Toshiba America Medical Systems (TAMS; Tustin, California) last month introduced a fourth-generation, contrast-free imaging technique, Time and Space Angiography (TSA).
Mark Totina, product manager for MRI at TAMS, told Biomedical Business & Technology that the TSA technique is designed to create images that show dynamic blood flow without using contrast agents.
"We are now able to electronically tag the blood and then start watching it as it flows so now we're seeing dynamic information over time, watching the blood flow through an organ without the use of contrast ... it's dynamic flow," Totina said. "Before there was no way to see that blood flowing in motion over time without the use of contrast."
TSA has a variety of clinical benefits to improve both diagnostic confidence and patient care and safety, Toshiba said. The technique builds on the company's Time-Spatial Labeling Inversion Pulse (Time-SLIP) technique, especially useful for patients with compromised circulations and renal flow problems, the company noted. It features an extremely high temporal resolution and a continually changing inversion pulse time, creating dynamic images showing blood flow in motion.
Toshiba is calling its new TSA its fourth-generation, contrast-free imaging technique, but Totina said the product is a "close cousin" to the company's Time-SLIP technique and could also be considered a second-generation technique to Time-SLIP.
Time-SLIP, he said, is useful for evaluating hemodynamic velocity, functional assessments, and visualization of vascular structures.
In patients with symptoms of stroke, TSA is intended to show blood flow into the brain and clearly display the area being impeded, which aids physicians in faster, more accurate diagnosis. For neurologists, the use of TSA will enable the diagnosis of cerebral spinal fluid diseases non-invasively, according to Toshiba.
The company also offers Fresh Blood Imaging, a non-contrast imaging technique introduced in 1998, and Contrast-free Improved Angiography, also a non-contrast imaging technique.
Totina said the company's newest non-contrast imaging technique is intended to benefit the patient first and foremost, and then the clinician "because now for the first time ever they are able to see dynamic flow non-invasively."
Elsewhere in the product pipeline:
- Abaxis (Union City, California) said that the FDA has granted waived status under CLIA regulations for four additional analytes, which subsequently allows the waived status of three additional complete chemistry panels, including the comprehensive metabolic panel, basic metabolic panel and electrolyte panel. The four 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 makes point-of-care blood analysis systems.
- Affymetrix (Santa Clara, California) reported full commercial launch of Affymetrix GeneChip command console (AGCC) software, one part of a software suite that enables researchers and clinicians to extract and analyze microarray data faster than ever before. The set of integrated instrument control and data organization tools supports all cartridge-based GeneChip arrays with a file-based system designed for easy data sharing, a streamlined workflow and ease of use. Affymetrix GeneChip command console software provides a set of tools for instrument control and data organization used in the processing of GeneChip probe arrays. AGCC calculates a single intensity value for each probe cell delineated by the grid, enables sample and array registration, instrument control for the Fluidics Station 450 and the GeneChip Scanner 3000 scanner as well as automatic and manual image gridding. Besides these core features, the flexible platform provided by AGCC enables customized, automated and integrated workflows with a variety of laboratory information management systems.
- Align Technology (Santa Clara, California) reported the launch of Vivera retainers, a subscription-based program that delivers clear, fresh retainers to orthodontic patients every three months for one year. Vivera retainers are made with the same technology as Invisalign aligners, which employ 3-D digital imaging, proprietary clear thermoplastic material and advanced fabrication technology to create a strong retainer with a precise, comfortable fit. Align said its lab tests show that Vivera's thermoplastic material is more than 30% stronger than other leading clear retainer materials, with that strength a key to retaining teeth in their final position.
- Amedica (Salt Lake City) said the FDA has granted 510(k) clearance to Amedica's Valeo cervical plate system. The system is intended for anterior screw fixation at the C2 through C7 vertebral bodies of the cervical spine. The implant and related instruments are designed to facilitate placement of the cervical plate and ensure proper angling and insertion of the screws into the vertebrae in a single step, to achieve a consistent supplemental fixation outcome. Amedica is focused on the development of silicon nitride ceramic technologies.
- AngioDynamics (Queensbury, New York) reported results from a 10-year study showing three-year and five-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 five-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 devices used for the minimally invasive treatment of cancer and peripheral vascular disease.
