| BioWorld

BB&T

Annual visits to an optometrist's office aren't usually very a high on a diabetic patient's to-do list. In fact, of the 18 million to 20 million people with diabetes in the U.S., it is estimated that only half get annual examinations assessing retinal risk.

But assessing that particular risk is considered to be the first and foremost must-do — or else — for these people, since more than 80% of all those who have had diabetes for 15-years or more are stricken by diabetic retinopathy, a disease of the retina that eventually leads to blindness and considered a leading cause of blindness in the U.S. And more than 90 % of these cases can be eliminated with the proper screening and subsequent treatment.

The problem? — as with many physician recommendations — poor patient compliance, failure to follow through on referral for an ophthalmologic assessment.

Digital Health (Wake Forest, North Carolina) is looking to change that with the PMA approval it won last month for its Retasure software that enables even a non-clinician in an eye care facility to do the retinal risk assessment. The primary feature is its compatibility with most non-mydriatic fundus cameras to detect symptoms of diabetic retinopathy. A non-mydriatic camera provides sharp color images of the inside of the eye. The camera's software allows for viewing of the stereo images without 3-D devices or other visual aids.

Diabetic retinopathy, which has no obvious initial symptoms, occurs when blood vessels form at the back of the eye and bleed onto the rods and cones within the eye. The longer a person has diabetes, the higher risk of the disease developing.

According to statistics nearly all patients with Type I diabetes, and more than 60% of patients with Type 2 diabetes, have some degree of retinopathy.

There are three treatments for the disease which are said to be very effective in reducing vision loss. These treatments are laser surgery, injection of tramcinolone into the eye and virectomy.

"[Diabetic] retinopathy is a disease that is in the background right now," Marc Winchester president, North America and board director of Digital Health, told Biomedical Business & Technology. "It's a disease that becomes much more talked about as diabetes becomes a problem in the United States."

Winchester said the software — as of now in only a handful of sites, including North Carolina, Texas, Ohio and Pennsylvania — is used to capture digital images of diabetic patients' retinas in a non-invasive procedure that takes just a few minutes. These images are then transmitted through a secure HIPPA-compliant network to a board-certified ophthalmologist at an accredited reading center for examination. It can be operated by non-clinicians, is non-invasive and requires no dilation of the eye.

"The process takes seven minutes," Winchester said. "The camera takes one picture of each eye."

The eye care professional will look at the retina for early signs of the disease, such as leaking blood vessels, retinal swelling, such as macular edema, pale, fatty deposits on the retina (exudates) - signs of leaking blood vessels, damaged nerve tissue (neuropathy), and any changes in the blood vessels.

"Eventually we'll have Retasure [deployed] nationwide," Winchester asserted, with confidence. "We're going to have a state-by-state initiative. FDA approval for Retasure technology platform marks a major step forward in the development of Digital Healthcare. Pre-market approval clears the way for the company to market our products and services more widely. "

The software received CE mark approval in Europe in 2000.

"The U.K. mandates diabetics to go to an optometrist and be tested for this disease because of socialized healthcare," Winchester said. "So far, more than 1.5 million patients in [Europe] have been tested through Retasure."

However, this picture differs greatly in the U.S., Winchester said, where the risk of diabetic retinopathy is seriously under-diagnosed.

"We did two diabetes fairs in Cincinnati, and we had 70 to 74 patients screened," he said. "Out of those patients we found 40 cases with retinopathy, ranging mild to severe. Of those, 10 were severe cases."

Queen City Physicians of Cincinnati was one of the first to banner a contract with Digital Healthcare to provide Retasure assessments of their patients with diabetes.

"This is an exciting development for Queen City Physicians," said Pamela Coyle-Toerner, CEO of the Queen City Physicians, in a press statement. "Retasure allows us to expand the range of care to our diabetic patients and will greatly enhance our ability to discover diabetic retinopathy in a timely — and sight-saving — manner."

