Pulmonologists at Presbyterian Hospital (Dallas) have begun using a new type of bronchoscopy that uses GPS-like technology to generate 3-D images of the far reaches of complex lung structures. This electromagnetic navigational bronchoscopy is expected to help pulmonologists better diagnose lung cancer, pneumonia and various pulmonary infections.
"This new technology allows us to see safely and clearly into those deep regions of the lungs and diagnose exactly what's causing the respiratory problem," said Presbyterian pulmonologist Suneel Kumar, MD.
The inReach system from privately-held superDimension (Minneapolis) was cleared for marketing in the U.S. in September 2007. According to the company, the new imaging tool helps doctors reach smaller, harder-to-reach lung lesions.
Presbyterian has been using the new device since January, Kumar told Biomedical Business & Technology. He says the device is unlike anything else on the market that he is aware of.
"The big benefit is that we can certainly go after lesions that are smaller and even go after them more accurately by being able to plan out the procedure beforehand using the patient's CT scan," Kumar said.
Until now, most lesions beyond the reach of a standard bronchoscopy were further investigated with more invasive procedures that had side effects some patients could not tolerate, according to Presbyterian.
"This new technology allows us to more aggressively investigate the origin of disease in the lungs with less impact on the patient," said pulmonologist Howard Mintz, MD. "We're able to more accurately diagnose the condition of the lung and, in turn, better care for the patient."
superDimension says the inReach system provides a 3-D virtual "roadmap" of the lungs that enables a physician to maneuver the inReach catheters through multiple branches of the bronchial tree to reach targeted lesions. The new system uses a steerable catheter that also can access and biopsy lymph nodes that are near the bronchial tree or trachea.
According to the company, after a patient's CT scan of the lungs is imported into the inReach planning laptop, a three-phase process occurs: planning, registration and navigation.
"There's a big need for a reliable diagnostic tool that's minimally invasive for patients but still provides quality analysis of tissue deep in the lungs," Kumar said. "This system is a major step in that direction."
Elsewhere in the product pipeline:
• Aethlon Medical (San Diego) said it has added a second HIV/AIDS clinical study location at the Bhvani Hospital (Bihar, India). Aethlon previously disclosed plans to initiate its "first-in-man" clinical study of a medical device to treat HIV. The Aethlon Hemopurifier is a medical device created to provide real-time therapeutic filtration of infectious viruses and immunosuppressive proteins. The Hemopurifier provides real-time therapeutic filtration of infectious viruses and immunosuppressive particles, and is positioned to address the treatment of drug and vaccine resistant viruses. Additionally, the device holds promise in cancer care, as research studies have verified the Hemopurifier is able to capture immunosuppressive particles secreted by tumors. The Hemopurifier holds promise to extend the lives of AIDS patients by removing HIV strains that cause drug failure and reducing the presence of viral proteins that kill-off immune cells. Aethlon Medical makes the Hemopurifier, a medical device designed to treat infectious disease.
• AngioScore (Fremont, California) reported the launch of new longer and larger AngioSculpt PTA scoring balloon catheters for the treatment of peripheral artery disease (PAD). The new devices have received FDA clearance to market for the dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The PTA catheter is not labeled for use in the coronary or neuro-vasculature. The new AngioSculpt devices incorporate longer (40 mm) balloons and scoring elements in the larger- diameter (4.0 mm and 5.0 mm) balloons. These new sizes are expected to be particularly useful in treating long and diffuse lesions typically encountered in the treatment of complex PAD. AngioScore makes angioplasty catheters for use in the treatment of cardiovascular disease.
• AirStrip Technologies (San Antonio) said it is in the advanced stages of development for its AirStrip OB medical application for the new Apple iPhone 3G. AirStrip OB, which is already available for use on PDAs and Smartphones, will allow obstetricians to use their iPhones to remotely access virtual real-time and historical waveform data for both the mother and baby directly from the hospital's labor and delivery unit using only a cell phone connection.