- ArthroCare (Austin, Texas) reported the launch of Quantum, a platform for arthroscopic surgery that it said would provide surgeons with "the most advanced technology available to help improve clinical outcomes." The company also released new versions of its two Coblation wands — Super TurboVac and Super MultiVac — now equipped with finger switches and work with the Quantum controller to provide surgeons with more flexibility. The Quantum controller is compatible with all existing Coblation wands. The Quantum controller powers Coblation wands that offer surgeons a variety of angles and electrode configurations to perform arthroscopic surgery in any joint. ArthroCare said Coblation wands provide a "larger and more aggressive" plasma layer at lower power settings than other radiofrequency devices, "resulting in faster ablation speeds with less total energy delivered to the joint in order to preserve healthy surrounding tissue." Arthrocare develops minimally invasive surgical products.
- Astra Tech (Cambridge, Massachusetts) reported the availability of the Atlantis Abutment in Zirconia for Astra Tech OsseoSpeed 3.5/4.0 (small implant-abutment connection size with aqua color-coding) and 4.5/5.0 (large implant-abutment connection size with lilac color-coding) implants. In addition, the emergence profile of Atlantis Abutments for Astra Tech OsseoSpeed implants begins close to the implant interface so that even in cases with minimal soft tissue, optimal esthetic results can be achieved. The conical shape extends past the implant shoulder to create a tight seal at the implant/abutment junction. Astra Tech makes dental implant tools.
- BioSphere Medical (Rockland, Massachusetts) said that the Centers for Medicare & Meddicaid Services has issued its Final Rule regarding hospital outpatient reimbursement for uterine fibroid embolization (UFE) and will increase such reimbursement by 113% to $5,639 per procedure from $2,642 per procedure beginning Jan. 1. This increase in reimbursement follows CMS's acceptance of a recommendation made by the Ambulatory Payment Classification (APC) Panel that CMS consider reassigning CPT code 37210, which was created for UFE effective Jan. 1, 2007, to APC code 0229. APC code 0229 includes minimally invasive interventional procedures with clinical and resource characteristics more consistent with those of UFE. Such procedures include those that utilize intravascular catheters, imaging guidance, and implantable devices. In addition, the procedure room time and recovery period for UFE is comparable to the other procedures under APC code 0229. BioSphere makes bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations.
- Bruker AXS (Madison, Wisconsin) reported its new Microstar Ultra II, the newest version of the Microstar Ultra ultra-bright X-ray source for structural biology. Its new Ultra Focus electron optics give an enhancement in intensity equivalent to a doubling of the anode rotation frequency and thus produce an extremely high intensity X-ray beam, more than 30 times brighter than a conventional rotating-anode generator. Bruker AXS makes products for life science, materials research and industrial X-ray analysis.
- Cogon Systems (Pensacola, Florida) has completed deployment of the health information exchange (HIE) for South Florida known as the South Florida Health Information Initiative (SFHII; Miami). Authorized physicians and staff of participating providers who undergo a training session will be able to search for patient data from multiple healthcare organizations. SFHII uses the "community moment of care platform," a Microsoft .NET connected platform using Windows communication foundation (WCF). The system provides the framework for interoperability and can be extended to include additional providers, payers and ancillary services to increase functionality and depth of data. The Health Foundation of South Florida, a not-for-profit public charity, provides organizational support to the SFHII.
- Collagen Matrix (Franklin Lakes, New Jersey) reported FDA clearance of its SynOss synthetic mineral bone graft material intended for use in oral surgical applications involving bone repair. SynOss is an osteoconductive calcium phosphate based bone graft material with an apatite structure similar to that of human bone. Unlike hydroxyapatite materials, SynOss has a carbonate apatite structure which is comparable to the mineralized matrix structure of human bone. The company said the similarity in structure between SynOss and natural bone mineral allows for SynOss' in vivo resorption and remodeling profile to mimic that of natural bone. Collagen Matrix is a collagen- and mineral-based biomaterials company.
- C. R. Bard (Murray Hill, New Jersey) said that it has received FDA clearance to market its Agento IC silver-coated endotracheal tube. The clearance includes claims for the reduction of microbiologically confirmed ventilator associated pneumonia (VAP). The company said that 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.