Winchester says the FDA approval will launch what it is calling the start of a more aggressive distribution of its offerings and platform technology.

"The approval not only covers our retinal risk assessment products such as Retasure, but also our next-generation clinical ophthalmology technology which effectively integrates most instruments and technologies used in clinics using workflow management tools," Winchester said in a company statement. "Our reach now extends from the detection of eye disease, through diagnosis and patient outcome management."

Elsewhere in the product pipeline:

Abbott (Des Plaines, Illinois) has received a supplemental premarket application approval from the FDA for its recently introduced RealTime HIV-1 viral load test. The approval allows Abbott to market enhancements to the test, including a design feature giving laboratories the flexibility to perform HIV-1 viral load tests with smaller amounts (0.6 mL) of blood plasma. Abbott markets the m2000 system and a menu of tests throughout the world as part of a strategic alliance with Celera. The RealTime test, based on real-time polymerase chain reaction (PCR) technology, is the most sensitive HIV-1 viral load test available and the only test of its kind validated to detect and quantitate (precisely measure) the common strains of HIV-1 as well as all known genetic variations of the virus, including group O, group N, and non-B subtypes, according to the company. The assay is capable of quantitating HIV-1 in plasma down to as few as 40 RNA copies per mL, surpassing the standard of care sensitivity of 50 copies per mL. The test targets the highly conserved pol integrase region of the HIV-1 genome, giving the test its ability to detect and measure all known genetic variations of the virus.
Accuray (Sunnyvale, California) reported DA clearance of its Monte Carlo dose calculation algorithm. The Monte Carlo dose calculation method takes the probability and potential interactions for each individual photon into account when it calculates the dose being delivered by a single photon. It then considers the probabilities for each of millions of photons to generate a dose calculation for the target and surrounding structures. By integrating the Monte Carlo Dose Calculation algorithm with the CyberKnife robotic radiosurgery system, Accuray said it can provide clinicians with tools for treating lung cancer. The CyberKnife automatically tracks, detects and corrects for tumor and patient movement in real-time throughout the treatment. This enables the CyberKnife system to deliver precise, high-dose radiation, minimizing damage to surrounding healthy tissue and eliminating the need for invasive head or body stabilization frames. Accuray specializes in the field of radiosurgery.
Aethlon Medical (San Diego) said it has initiated further studies to support the use of its Hemopurifier technology in cancer care. Aethlon recently documented that the Hemopurifier, targeted to treat drug and vaccine resistant viruses, is also effective in capturing tumor derived exosomes from the blood of cancer patients. Exosomes are particles released by solid tumors, lymphomas, and leukemia, and are known to suppress the immune response in cancer patients. New studies, designed to document in vitro capture of exosomes by the Hemopurifier at time intervals up to 120 minutes, are now under way. These studies will also seek to demonstrate whether the removal of circulating exosomes by the Hemopurifier diminishes the suppression of T cell proliferation and activation by the biological fluid. Aethlon makes the Hemopurifier, a device used to treat infectious disease.
Aloka (Wallingford, Connecticut) reported the introduction of two ultrasound systems with dedicated platforms for advanced cardiac and vascular imaging, the Alpha 10 and Alpha 7. The Alpha 10 incorporates all of the standard cardiovascular features such as stress echo, TDI/strain, TEE transducers, full reporting capabilities, and DICOM networking. The Alpha 7 provides image quality for mid-level and office based imaging. It offers a suite of cardiovascular capabilities in a compact chassis for those facilities where space is at a premium. Aloka specializes in ultrasound equipment.
Asuragen (Austin, Texas) reported the launch of its new high-content microRNA (miRNA) service that enables comprehensive analysis of miRNA expression profiles from published miRNA sequences and an expanded set of unpublished candidate miRNAs, the company said. The first generation platform for Asuragen's DiscovArray miRNA expression service uses a new Ambion array that is custom-manufactured by Affymetrix and designed specifically for miRNA expression analysis. The array contains features representing validated Sanger miRBase content in combination with over 12,000 exploratory human miRNAs. Asuragen is a molecular biology service provider and oncology molecular diagnostic company.