• Arkray USA (Minneapolis) reported FDA clearance for the Glucocard 01 blood glucose monitoring system. The Glucocard requires no coding, displays results in 7 seconds, and requires a 0.3 microliter sample size. Glucocard 01 is AST approved and has a 360-count test memory with time and date stamp.
• ATS Medical (Minneapolis) said it has obtained new in vivo data to support the wear characteristics of the ATS Open Pivot Mechanical Heart Valve. The first ATS Open Pivot valve was implanted in Lausanne, Switzerland, in May 1992. The patient was 70 at the time of his surgery and enjoyed another active 15 years with his ATS Open Pivot valve. He recently died of non-valve-related causes and his physician and family permitted the explantation of his Open Pivot valve for scientific analysis. Scanning electronic microscopy and laser profilometry were used to quantify the wear on the carbon portion of the valve. After 15 years of use and an estimated 560 million opening and closing cycles, the Open Pivot valve displayed no detectable wear.
• Aureon Laboratories (Yonkers, New York) has introduced Prostate Px+, a test that predicts prostate cancer progression and disease recurrence at the time of diagnosis. "Prostate Px+ is the first prognostic test to provide this critical information at diagnosis. This technology represents a new integrated approach known as systems pathology that combines molecular biomarkers, histological and clinical information with advanced mathematics," said Ricardo Mesa-Tejada, MD, VP of pathology and medical director of Aureon Laboratories. "At the time a man is diagnosed, Prostate Px+ will forecast disease progression after treatment, detect high-risk patients presenting as low risk and undetectable by other methods, reclassify intermediate-risk patients and help identify those with less aggressive disease.
• Axway's (Scottsdale, Arizona) Synchrony Healthcare Compliance Suite is now available as a Software-as-a-Service (SaaS) solution, giving companies the only all-in-one platform solution that can improve supply chain agility, efficiency and cost-effectiveness without making a significant investment in IT infrastructure. Synchrony Healthcare Compliance Suite On Demand fits Axway's "start anywhere, use anything" architecture, allowing companies to use one or more of the applications as needed to meet their business requirements. The Suite helps the pharmaceutical supply chain significantly increase the availability of information, ensure compliance, gain insight into the performances of the supply chain and reduce operations expenses. Companies using the Healthcare Compliance Suite are able to improve operational efficiency through supply chain visibility, enable product authentication and assure data integrity across all supply chain transactions.
• Biolase Technology (Irvine, California) reported the launch of its new Waterlase C100 hard- and soft-tissue laser. Designed for the restorative general dentist, the Waterlase C100 provides clinical procedures including cavity preparation, early stage periodontal therapy and soft tissue procedures with more patient comfort compared to conventional instrumentation. The Waterlase C100 all-tissue laser combines Waterlase YSGG technology with reliability, clinician control, operating efficiency, and flexibility in tip and accessory selection. While it offers a narrower scope of applications than Waterlase MD, it provides for an advanced level of clinical results and patient comfort in a wide range of hard- and soft-tissue procedures.
• Biotronik (Lake Oswego, Oregon) reported the release of the Stratos LV cardiac resynchronization therapy pacemaker (CRT-P). Stratos LV is a CRT pacemaker a device which provides low-voltage stimulation for resynchronization therapy, but not defibrillation. CRT devices are indicated for certain types of heart failure patients and may improve the pumping action of the heart by helping to synchronize the heart's lower chambers (the ventricles). Stratos LV offers a feature to help assure that resynchronization therapy is delivered continuously with RVsense Triggering. RVsense Triggering helps maintain resynchronization by forcing the pacemaker to pace the left ventricle whenever there is activity in the right ventricle (whether it is a paced event or the heart beats on its own). This assures that there will be no "one-sided" cardiac activity, and may help to preserve ventricular ejection fraction (a standard measure of the heart's ability to pump blood efficiently), reduce symptoms of heart failure, and synchronize ventricular intrinsic contraction within 2.5 ms of a sensed or paced event in the right ventricle.