- Delcath Systems (New York) said the FDA has notified it that patient enrollment may resume in the Phase III and Phase II clinical trials of the Delcath System. Current and prospective clinical investigation sites have been notified that study accrual can be resumed immediately. This decision follows Delcath's meeting with representatives of the FDA, along with the principal investigator at the National Cancer Institute. Resumption of study accrual follows a voluntary enrollment deferral reported by the company on Oct. 23 in response to an FDA inquiry into certain gastrointestinal adverse events observed in four patients enrolled in the studies of the Delcath System prior to protocol changes enacted earlier this year. During the meeting at the FDA, the principal investigator presented an analysis of the previously reported gastrointestinal toxicities and of the changes incorporated into the trial protocols to prevent a recurrence of (GI) toxicities. These changes had been previously approved by the NCI Institutional Review Board and were subsequently approved by the Data Safety Monitoring Board for the Phase III trial. The company has been notified in writing by the FDA that the studies can proceed with the amended protocol. Delcath is a developmental-stage company testing its percutaneous perfusion technology for the isolated-organ and region-specific delivery of therapeutic and chemotherapeutic agents.
- DexCom (San Diego) said that it has received FDA approval to calibrate the SEVEN, its seven-day continuous glucose monitoring system, using any FDA-cleared blood glucose meter. With this approval, patients will be able to calibrate the system without using a connection cable. DexCom expects to launch this feature to new patients near the end of 1Q08 and upgrade existing patients during 2Q08. DexCom makes continuous glucose monitoring systems for people with diabetes.
- Direct Medical Systems (San Francisco) has released a low-cost ultrasound system, the InNovaSound, a hand-held device that can be used during a typical outpatient visit. Immediate results can mean the difference between a prolonged life and a shortened one. The company said the InNovaSound system "represents progress and potential to improve the quality of the physician examinations, which has been virtually unchanged for 200 years." It said the system can provide "truly portable" ultrasound to the patients' bedside. InNovaSound also can be used to obtain more information before ordering other diagnostic tests, thus reducing the number of unnecessary tests, as well as increasing workflow efficiency and system utilization in imaging departments.
- EarlySense (Ramat-Gan, Israel) said it has received FDA clearance for its ES-16 system. The ES-16 system, cleared by the FDA, monitors heart and respiratory rates in both children and adults. The technology developed by EarlySense uses a contact-free sensor, meaning that it is not physically connected to the body of the patient. The ES-16 System eliminates patient discomfort and enables the cost-effective monitoring of patients in settings such as homes, hospitals and other clinic settings such as long term care facilities. The system is currently being evaluated at several clinical settings on patients suffering from chronic diseases, such as asthma, COPD and CHF, as well as at acute-care facilities, on critical-care patients and patients hospitalized for various medical and post-operative conditions. EarlySense intends to begin selling the product, to be named EverOn, in 2008, following a number of beta-site evaluations in both Israel and the U.S. EarlySense describes itself as a developer of "smart systems" for monitoring changes in a patient's clinical condition.
- Endocare (Irvine, California) said that the Centers for Medicare & Medicaid Services have increased its hospital outpatient and ambulatory surgical center reimbursement rates for cryoablation treatments for prostate cancer. The new rates, which were proposed in August and will go into effect in 2008, were confirmed on Nov. 1 and will be published in final regulations documenting these payment increases in the Federal Register on Nov. 27. Cryoablation is a minimally-invasive treatment that uses the Endocare CryoCare surgical system to precisely target, freeze and destroy cancerous tissue. Endocare is focused on the development of minimally invasive technologies used by urologists and interventional radiologists for tissue and tumor ablation.
- ExonHit Therapeutics (Paris) reported completion of a prototype of the first blood-based Alzheimer's disease test. The company said it expects to have the test certified and to provide it as a service in its GLP (Good Laboratory Practices) compliant laboratories to the pharmaceutical industry as early as 2009. This initial ExonHit test aims to identify patients suffering from Alzheimer's disease from a simple blood sample. This test is based on hybridizing nucleic acids (RNA), isolated from a blood sample, on a custom microarray produced by Affymetrix which contains sequences identified using ExonHit's patented human genome screening technology. The blood test can distinguish patients suffering from Alzheimer's disease from those suffering from bipolar disorders, schizophrenia or depression. The identified sequences (or "signature") were found to be typical in the blood of patients suffering from Alzheimer's disease can be grouped and are representative of alterations of well known metabolic functions.