Atrium Medical (Hudson, New Hampshire) reported the availability of its di-2-ethylhexyl phthalate (DEHP) free thoracic catheters. In keeping with the FDA recommendation that medical device manufacturers reformulate products to remove DEHP, and further suggest that all hospitals use alternatives to DEHP containing products. The company said DEHP-free catheters are its latest advance in a series of medical device innovations, built upon a strong 26 year heritage of excellence in advanced biomaterial science, all engineered specifically for improvements in patient outcomes following thoracic drainage intervention. Atrium makes chest drainage products, and chest tube insertion kits.
B. Braun (Bethlehem, Pennsylvania) reported the launch of the Stimuplex Pen, the newest product offering in its regional anesthesia product line. The pen is a non-invasive percutaneous nerve mapping device can help those administering peripheral nerve blocks quickly locate superficial nerves and identify the optimal angle and needle entry point before introducing the needle into the patient. The pen focuses a very small current from a Stimuplex HNS 11 or HNS 12 nerve stimulator, and can have an incremental benefit when used in combination with ultrasound-guided nerve technology. It can be used to identify nerves up to 3 cm in depth and is effective in localizing the musculocutaneous, femoral, ulnar, radial and median nerves for interscalene, axillary, mid-humeral, wrist and femoral nerve blocks. B. Braun specializes in regional anesthesia technology.
BodyMedia (Pittsburgh) said it has begun shipping SenseWear WMS (weight management solution) to its clinical customers. The company said that SenseWear WMS is the first ever web-based clinical weight management solution to focus on behavior therapy and is designed to improve weight loss outcomes by increasing patient adherence to behavior prescriptions. The system is designed to promote significant and sustainable lifestyle changes for weight loss and improved health by enabling health practitioners and their patients to continuously and easily monitor daily behaviors such as calories burned, nutrition and sleep. SenseWear WMS consists of the SenseWear armband for the automated tracking of activity and sleep, the SenseWear display for real-time feedback and the SenseWear WMS web site for users to upload armband data and manually track nutrition intake and weight. The solution enables practitioners to offer short-term metabolic assessment and behavior therapy programs as well as longer term weight management programs customized to the current readiness and goals of each patient. BodyMedia makes metabolic assessment and behavior therapy solutions for the treatment of obesity, diabetes and CVD.
Boston Scientific (Natick, Massachusetts) released data reflecting experience from the first 15,000 patients monitored wirelessly on the Latitude patient management system. The Latitude can detect clinical events between scheduled follow-up visits and then send the clinical event data directly to physicians. Virtually all Boston Scientific ICD and CRT-D patients are eligible to be enrolled on Latitude, according to the company. To date, more than 60,000 patients are enrolled on the system at more than 1,300 clinics across the U.S. An optional component to the Latitude is a wireless weight scale and blood pressure cuff, which is aligned with the ACC/AHA physician society guidelines that recommend monitoring weight and blood pressure. Latitude also offers custom views with clinical data to both the implanting and health care following physicians.
CAD Sciences (White Plains, New York) reported the release of a suite of motion correction (MC) algorithms that expand on the existing MC capabilities that have been embedded in CAD Sciences' products since their commercial launch. The new MC suite represents an upgrade in MC processing as compared to competitive solutions and was developed through a combination of new algorithm creation and modification of existing technologies by CAD Sciences' scientific team. The MC suite is optimized for specific scanning applications that include, among others, breast MRI, prostate MRI, lung CT and lung MRI. CAD Sciences specializes in MRI-CAD for breast, prostate and other organs.