• CardioTech International (Wilmington, Massachusetts) said that it has received FDA approval to export its 4 mm graft in further support of the ongoing European clinical trial of CardioPass, the company's synthetic coronary bypass graft. CardioPass is designed to be an alternative for patients who have undergone repeat procedures or have insufficient native vessels for bypass. Repeat surgeries account for up to 20% of all bypass procedures. CardioPass is made from ChronoFlex, the company's biodurable medical-grade polymer and engineered to be pulsatile, biostable, torque-resistant and suturable. Once it is implanted, the graft's polymer construction allows it to incorporate the patient's own cells and tissue, so that the inner surface mimics the normal environment for blood contact.
• CBaySystems (Annapolis, Maryland) reported the launch of Kyps, the brand name for CBaySystems' web-based practice management and electronic medical record (EMR) system targeted at small- and medium-sized physician practices in the U.S. Kyps combines a practice management system, an electronic medical record solution and a medical transcription service into a single, integrated web-based program offered as a "pay as you go" service. The Kyps service allows physician practices to avoid the upfront capital and ongoing hardware and software costs of traditional practice management and EMR solutions.
• Clarient (Aliso Viejo, California) reported its new offering, KRAS, which has been validated as a laboratory-developed test to be used as a predictive molecular biomarker for patients with colorectal cancer (CRC). In colorectal cancers, EGF-receptors transmit a series of signals through a complex path of intracellular proteins. These signals ultimately instruct the cancer cell to undergo a transcription process leading to cancer progression. Anti-EGF-receptor therapies such as panitumumab (Vectibix from Amgen) and cetuximab (Erbitux from ImClone Systems) work by blocking the activation of EGF-receptor. By blocking activation of the receptor, these drugs are successful in inhibiting downstream events that lead to malignant signaling. KRAS is located downstream of EGF-receptor and is a vital component in orchestrating this signaling process.
• Core Essence Orthopaedics (Yardley, Pennsylvania) has introduced a line of surgical solutions focusing on soft tissue and skeletal repair of the extremities. The products include the Securus Knotless Suture Anchor System, initially targeted at arthroscopic rotator cuff repair. Other key products are the nABLE Percutaneous Suture Management System, PONTiS Endotendonous Repair System, reVERTO Shape Memory Staples, SEGWAY Synchronized Endoscopic Guide System, and the reNOVO Suture Anchor System.
• Covidien (St. Louis) said that its imaging solutions business is launching the Optistar Elite contrast delivery system. The product is designed to inject contrast media-related drugs into a patient's vascular system to aid in obtaining diagnostic images when used with magnetic resonance (MR) imaging equipment. One of the features on the Optistar Elite injector is Patency Check, which aids in preventing extravasation, assists in reducing the potential of certain medical errors and helps enhance clinical and work flow efficiency. The Optistar Elite, combined with the use of Covidien's Ultraject prefilled syringes for contrast media-related drugs, can help decrease the risk of certain medication errors that may be caused by manually filling syringes.
• CryoLife (Kennesaw, Georgia) reported that positive mid-term performance data on the CryoValve SG decellularized pulmonary human heart valve were presented at the Western Thoracic Surgical Association meeting in Kona, Hawaii. The results showed that there was a statistically significant reduction in structural valve deterioration in patients who received the CryoValve SG for right ventricular outflow tract reconstruction procedures (RVOT) as compared to the conventionally processed valve. Valvular insufficiency occurs when the valve leaflets do not completely seal when the valve is closed, causing regurgitation, or the backward flow of blood into the heart chamber. The CryoValve SG pulmonary human heart valve is indicated for the replacement of diseased, damaged, malformed or malfunctioning native pulmonary valves. The valve can be used in conjunction with RVOT, commonly performed in children with congenital heart defects.
• Dale Medical Products (Plainville, Massachusetts) has introduced a bariatric abdominal binder which includes a Velcro strip that can be placed anywhere to secure drainage bulbs and tubing, without pins or tape. The Dale Bariatric Abdominal Binder is an all-elastic, latex-free post-op support that features paneled construction to prevent riding, roping, and folding over. Evenly distributing compression to brace abdominal muscles, the binder includes an EasyGrip Strip which can be placed anywhere on the binder to secure drainage bulbs and tubing without pins or tape. The Dale Bariatric Abdominal Binder can be cut to create a hole for the drainage tube prior to positioning the EasyGrip Strip for holding up to four drainage bulbs. The device is available in 11 sizes.
