santa Clara, California) reported the launch of the AcuPulse Fractional CO2 Laser System for aesthetic applications. "The AcuPulse now gives physicians an affordable and efficient solution to their Pulsed Fractional Skin Resurfacing needs," said Robert Mann, GM of Lumenis. "It has been well established that pulsed CO2 lasers are superior in the treatment of wrinkles, skin dyschromias, certain types of scars, and the Lumenis' AcuPulse brings its SuperPulse technology with the unmatched fractional scanning excellence of the Lumenis portfolio to give physicians an excellent solution for their practice."

• Positron (Fishers, Indiana) has reported sales of the Tech-Assist to a number of top institutes in the U.S. The Tech-Assist is a portable dose administration system used during Fluorodeoxyglucose F-18 (FDG) injections for Positron Emission Tomography (PET) studies. The Tech-Assist provides tungsten shielding, increased distance and reduction of time spent in proximity to the radioactive source during transport and the injection process.

• ProUroCare Medical (Minneapolis) reported the completion of a National Institute of Health and National Cancer Institute-supported clinical study. The study's purpose was to evaluate the ability of the company's ProUroScan imaging system to visualize and document abnormalities in the prostate detected or monitored by the digital rectal exam (DRE). The results of the clinical study will be submitted to the FDA in support of a 510(k) application in the near future after third party validation of the data. The ProUroScan imaging system is designed to complement the DRE, and to provide patients with potential prostate abnormalities the ability to have their prostates imaged in real time with records electronically stored for later comparison.

• Response Genetics (Los Angeles) reported the availability of its ResponseDX: Gastric genetic test panel, a PCR-based diagnostic test. By analyzing the expression of genes that correlate with response to commonly used chemotherapy agents, physicians can better tailor treatment for their patients with gastric cancer and gastroesophageal (GE) junction cancer. Response estimates that almost 37,000 people diagnosed with cancer each year in the U.S. may benefit from ResponseDX: Gastric testing. The ResponseDX panels include four key genes: excision repair cross-complementing factor 1 (ERCC1), thymidylate synthase (TS), human epidermal growth factor receptor 2 (HER2) and epidermal growth factor receptor expression (EGFR). These test panels also include the analysis of EGFR gene mutations in NSCLC and K-ras (KRAS) gene mutations in colorectal cancer. Using ResponseDX testing, clinicians may make better treatment decisions by adopting a cost-effective panel approach.

• Signostics (Palo Alto, California) reported the launch of its new palm-sized, affordable ultrasound product for point-of-care use by medical practitioners. Signostics says the product is equivalent to the size of a smart phone. This allows physicians to place the device in their pocket or wear around their neck like a stethoscope until the next use, increasing the convenience of using ultrasound for diagnosis at the point of care. The product allows for volume measurements, customized patient data, voice note recording and multiple transducer frequencies, and is intended for use in a wide range of applications, including: abdominal assessments such as bladder, abdominal aortic aneurysm screening, and trauma assessment; musculoskeletal; and basic obstetrics, such as pregnancy viability and fetal positioning.

• Spectranetics (Colorado Springs, Colorado) said that it has filed a 510(k) application with the FDA seeking clearance for the treatment of in-stent restenosis (ISR) in the legs with its peripheral atherectomy products. ISR is caused by the re-growth of tissue within the stent, known as neointimal hyperplasia, which can lead to blockages in the affected leg artery. The 510(k) application makes reference to the results of bench testing associated with the interaction of laser and nitinol stents. These testing shows that stents subjected to extensive fatigue testing following laser interaction had no fatigue-related failures. The company's Vascular Intervention (VI) products include a range of peripheral and cardiac laser catheters for ablation of occluded arteries above and below the knee and within coronary arteries.

• Quantros (San Francisco) reported significant updates to its Regulatory Reporting Management (RRM) hospital performance improvement solution to coincide with National Hospital Quality Measures (NHQM) updates for October 2009 discharges. Quantros RRM will now include expanded tracking of venous thromboembolism and emergency department measures endorsed by The Joint Commission. Surgical Care Improvement Project quality indicators, including Inf-9 for postoperative urinary catheter removal and Inf-10 for perioperative temperature management, will also be incorporated within the Quantros RRM solution suite.

• T-System (Dallas) said that its latest content update for its T SystemEV electronic Emergency Department Information System (EDIS) incorporates the latest Centers for Disease Control (CDC) information to facilitate the diagnosis and treatment of H1N1, as well as the seasonal flu, for both adult and pediatric cases. The company says the new content updates for T SystemEV will assist healthcare providers in the evaluation, diagnosis and treatment of patients presenting with potential H1N1 influenza symptoms, as well as seasonal flu. The update to content version 906 of the T SystemEV will include both modified upper respiratory templates for physicians and nurses that will make it easier to document flu cases and flu exposure, as well as new influenza-specific templates for doctors and nurses for both adult and pediatric flu cases.

• Trophos (Marseille, France) reported the launch of the new generation of its fluorescence fast plate imaging system; the Plate Runner HD. Trophos originally developed the Plate Runner HD to speed up its own screening campaigns for drug discovery and development. The Plate Runner HD is a rapid fluorescence 96-plate imager giving full 7 mm well images in single snapshots (ie no mosaic reconstruction), embedding three commonly used wavelength illumination lamps using fast-switching LED technology, thus leading to more homogeneous light, very long life time (100 000 hours against 5000 hours for xenon or mercury lamps), higher speed and dramatically reduced maintenance costs. Images are given in standard 1024 x 1024 definition but also in higher 2048 x 2048, 4096 x 4096 and even 8192 x 8192 pixels definition, leading to details of about 1 micron in size.

• US Spine (Boca Raton, Florida) reported the launch of the Phantom Plus Interbody Fusion System. Phantom Plus provides spine surgeons with next generation instrumentation and implants that offer a compliment to US Spine's posterior fixation systems. Features include tapered leading edges for easy insertion, a higher degree of doming to more closely match endplate anatomy, anti-migration teeth, and advanced instrumentation for multiple insertion techniques. The implants are made from Peek-Optima Polymer from Invibio, and are available in several geometries to accommodate the various approaches to the spinal disc space.

• Verathon (Bothell, Washington) has introduced the AortaScan AMI 9700 aortic measurement instrument to help physicians identify the presence of abdominal aortic aneurysms (AAA). The portable AortaScan AMI 9700 uses 3D ultrasound to quickly and noninvasively measure the diameter of the abdominal aorta, without the need for a sonographer. This crucial diameter measurement helps physicians identify the presence of AAA. When the scan button is pressed on the AortaScan AMI 9700, the instrument measures ultrasonic reflections on multiple planes inside the body and produces a three dimensional image. Based on this image, the AMI 9700 calculates and displays the diameter of the abdominal aorta on the color console, and offers

• Z-Medica (San Diego) reported that data from a recent study of QuikClot hemostatic gauze demonstrated QuikClot to be a safe and effective way to achieve hemostasis in pediatric patients undergoing adenotonsillectomy. The purpose of the study was to evaluate the safety and efficacy of QuikClot kaolin-based hemostatic dressings in 123 pediatric patients undergoing adenotonsillectomy. The study found that the use of the hemostatic gauze resulted in excellent outcomes. With the application of QuikClot hemostatic gauze, the average time to bleeding control was 108+/-61 seconds and complete hemostasis was achieved within five minutes in 83% of the cases.