Caliper Life Sciences (Hopkinton, Massachusetts) reported the launch of the Caliper LabChip EZ Reader series, delivering a range of products for in-house kinase profiling. The series, which complements the existing LabChip 3000 system, Caliper's system for drug discovery, includes the new EZ Reader II system, a bench-top reader to use for real-time kinetic analysis with push-button operation, and the EZ Reader system, formerly the DeskTop Profiler system. Each product in the EZ Reader series uses Caliper's LabChip microfluidic-based screening technology to yield reproducible data to help pharmaceutical researchers more confidently qualify potential lead candidates. The EZ Reader series features systems that rapidly profile compounds against a diverse kinase panel. The system features a four-sipper Caliper LabChip microfluidic device, while the EZ Reader II system provides a choice of either a 4-sipper or a 12-sipper LabChip device to run assays with up to three times higher throughput. Caliper Life Sciences provides technologies enabling researchers in the life sciences to create life-saving and enhancing medicines and diagnostic tests more quickly and efficiently.
CEVA (San Jose, California) reported that Advanced Bionics (Valencia, Califonria) has licensed and deployed the CEVA-TeakLite DSP core in its Harmony HiResolution Bionic Ear System. The CEVA-TeakLite core, used in the external (behind the ear) sound processor of the Harmony system, is a key component in providing hearing capability for severe-to-profoundly deaf individuals that would otherwise have little or no perception of sound. The device benefits from the CEVA core's support for CD-quality audio, wide input dynamic range and powerful dual-loop automatic gain control. This technology is used in the Harmony system, with its HiRes Fidelity 120 processing feature, to help cochlear implant recipients appreciate music, use the telephone, and hear in noisy environments, without needing adjustments to their processor. CEVA is a licensor of intellectual property platform solutions and DSP cores for wireless, consumer and multimedia applications.
Clinical Solutions (Basingstoke, England) reported the launch of new software for early detection and effective management of a pandemic outbreak. Bio Surveillance provides a series of algorithms which enables early detection, containment, real-time reporting and analysis of an outbreak. With its web-based platform, the system can be operated and updated in real time, by multiple users, at disparate locations. The software aims to steer healthcare professionals successfully through the complex healthcare delivery process, ensuring that patients are referred to the most appropriate level of care. The system was successfully trialed during Exercise Cumpston, Australia's largest ever health simulation exercise and one of the largest pandemic influenza exercises held globally. The application allows the clinician to quickly determine the potential presence of an infectious disease and direct the patient to take the most appropriate action. Clinical Solutions makes decision support and clinical software solutions designed to help healthcare professionals assess a patient's symptoms and direct them to the most appropriate level of care.
CompuMed (Los Angeles) reported that it has expanded its support of PACS/DICOM in its OsteoGram software. The picture archiving and communication systems (PACS) is standard for the interoperability and storage of medical imaging and typically supports the digital imaging and communications in medicine (DICOM) image format. OsteoGram 1.36 includes the capability to send images to PACS systems directly from the OsteoGram report module, as well as the ability to query and retrieve images from PACS directly. This enhances support for PACS/DICOM implementations and makes sending DICOM reports faster and easier. CompuMed is a medical informatics company that makes diagnostic software solutions.
Cook Medical (Bloomington, Indiana) said it has submitted the final module of its pre-market approval (PMA) application to the FDA for the Cook Zenith TX2 thoracic aortic aneurysm endovascular graft. Cook's PMA submission includes safety and efficacy data on about 230 patients who have been treated with the Zenith TX2 in clinical trials. Thoracic aortic aneurysms occur when the section of the aorta that runs down the chest weakens and bulges outward like a balloon. The Cook Zenith TX2, a reinforced fabric tube that is sized to the length of the aorta and covered, is used to seal off the aneurysm. The Zenith TX2 helps to relieve pressure on the aneurysm and reduce the risk of rupture. Cook speciaqlizes in manufacturing interventional devices.