- Grant Instruments (Cambridge, UK) has unveiled a new line of DNA/RNA UV cabinets/PCR workstations, including standard, economy and double units, which feature a novel patented UV cleaner-recirculator system. This UV cleaner-recirculator system increases the maximum density of UV light treating the entire internal air volume, generating 25 cubic meters per hour air flow exchange to provide aseptic conditions for a variety of molecular biology and biochemical procedures. The recirculator can also provide constant cabinet decontamination making the environment suitable for demanding applications working with DNA/RNA, infectious and viral materials such as prions. Grant Instruments makes scientific, life sciences and data acquisition products.
- iMedica (Dallas) introduced its Patient Relationship Manager (PRM) 2008 at the Medical Group Management Association (MGMA) 2007 conference in Philadelphia. PRM 2008 is the latest version of iMedica's electronic health records (EHR) and practice management (PM) solution. Imedica makes healthcare software solutions for physician practices.
- 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.
- invivodata (Pittsburgh) reported a new version of its EPX ePRO (electronic patient reported outcomes) management system, version 5.0. This system enables sponsors, monitors and site personnel who are using invivodata's ePRO solutions to more effectively manage the ePRO activities related to their clinical studies. EPX is a web-based system for monitoring and managing key functions of every ePRO study in real time, including site performance, patient enrollment and compliance, data integrity, and solution functionality. EPX offers dozens of innovative ePRO study management features to benefit trial sponsors, monitors and site personnel. Highlights of EPX include the following capabilities: facilitate site monitoring activities through user-customizable reports and concise, workflow-driven information dashboard views; reduce site workload through a proactive e-mail alert system, which highlights items needing further investigation and indicates when an action is needed; and deliver timely resolution of data discrepancies via the industry's only electronic Data Clarification Form (eDCF) system. Invivodata specializes in ePRO clinical research.
- IRIS International (Chatsworth, California) said that its sample processing division has initiated shipments of its new, high speed, horizontal centrifuge, the StatSpin Express 4. The StatSpin uses a horizontal rotor for separating gel tubes in just minutes and replaces larger and slower, batch centrifuges by reducing sample preparation time and streamlining laboratory workflow. This new product platform enables Iris Sample Processing entry into the high volume chemistry test market and further application expansion in blood and body fluids. IRIS International makes automated IVD urinalysis systems.
- JHD Group (Dallas) said that it is rolling out a new turnkey electronic medical record (EMR) and practice management system (PMS) service to enhance its ability to meet the growing demands of its clients. It will offer healthcare organizations such as hospitals, IPA's, and physician groups an option for implementing and operating a physician clinical integration solution (EMR PMS) through an ASP model which greatly reduces risk, expedites the implementation process, is competitively priced, and is sustainable over the long-term. JHD Group is a healthcare consulting group and management firm specializing in physician organizations.
- 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.
- Kerk Motion Products (Hollis, New Hampshire) reported the introduction of the Mini ScrewRail, a compact addition to the company's line of ScrewRail linear actuators. The Mini ScrewRail consists of a precision rolled lead screw, supported by sealed bearings and contained within a concentric steel guide rail, driving an integrated nut/bushing. The Mini ScrewRail is available in a .375" outside diameter, sizably smaller than typical diameters of .500" to 1.00." The Mini ScrewRail uses Kerk's Kerkote TFE coating on both the lead screw and guide rail, minimizing drag torque and extending wear life. In addition, Kerkite high performance polymers make the entire assembly self-lubricating and maintenance-free. Kerk Motion makes non-ball lead screws.