• Derma Sciences (Princeton, New Jersey) said it has launched its Medihoney dressing line by securing reimbursement codes for the three recently released new product formulations. The Statistical Analysis Durable Medical Equipment Regional Carrier (SADMERC) a contracted intermediary and carrier for the Centers for Medicare & Medicaid Services has notified the company of its decision regarding HCPCS codes for billing purposes for the Medihoney formulations. The new codes will allow applicable customers to bill for all the new Medihoney dressing formulations. Customers will include Medicare's Part B program, private insurance plans, and the various Medicaid programs.
• eCardio Diagnostics (The Woodlands, Texas) reported the launch of an extended monitoring device, the eTriggerPLUS, in conjunction with an extended monitoring service (EMS). Extended monitoring devices provide real-time data analysis allowing physicians to capture daily ECG information through pre-defined and programmable intervals. The eTriggerPLUS is the first generation of extended monitoring devices offered by eCardio. The single component device contains features such as the eTimer automatic data capture which expands the flexibility of the eTriggerPLUS for use in various patient therapies or clinical study applications such as: device monitoring, post-ablation follow-up, drug titration, and the documentation of abnormal cardiac function.
• Echo Therapeutics (Franklin, Massachusetts) said it has initiated a clinical study of its Symphony Transdermal Continuous Glucose Monitoring system (tCGM system) in patients with Type 1 and Type 2 diabetes. Echo's non-invasive Symphony tCGM system consists of its Prelude SkinPrep system, which incorporates patented and leading-edge skin permeation control technology, and wireless transmission and proprietary transdermal biosensor technologies. Echo's symphony tCGM system is designed to provide both diabetes and hospital patients with a continuous glucose monitoring device.
• EnteroMedics (St. Paul, Minnesota) said a new implantable medical device, developed in collaboration with Mayo Clinic (Rochester, Minnesota) researchers, shows promise as a reversible and less-extreme alternative to existing bariatric surgeries, according to findings published in the current issue of Surgery. In the company-funded trial, the 31 obese participants who received the vagal nerve blocking device, also called VBLOC vagal blocking therapy, lost an average of nearly 15% of their excess weight. A quarter of the participants lost more than 25%, and three patients lost more than 30%. VBLOC therapy is similar to a heart pacemaker, but instead of stimulating a normal, regular heartbeat, it uses high-frequency electricity to block the nerve impulses between the brain and the stomach and pancreas. A pacemaker continuously monitors the heart and regulates its beating. But the patient flips a switch to activate the VBLOC device when the system is worn during the daytime hours so that the blocking signal can influence how the stomach functions and food is digested following a meal.
• Gambro BCT (Lakewood, Colorado) said that it received FDA clearance for the commercial sale of Atreus Whole Blood Processing system in the U.S. The Atreus device automates the manufacturing process of a unit of whole blood. Replacing balances, centrifuges, expressers, sealers, and scales, the Atreus system reduces variability from the manufacturing process. In the future, the company also will distribute specialized tubing kits, including a single collect bag and a compatible processing kit. The initial offering allows blood centers to leukoreduce the Red Blood Cell unit by gravity filtration after processing. Gambro BCT, soon to be known as CaridianBCT, provides technology, products and services in automated blood collections, therapeutic systems, whole blood processes and pathogen reduction technologies.
• Inion (Tampere, Finland) said that it has received FDA clearance for its biodegradable graft containment systems for spinal fusion procedures. The clearance has been received for the Inion S-1 anterior cervical fusion system, the Inion S-1 double-level plate and the Inion S-2 anterior thoraco-lumbar fusion system. These systems consist of biodegradable plates and screws, which are designed for bone graft containment in spinal fusion procedures. Such procedures are carried out as a treatment for a range of spinal conditions including ruptures and displacement of inter-vertebral discs. Inion's S-1 and Inion S-2 graft containment systems include implants intended for use along the entire length of the spine in conjunction with traditional rigid fixation.