Corgenix Medical (Denver) has submitted a 510(k) premarket notification to the FDA for the company's IgG Anti-AtherOx test kit. This new laboratory test uses the company's AtherOx technology to detect IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with b2-glycoprotein I (b2GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). The AtherOx technology uses oxLDL complexed with the plasma protein b2GPI. Although oxLDL has been implicated in cardiovascular disease, clinical data demonstrates that the determination of oxLDL/b2GPI complexes (AtherOx), rather than oxLDL alone, is a more physiologic and accurate way of assessing the risk of progressive atherosclerotic cardiovascular disease. Corgenix licensed this technology in 2002, and is developing additional products utilizing this platform. Corgenix makes specialized diagnostic kits for vascular diseases, immunology disorders, and bone and joint disorders.
Critical Diagnostics (New York) reported that a pivotal research paper has been published in the Journal of the College of Cardiology titled, "Measurement of the Interleukin Family Member ST2 in Patients with Acute Dyspnea: Results from the ProBNP Investigation of Dyspnea in the Emergency Department (PRIDE) Study." The results of the study demonstrate the strength of ST2 as a biomarker for risk stratification and prediction of mortality in patients who present to the emergency department with shortness of breath and suspected acute decompensated heart failure. ST2 is a mechanically-induced cardiomyocyte protein, and serum levels of ST2 have been shown to predict outcome in patients with acute myocardial infarction or heart failure. The research described in this paper illustrates that ST2 is a powerful biomarker for prediction of near term mortality in dyspneic as well as acute decompensated heart failure patients. Critical Diagnostics makes the Presage laboratory assays using ST2 for the diagnosis and prognosis of cardiovascular disease.
Diagnostic Hybrids (Athens, Ohio) reported the release of its D3 DFA Varicella-zoster virus identification kit for the qualitative identification of Varicella-zoster virus (VZV) in cell culture by immunofluorescence. The kit is for in vitro diagnostic use and uses a blend of monoclonal antibodies directed against two specific VZV proteins. The D3 is a complement to Diagnostic Hybrids' Varicella-zoster virus testing system which includes the Flocked Swab/UTM for specimen collection and transport, the H&V-Mix mixed cell culture system which allows for the rapid isolation of VZV, and now the D3 DFA Varicella-zoster virus identification kit. Diagnostic Hybrids makes diagnostic and analytical products for viral respiratory diseases, herpes virus infections, and other specific viral and thyroid diseases.
ELA Medical (Denver), a Sorin Group (Milan, Italy) company, reported the first U.S. implant in NATURE, an observational study that will enroll 1,440 patients in North America and Europe. The objective of the NATURE study is to observe the evolution of atrio-ventricular conduction disorders in pacemaker patients over a 2-year time period. Patients implanted with either ELA Medical/Sorin Group's Symphony model 2550 or Reply DR (1) dual chamber pacemakers will be included in the study. Data will be collected using AIDA+, ELA's exclusive feature that is capable of identifying different types of atrio-ventricular blocks. Symphony pacemakers are equipped with AAIsafeR, a unique algorithm designed to deliver right ventricular pacing only when needed. REPLY pacemakers incorporate the same algorithm. ELA Medical specializes in the design and
Firstlight Networks (Tustin, California) reported the introduction the Lumen imaging system with UL 60601-1 compliance. This technology is designed to allow users to convert that modality into a digital capture device in order to collect patient image files for further diagnosis or archival purposes. The Lumen imaging system provides hospitals, surgical centers, and medical practices with the ability to extend the functionality of their existing medical equipment by transforming them into digital capture devices. Firstlight provides specialized solutions for the medical and IT marketplaces.
FlowCardia (Sunnyvale, California) reported the completion of enrollment into the Peripheral Approach To Recanalization In Occluded Totals (PATRIOT) study. The study was designed to assess the safety and efficacy of the peripheral line of Crosser catheters in lower limb chronic total occlusions (CTOs). The Crosser is a rapid exchange catheter delivered over standard .014" and .018" guidewires to the site of a CTO. Using high frequency vibration, the Crosser is designed to safely and quickly cross CTOs allowing for subsequent debulking, balloon angioplasty and stent placement. FlowCardia is a privately held medical device company that makes CTO recanalization systems.