- Kensey Nash (Exton, Pennsylvania) reported the first commercial product kit shipment of its bone void filler OsseoFit Porous Tissue Matrix to Biomet Sports Medicine, the sports medicine subsidiary of Biomet. The product kit will be used to expand the clinical use of the OsseoFit device beyond a select group of sites that have had access to the product to date. OsseoFit is a implant manufactured from Kensey Nash's Porous Tissue Matrix technology, which creates foamed scaffolds suited for tissue engineering applications. The OsseoFit uses several resorbable biomaterials including a proprietary collagen formulation, synthetic polymer and ceramic. This design creates a structure that is optimized for specific types of bone void filling indications. Kensey Nash specializes in products for the endovascular, sports medicine and spine markets.
- LCA-Vision (Cincinnati) reported plans for a nationwide rollout of Advanced Medical Optics' IntraLase femtosecond technology at its LasikPlus vision centers throughout the U.S. This decision was made by LCA-Vision in conjunction with its medical advisory board following a 6-month review and clinical testing process. LCA-Vision's medical advisory board is comprised of a panel of LasikPlus surgeons who are recognized as some of the most experienced refractive surgeons in the nation. LCA-Vision first began evaluating the IntraLase technology at four of its LasikPlus vision centers this past April, and expanded the test at additional vision centers over recent months. LCA-Vision makes laser vision correction services under the LasikPlus brand.
- LeMaitre Vascular (Burlington, Massachusetts) reported the commercial launch of the TT Tortuous Tracker Delivery System, the introducer for LeMaitre Vascular's EndoFit and UniFit Aortic Stent Graft product lines. The TT system is designed to simplify stent graft implants by requiring reduced deployment force, providing the physician with increased control over placement of the stent graft in the aorta. The TT system offers flexibility and an improved coating to increase maneuverability through blood vessels and a three-part valve system to minimize blood loss during the medical procedure. The TT system also provides better visualization during the procedure and a more ergonomic design. LeMaitre Vascular makes devices for the treatment of peripheral vascular disease.
- Medtronic (Minneapolis) said that it has received FDA clearance for the Complete SE (self-expanding) biliary stent system, which is indicated for use in the palliative treatment of malignant neoplasms in the biliary tree cancerous tumors in the bile duct that can compromise digestion by restricting the flow of digestive fluids. U.S. sales of the new biliary stent will begin in a wide size range, with diameters of 4 mm 10 mm and lengths of 20 mm 150 mm. The company said that bench testing has shown the Complete to be accurate in terms of stent placement.
- MGB Endoscopy (Berlin, Germany), in partnership with AltaSens (Thousand Oaks, California), reported the introduction of the MD-V camera, a high-definition video surgical instrument that delivers images with high resolution and high sensitivity at a real-time 60-fps frame rate. The companies said the MD-V is the world's first HD endoscopy camera based on CMOS sensor technology, and it meets all practical and regulatory requirements. The MD-V can be deployed in even the most sterile operating rooms. The instrument head is fully qualified to sustain repeated sterilization cycles using disinfectant solutions and steam sterilization. The camera leverages AltaSens' ProCamHD 2462 imaging System-on-Chip sensor, including its full video resolution of 1280 (H) x 720 (V) pixels, integrated 12-bit A-to-D conversion, and low-noise delivery of the full HD video via its patented Tapered-Reset technology. For the convenience of hospitals with different requirements, the camera supports HDMI, SDI, Composite and Y/C output formats.
- Microtek Medical Holdings (Alpharetta, Georgia) reported the release of StethoClean, a device that offers clean, disposable stethoscope covers to protect each patient from germs and infectious disease. StethoClean attaches to the stethoscope, making 20 single-use stethoscope covers easily accessible to healthcare professionals as it travels with them throughout the day. According to the Annals of Emergency Medicine, stethoscopes carry disease from one patient to another, spreading everything from the common cold and flu to life-threatening hospital "superbugs" such as MRSA and other staph infections. Microtek specializes in barrier infection control solutions for the healthcare environment.
- Misonix (Farmingdale, New York) reported the introduction of the Sonicator 4000, its new digital sonicating product, which is an ultrasonic liquid processor. The latest product from Misonix's laboratory and scientific segment, the S4000 introduces additional features from the previous sonicator, the S3000. It comes with an on-screen, self diagnostic help program along with other technologically enhanced digital features for ease of use and technician interface. The ultrasonic processing capabilities of sonicators are used to enable research of cellular mechanisms, properties and genetic code. Devices are used for cell disruption, shearing DNA, creating nanoparticles, and other applications. Misonix makes therapeutic ultrasonic medical devices, and laboratory equipment.