• InTouch Technologies, dba InTouch Health (Santa Barbara, California) reported the launch of a new product feature, StrokeRespond, to extend the functionality of its Remote Presence robotic technology for stroke experts. Remote Presence (RP-7) systems have already been deployed in stroke networks around the country, with results including improved geographical reach of stroke specialists and more timely delivery of appropriate stroke care. StrokeRespond is an enhancement to the Remote Presence platform and has been designed specifically to support the expert physician's acute stroke management workflow. Remote Presence is a telemedicine technology platform which combines the power of robotics, wireless, and the Internet to enable hospitals and physicians to bring the right care to a patient at the right time.
• Lutronic (Princeton Junction, New Jersey) said that it has received regulatory clearance from the FDA for the eCO2 system. Using the controlled chaos technology, this next-generation fractional CO2 laser is designed to offer ways to treat deep ablative indications such as resurfacing and coagulation of soft tissue, textural irregularities, fine lines, pigmented lesions, vascular dyschromia and rhytides. Of note is the ability to combine two operational modes in one delivery system, which is important when deep penetration and greater patient comfort is required. With both static and dynamic operation modes, users have the capability to stamp up to a 14 mm x 14 mm scan area as well as the option to "feather" the treatment area to reduce the "checkerboard" appearance that is common with currently available fractional CO2 devices.
• Masimo (Irvine, California) said that a new clinical study, published in the June issue of the British Journal of Anaesthesia, concluded that under the study protocol Masimo's PVI measurement "can predict fluid responsiveness in mechanically-ventilated patients under general anesthesia." PVI is a new measurement available in the Masimo Rainbow SET technology platform that allows noninvasive, automated, and continuous monitoring of the variation in the pulse oximeter waveform amplitude during respiration. Masimo Rainbow SET continuously and noninvasively measures total hemoglobin, oxygen content, carboxyhemoglobin, methemoglobin, and PVI, in addition to oxyhemoglobin, pulse rate, and perfusion index, allowing early detection and treatment of potentially life- threatening conditions.
• Medtronic (Minneapolis) reported that data from a multi-center, prospective, randomized, single-blinded, controlled investigational study using its neurostimulation system to stimulate the occipital nerves as a potential approach to treating medically refractory chronic migraines will be presented during a late-breaking session at the annual scientific meeting of the American Headache Society. In the study, thin lead wires were placed under the skin near the occipital nerves, which arise from the spinal cord and branch out across the back of the head carrying sensory signals from that region to the brain. The leads were connected to an implanted Medtronic neurostimulator that delivered controlled electrical pulses to the occipital nerves. Patients were randomized to three groups to receive: either a neurostimulator and have the ability to control the level of stimulation; or a neurostimulator as part of a device control group; or only standard medical management instead of an ONS implant. A positive response was defined as at least a 50% reduction in the number of headache days in a month, or a reduction in the pain intensity of at least three points on a standard 0-10 pain scale.
• The Certification Commission for Healthcare Information Technology (CCHIT) said that Misys (Raleigh, North Carolina) MyWay Version 2008 is CCHIT-certified, and meets the commission's ambulatory electronic health record (EHR) criteria for 2007. Ambulatory EHRs are designed for physician offices and clinics where most Americans get their healthcare. The Misys MyWay solution, available as both an on-demand and on-premise product, offers capabilities for EMRs, practice management and claims management.
• MIV Therapeutics (Atlanta) said that its Protea ultra-thin cobalt-alloy bare metal stent has excelled in animal studies. The Protea is the company's next-generation bare metal stent with a strut thickness of 65 microns, a fixed geometry and uniform cell size for homogeneous delivery of drug to the local tissue, and a superior surface finish when compared to currently available cobalt alloy stents. Animal results showed that the Protea is statistically superior to one of the best and most deliverable cobalt-alloy bare metal stents on the market today.