Illumina (San Diego) reported the introduction of the Infinium HumanHap550-Duo BeadChip, the company's fourth multi-sample DNA Analysis solution for genome-wide association studies. The HumanHap550-Duo provides the same content as the HumanHap550 BeadChip in a dual-sample format, resulting in significantly greater throughput and lower cost per sample. Illumina makes life-science tools and integrated systems for the large-scale analysis of genetic variation and biological function.
Invitrogen (Carlsbad, California) reported the launch of a new disposable device to simplify manual passaging, the process of dividing human embryonic stem cell (hESC) colonies. The tool, Stempro EZPassage, can reduce the time required for this crucial step in stem cell research, improve the uniformity and consistency of manual passaging and decrease the amount of training required for newcomers to the field. The ability to self renew and continually divide is a main characteristic of embryonic stem cells. Cells replicate in culture, form colonies, and eventually outgrow the dish in which they were placed. Researchers must then "passage" the cells to a new dish to allow them to continue growing. Current manual and enzymatic passaging processes are labor-intensive, can take more than 20 minutes, and result in passaged colonies of non-uniform size. By contrast, the passaging process with Stempro EZ Passage can take less than a minute, and the resulting stem cell sub-colonies are uniform. In addition, unlike traditional methods, no extensive training is required for using the Stempro EZ Passage. Invitrogen is a provider of essential life science technologies for research, production and diagnostics.
IOPtima (Ramat Gan, Israel) said that it has completed development of its OT134 device, a laser-based therapy for treating glaucoma. The second-generation OT134 is based on IOPtima's laser-based technology known as LNPDS (CO₂ Laser Non-Penetrating Deep Sclerectomy) that has already been tested on 23 glaucoma patients in clinical trials. IOPtima's approach removes the risk of perforating the membrane and minimizes the risk of perforating the scleral tissue because its CO2 laser-based system is self-terminating once the desired scleral thickness has been achieved. This is possible because the CO2 laser essentially stops ablating when it comes in contact with the intra-ocular percolated liquid, which is what occurs as soon as the laser reaches the optimal residual intact layer thickness.
MedicalCV (Minneapolis) said that Crayton Pruitt, MD, a pioneer in the minimally invasive surgical (MIS) treatment of atrial fibrillation, completed the first closed-chest, beating heart cardiac ablation using the Solar surgical ablation system. The Solar received FDA clearance for the ablation or coagulation of soft tissue in March. MedicalCV makes laser-based surgical ablation systems.
Medrad (Warrendale, Pennsylvania) reported the availability of the 3.0T Prostate eCoil MR endorectal coil compatible with magnetic resonance (MR) scanners made by Philips and Siemens. Medrad introduced the 3.0T prostate eCoil for GE scanners in 2006. The eCoil conforms to the size and shape of the prostate for consistent contact between the gland and the signal-amplifying elements of the coil. The result is small field-of-view and high spatial resolution, sensitivity, and specificity that yield clearer pictures of the prostate. These pictures provide information needed by clinicians to diagnose and stage cancer, and also to plan and deliver targeted treatment, such as radiation therapy. Medrad makes imaging products.
Medtronic's Spinal Division (Memphis, Tennessee) reported the U.S. availability of the CD Horizon longitude multi-level percutaneous fixation system for use in minimally invasive spinal surgeries that require multiple levels of spinal fusion. The system's free-hand inserter and reduction screw extenders are designed to allow a stabilizing rod to be passed through a small incision over numerous levels of vertebrae in the spine. The spinal business at Medtronic specializes in advancing the treatment of spinal conditions.