- Monogram Biosciences (South San Francisco, California) said that the California ADAP program under the California Office of AIDS has established coverage and reimbursement for Monogram's Trofile Assay. This coverage will be administered by the Public Health Service Bureau, the California ADAP program's pharmacy benefit manager. Monogram introduced Trofile in August, upon FDA approval of Pfizer's Selzentry (maraviroc), and since then, roughly 2,000 tests have been requested. Some 1,200 tests have been performed, of which about 400 have been for clients and payers for whom reimbursement arrangements are in place, and for which revenue is recorded. Monogram makes products to guide and improve treatment of serious infectious diseases and cancer.
- Multi Radiance Medical (Solon, Ohio) reported the introduction of TerraQuant, an FDA-cleared laser device that offers relief of chronic and acute pain. TerraQuant incorporates multiple radiances into one technology. These radiances include super pulsed laser, pulsed infrared, red light and static magnetic field enabling deep tissue penetration, from the surface to five inches deep. In a clinical study, TerraQuant was shown to have an 88% positive effect in relieving pain caused by arthritis in small and medium joints. TerraQuant is FDA-cleared for temporary relief of joint pain and arthritis, muscle spasm and stiffness, for promoting relaxation of muscle tissue and increasing local blood circulation. Multi Radiance makes therapeutic devices.
- Nephrocor (Glen Allen, Virginia) reported availability of RenalVysion, the non-invasive urine-based test for early diagnosis of kidney disease. RenalVysion identifies and measures urinary sediment findings not detected in routine urinalysis. These highly specific results allow anatomic localization of injury in the kidney and the severity of disease. RenalVysion incorporates technology that has up to 91% accuracy in diagnosis according to comparative studies with kidney biopsies for glomerular disease. Nephrocor is an anatomic pathology laboratory exclusively serving nephrologists throughout the U.S.
- 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.
- Rapid Pathogen Screening (RPS; Sarasota, Florida) reported that the American Medical Association will issue a new current procedural terminology (CPT) code that will cover the RPS Adeno Detector, effective Jan. 1, 2008. CPT Code 87809 — a code for "Infectious agent antigen detection by immunoassay with direct optical observation; Adenovirus" — will cover the RPS Adeno Detector. The RPS Adeno Detector is a point-of-care test available for conjunctivitis — more commonly known as "pink eye." Rapid Pathogen Screening makes point-of-care diagnostic devices for ocular diseases.
- Renal Solutions (Warrendale, Pennsylvania) reported that a home-use clinical research trial has begun using sorbent technology. The study presents the opportunity for 25 dialysis study participants to evaluate the ability to self-administer extended duration dialysis in the home when using the company's Allient Sorbent Hemodialysis System. The Allient enables hemodialysis using only 1.5 gallons of drinking water to provide a convenient therapy option requiring no plumbing modifications to a person's home. It is the only system that uses Sorbent Management for Advanced Renal Replacement Therapy (SMARRT). Renal Solutions said SMARRT therapy is based on more than 35 years of proven dialysis, using a gentle, patient-driven technology that enables flexible treatment options including extended duration dialysis therapy resulting in greater patient freedom and control. Renal Solutions provides sorbent hemodialysis products and services.
- Royal Philips Electronics (Andover, Massachusetts) reported North American commercial availability of the next release of Philips Xcelera, a clinically-advanced, multi-modality image management, physician reporting and information distribution system. Philips' enhanced Xcelera solution organizes and provides access to images and data from key cardiology subspecialties, including echocardiography, cardiovascular ultrasound, nuclear cardiology, cardiac CT, cardiac MR, cardiac catheterization, and electrophysiology, as well as direct links to ECG studies. The Xcelera solution facilitates the process of documenting the patient's medical condition, as derived from these clinical tests, into a secure, centralized electronic system. As the patient moves through the care continuum, Xcelera manages and distributes the diverse test results, supporting collaboration amongst physicians to achieve better clinical outcomes.