• Monogram Biosciences (South San Francisco, California) said that, effective July 15, the HERmark Breast Cancer Assay will be available to physicians throughout the U.S. for assessment of HER2 status in patients with breast cancer. HERmark provides a precise and quantitative measurement of HER2 total protein and HER2 homodimer levels and will be offered as a CLIA-validated assay through Monogram's CAP-certified clinical laboratory. Physicians currently use semi-quantitative measures to determine HER2 status as an indicator of HER2 protein over-expression or HER2 gene amplification to determine whether or not to prescribe Herceptin. Inaccurate measurements of HER2 status may lead to inappropriate therapy selection. HERmark is a diagnostic that accurately quantifies HER2 total protein levels and HER2 homodimerization in patients with breast cancer. HERmark is a CLIA-validated assay that is performed exclusively in Monogram's CAP-certified clinical reference laboratory in South San Francisco. Robust, accurate, sensitive and reproducible measurements of HER2 status are reported to physicians with a turnaround time of seven days.
• Neoprobe (Dublin, Ohio) said it has introduced an enhanced gamma detection control unit, the Neoprobe GDS (Model 2300), in connection with the company's marketing partner, Ethicon Endo-Surgery. The Neoprobe GDS control unit contains internal circuitry that enables it to communicate with Neoprobe's other wireless probes without the necessity of an external adapter. Neoprobe's wireless probes are available with either straight or angled tips and can also be used with all previous models of the company's neo2000 control unit (Models 2000, 2100 and 2200) using an external serial port adapter.
• NewCardio (Santa Clara, California) reported the results of its second external validation study of QTinno (the NCE2 Study). The study was led by an independent industry leading cardiac safety expert with extensive experience in pharmaceutical clinical trials. The NCE2 study evaluated the accuracy, precision and speed of NewCardio's lead product, QTinno, in producing fully automated measurements of drug-induced QT prolongation, a key cardiac safety indicator. QTinno is a software suite that provides automated, comprehensive analysis of QT intervals and other ECG-based cardiac safety for the pharmaceutical industry and drug regulators. NewCardio is a cardiac diagnostic and services company focused on the development of a proprietary platform technology to provide higher accuracy to, and increase the value of, the standard 12-lead ECG.
• Nikon Instruments (Melville, New York) introduced its new WES-3000 wafer edge Inspection Tool, designed to identify defects often experienced with immersion lithography as well as other IC manufacturing processes. The WES-3000 incorporates high-throughput, in-line inspection with a review station featuring high-resolution and clear-color images for fast assessment of unknown defects. The WES-3000 has the ability to review the wafer edge area based on the KLARF file input. KLARF converts the coordinates from the wafer inspection tool to wafer edge coordinates to help users understand the relationship between near edge defects and edge defects. Additionally, the WES-3000 features a newly developed illumination system that lights up the wafer edge surfaces to more easily identify defects. Topcoat film boundary position at bevel can also be precisely measured through an Apex camera at the wafer edge.
• NovaBone Products (Jacksonville, Florida) has released a new form of the synthetic bone graft, NovaBone Putty (bone graft substitute). NovaBone, a calcium-phosphate silicate, goes through an ionic dissolution process that signals the body to send more precursors to the wound site earlier and forms an apatite surface layer that acts as a framework for osteoblast attachment and new bone formation. This results in an increase in osteoblast function over the first few weeks. The FDA has approved the term osteostimulation to describe Nova Bone's capability. NovaBone is the only synthetic that is osteostimulative, directly increasing the proliferation and activity of osteoblasts, the cells responsible for new bone growth. This results in more extensive early bone formation than seen for other synthetic graft materials when evaluated during in vivo testing.
• OBS Medical (Carmel, Indiana) said that its predictive patient safety technology, Visensia, was the focus of a study and peer-reviewed paper published in the June 23 issue of Archives of Internal Medicine. The company said the findings support its data fusion platform a validated technology that fuses multiple vital signs into one predictive and actionable index. It said that this approach is more reliable and timely than manual scoring systems and improves single-channel vital sign monitoring and its associated alarms. The paper provided evidence supporting Visensia's ability to detect clinical instability early and thereby avert a clinical crisis.
• PatientKeeper (Boston) said that its Meditech customer base has grown to more than 200 hospitals, representing a significant portion of the hospitals running Meditech in the U.S. The Physician Information System gives physicians a modern browser-based view of patient data on tablets, laptops and PCs, and offers a mobile companion that runs on most major Smartphones and PDAs. PatientKeeper's technology connects disparate systems that physicians typically access throughout their workday into a single physician portal. The PatientKeeper Portal enables providers to review clinical data from multiple sources including lab and test results, EKG, PACS, fetal monitoring, ambulatory EMRs and medication histories; hand off patients to other physicians at the end of a shift; and electronically sign medical record documentation. PatientKeeper makes integrated physician information systems.
• Pinnacle Data Systems (Columbus, Ohio) reported general availability of its newest compact computing board, the COMX-S1 COM express module. This powerful embedded computer-on-module (COM) features mobile AMD technologies, including single- and dual-core AMD Sempron processors and AMD Turion processors and the AMD M690 chipset. Designed to the modern industry-standard known as COM express, the PDSi COMX-S1 module enables OEMs to bring to market their embedded solutions, including providing custom I/O requirements, without the difficulty of developing the complex core circuitry of the computer.
• Radi Medical (Uppsala, Sweden) reported improvements to its latest-generation pressure-sensing guide wire, PressureWire Certus. The upgraded PressureWire Certus features a new ergonomically designed proximal connector which provides three key advantages for physicians. The new entry funnel allows for wire reconnection into the proximal connector, while also exhibiting less insertion friction. In addition, the new locking cap provides positive reinforcement when the wire and the connector are locked in place via a user intuitive on and off twist function.
• Realtime Technologies (Dublin, Ireland) introduced Shimmer, a hardware research platform designed for wearable health sensing in both connected and wireless environments. Shimmer — which stands for Sensing Health with Intelligence, Modularity, Mobility, and Experimental Reusability — uses a technology that Realtime has licensed from Intel Corp. The platform features a 2GB removable storage capacity and low-power standards-based wireless communication technologies that enable standalone applications such as robust motion capture. Shimmer can also stream data to other devices to expand the scope of research applications.
• Rosetta Genomics (Jersey City, New Jersey) said that the results of a study conducted by its scientists and collaborators and describing the use of microRNAs in accurately differentiating primary from metastatic tumors of the brain, have been published online in the peer-reviewed journal Brain Pathology. The findings demonstrate microRNAs' potential to act as effective biomarkers that may be applied in a diagnostic test designed to identify primary tumors in patients with brain cancers.
• Seal Shield (Jacksonville, Florida) has begun shipping a new family of fully submersible, 108 key, International keyboards with Silver Seal antimicrobial protection to help reduce the risk of worldwide cross contaminations, including Norovirus and the "superbug," MRSA. According to the company, the Silver Seal international keyboard is the world's first 108 key, multi-language keyboard to be dishwasher safe and embedded with Silver Seal Antimicrobial protection. The Silver Seal antimicrobial devices use all natural, pure silver ions which are embedded in the plastic to create a safe and effective, inorganic, antimicrobial solution.
• Sharps Compliance (Houston) launched a larger version of its flagship product, the Sharps Disposal By Mail System, which it said is designed as a safer and more efficient alternative for medical waste pick-up. The 18-gallon system (model number 11800) can be used to collect all of the medical waste including red bag (biohazard) waste as well as existing sharps containers located in each examination room. The product is permitted by the U.S. Postal System for transport to the Sharps medical waste disposal facility located in Carthage, Texas.