- Siemens Medical Solutions (Malvern, Pennsylvania) said it has expanded the SOMATOM Definition family of computed tomography scanners (CT) with the first CT that adapts to patients with the most challenging clinical situations. The SOMATOM Definition family consists of the SOMATOM Definition Dual Source and the new SOMATOM Definition AS, an adaptive scanner. The Definition AS technology couples multiple components in a dynamic manner: a large-volume coverage area with a 200-cm scan range, 78-cm gantry bore and the ability to add a high-capacity 650-lb patient table. The Definition AS will be available in 40-slice, 64-slice and 128-slice configurations. With Adaptive 4D Spiral, the Definition AS is able to address functional imaging (perfusion images of blood flow over time) specific to the organ being imaged. The SOMATOM Definition Dual Source has a dual X-ray tube and dual-detector design, the Definition routinely provides images at twice the temporal resolution, twice the speed and twice the power of single-source systems.
- SonoSite (Bothell, Washington), reported the introduction of the S-Cath visualization tool, a specialized ultrasound device designed to meet the specific point-of-care imaging and procedural guidance needs of interventional radiologists and cardiologists. Its available suite of curved, linear and phased array transducers cover a range of guidance for interventional procedures such as line placement, biopsy, dialysis access, stent placement, femoral and other vascular access and fluid drainage as well as abdominal and cardiovascular imaging applications. With standard VESA-compliant mounting capabilities, the system offers a zero footprint option for crowded interventionalist suites and cath labs. It can be mounted adjacent to other imaging modalities and moved in and out of the physician's line of sight as needed. SonoSite makes hand-carried ultrasound devices.
- SunTech Medical (Morrisville, North Carolina) reported the release of the SunTech 247 diagnostic station. The company said the device "bridges the gap in price and capability between manual blood pressure gauges and vital signs monitors." It is available in the U.S. exclusively through IMCO and NDC members and worldwide through SunTech authorized distributors. The SunTech 247's modular design allows the addition of temperature and SpO2 modules and is available in a variety of mounting configurations, including wall, table or mobile stand. SunTech Medical makes blood pressure technology equipment.
- Talyst (Bellevue, Washington) unveiled the latest generation of automation systems for central-pharmacy operations. AutoPharm 3, Talyst's software platform, links and unifies disparate systems of various manufacturers, all to enable the central pharmacy to achieve enhanced patient safety, improved operating efficiency and precise pharmacy control. Throughout the hospital, medications can be tracked from the point of entry to the automated dispensing unit or patient care area. New features of the AutoPhram 3 include: broader inventory control, chain of custody, mobile computing, and productivity reporting. Talyst provides automated systems to hospitals and other centralized pharmacies.
- VertiFlex (San Clemente, California) reported commercial introduction of the Silverbolt MIS screw system to the U.S. market. The system will serve as a platform for percutaneous and mini-open fusion procedures. Designed as a percutaneous geometric approach, the Silverbolt system was engineered to meet the concerns of surgeons. A pre-lordosed ball-end rod is delivered into the screw head in a single step, while a draw bridge mechanism pushes the rod into the adjacent screw. No additional incisions are needed and the company said the design ensures alignment even in the more difficult L5-S1 cases, while assuring accuracy of the rod delivery during a minimally invasive procedure. Silverbolt also allows for reduction of up to Grade 2 spondylolithesis percutaneously. VertiFlex makes minimally invasive and motion preservation technologies for disorders of the spine.
- Visiogen (Irvine, California) reported the closure of enrollment in its Phase III study of the Synchrony dual optic accommodating intraocular lens. This study is evaluating the safety and efficacy of the device and the potential for functional near, intermediate and distance vision without the use of glasses in patients after cataract surgery. The Synchrony system is self-contained and ready for use without the need for lens handling by means of a preloaded injector. The dual optic lens is designed to be inserted through a 3.6 mm to 3.8 mm clear-corneal incision. The single-piece, 3-D lens unfolds in the eye upon insertion and features two optics connected by a spring system. The springs connect a 5.5-mm high power anterior optic and a 6-mm minus power posterior optic. The spring action moves the front optic and changes the eye's focus from near to far. Visiogen makes products for cataract and refractive patients.