• Smiths Detection (Edgewood, Maryland) reported the launch of SmartBio Sensor (SBS), a real-time detector for biological agents or airborne toxins. SBS provides a visual or audio alarm when a bio-threat is detected and classifies the agent by threat category. SBS takes continuous samples of the air, trapping bio-agents on to coupons. The onboard computer then classifies the threat and triggers the alarm. Bio-agents are retained for confirmatory analysis and archiving. SBS also has an onboard particle counter to maintain a low response to natural chemical and biological interferents in the air. Smiths Detection is part of the Smiths Group. It provides integrated security solutions for customers in civil and military markets.
• Splintek (Kansas City, Missouri) reported that the SleepRight dental guard has received over-the-counter (OTC) clearance from FDA. According to the FDA, the SleepRight dental guard is indicated for protection against nighttime teeth grinding called bruxism. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxism or grinding. The SleepRight is a "no-boil" dental guard, which combines self-adjust technology for an individual custom fit.
• Summit Doppler Systems (Golden, Colorado) introduced an upgrade to the Vista AVS, a full-featured arterial physiologic exam system. The new Vista AVS has advanced features, one of which allows clinicians to perform the ankle brachial index (ABI) exam for the diagnosis of peripheral arterial disease (PAD) in the seated position, the patent-pending Seated ABI. The ABI exam, which compares systolic blood pressures obtained at the ankles and arms, was traditionally performed with the patient in the supine position to prevent error from hydrostatic pressure. This position requirement made the exam difficult for patients with disabilities or mobility impairments. Recent studies have shown these patients have reduced access to many diagnostic exams. The new Vista AVS calculates ABI values for seated patients by compensating for the effects of gravity on the lower extremity pressure.
• Texas Instruments (TI; Dallas) reported a new fully integrated analog front end (AFE) for portable ultrasound equipment. The second device in TI's AFE58xx family for the medical ultrasound market, the AFE5804 is specifically designed for ultrasound systems that require low power and small size. The AFE5804 features102 mW/channel at 1.25 nV/rtHz at 40 MSPS. The eight-channel device contains a low-noise amplifier, a voltage controlled attenuator, a programmable gain amplifier, a low-pass filter and a 12-bit, 10 MSPS to 50 MSPS analog-to-digital converter with LVDS data outputs.
• ThermoGenesis (Rancho Cordova, California) said it has received authorization from the FDA to begin marketing its MarrowXpress device for use in a clinical laboratory setting or intraoperatively for preparation of a cell concentrate from bone marrow. Bone marrow derived stem cells are the dominant source of stem cells studied in regenerative medicine clinical trials for treating several large patient population diseases and injuries including blood disorders, ischemic heart diseases, peripheral artery diseases, and diabetes.
• Trumpf Medical Systems (Charleston, South Carolina) has introduced what it said is the first in-light high-definition (HD) operating room camera. The TruVidia HD captures and transmits images with 1080 lines horizontal resolution and 2 million pixels. Images, captured in wide-screen format, can be transmitted for telemedicine applications and displayed on screen for education. Remote consultations can be conducted with a greater degree of confidence as the HD images essentially place the remote physicians in the OR. The TruVidia HD is integrated into the central handle of the Trumpf iLED surgical light. The camera also is available on a separate arm. Camera functions, including zoom and rotate can be controlled directly from the sterile field or from the control panel. Captured still images and even entire video sequences can be shared and archived on USB memory sticks.
• Vermillion (Fremont, California) said it has submitted a 510(k) pre-market notification application to the FDA requesting regulatory clearance of its ovarian tumor triage test known as OVA1. Previously, the OVA1 prospective clinical trial met its primary endpoints, indicating that the test is capable of stratifying women with pelvic masses into high- and low-risk categories to help determine whether the patient should be referred to a specialist prior to surgery. Vermillion is a molecular diagnostics company.
• Vistakon (Jacksonville, Florida) introduced Acuvue OASYS brand contact lenses for astigmatism. The OASYS for Astigmatism combines the accelerated stabilization design (ASD) technology of Acuvue Advance brand contact lenses for astigmatism, with senofilcon A, the silicone hydrogel material of Acuvue OASYS lenses. The lens also features Hydraclear Plus, the improved formulation of the Hydraclear technology that combines high performance base materials with a moisture-rich wetting agent.