Monogram Biosciences (South San Francisco, California) reported the launch of the company's latest HIV diagnostic, the Trofile co-receptor tropism assay. This launch follows the report that Pfizer has received FDA approval of novel HIV therapy, Selzentry (maraviroc) tablets. Trofile was the pivotal test used for patient selection for Selzentry's clinical development program and the two companies are engaged in a collaboration agreement to make Monogram's assay available for patient use globally. Selzentry has been approved for the combination antiretroviral treatment of adults infected with only CCR5-tropic HIV-1 who have evidence of viral replication and have HIV-1 strains resistant to multiple antiretroviral agents. Trofile Assays have been performed on more than 23,000 samples in the company's CLIA-certified laboratory. Monogram is making Trofile available to physicians immediately, so that it can be used to select patients in advance of Pfizer making Selzentry available in pharmacies.
Nymox Pharmaceutical (Hasbrouck Heights, New Jersey) reported the publication of an independent study reporting positive data on the accuracy and usefulness of the company's Saliva NicAlert test for tobacco exposure in a family practice setting. Saliva NicAlert results using saliva samples tested on-site closely matched those obtained by much more expensive and complex testing technology using urine samples sent off-site to an independent reference laboratory. Saliva NicAlert was able to correctly identify smokers who reported being nonsmokers but were ascertained to actually be smokers based on the reference laboratory liquid chromatography/mass spectroscopy results.
Oculus Innovative Sciences (Petaluma, California) held an investigator meeting to review the ongoing Phase II clinical study underway, as well as a review of potential trial design and plans for the Phase III trials. Sixteen medical centers and clinics across the U.S. are participating in the current Phase II trial, which is a randomized and open-label study to evaluate the preliminary safety and efficacy of topical Microcyn technology for the treatment of mildly infected diabetic foot infections. The primary endpoint of the trial is clinical cure or improvement of infection. Oculus is a biopharmaceutical company that makes products based upon the Microcyn Technology platform, which is intended to help prevent and treat infections in chronic and acute wounds.
Pathway Diagnostics (Malibu, California) reports the availability of SensiTrop, its molecular heteroduplex tracking assay (HTA) for determining the co-receptor tropism status of HIV infected patients. Pathway performs the SensiTrop assay in its CLIA-approved laboratory on samples received from Mayo Medical Laboratories and other soon-to-be named national laboratories. SensiTrop is a molecular based assay designed and demonstrated to be sensitive in detecting CXCR4-tropic HIV in patient samples that contain as little as 1% CXCR4. The assay is a molecular hybridization technique based on heteroduplex tracking technology. Heteroduplex tracking technology interrogates the complete HIV V3 loop, detecting sequence differences that determine whether the patient's HIV utilizes either the CXCR4 or CCR5 co-receptor. Pathway specializes in biomarker assays.
Power3 Medical Products (Houston) has concluded a 60-patient blinded validation study of its BC-SeraPro early detection blood serum breast cancer test. For the study, Power3 used its extensive patient serum sample bank to generate a statistical model that differentiates between breast cancer and control profiles. Sixty blinded patient samples were then tested against this statistical model. Twenty-two biomarkers were used to obtain the results from this study. By applying decision tree analysis, a method used to model disease and control patient demographics at the level of individual biomarkers, Power3 reported results of 97% sensitivity and 93% specificity. In addition, the company used linear discriminant Analysis, a more robust and flexible method that uses some or all biomarkers in a panel rather than individually, which achieved 80% sensitivity and 87% specificity. In addition to the BC-Sera Pro test, Power3 is currently evaluating its NuroPro early detection blood serum test for Parkinson's disease in a 500-patient validation study. Power3 is a proteomics company specializing in early detection diagnostic tests for breast cancer and neurodegenerative disease.
RemedyMD (Salt Lake City) reported the launch of OutcomeTrack, a solution that the company said allows hospitals and clinics to instantaneously support new quality improvement and pay-for-performance initiatives. OutcomeTrack has been developed in response to market demand for solutions that can easily evolve along with clinical outcome and quality reporting requirements such as Joint Commission and CMS Core Measures, the Physicians Quality Reporting Initiative (PQRI), and other pay-for-performance initiatives. OutcomeTrack allows hospitals and clinics to expand the specificity of information collected in their existing electronic medical record system. Electronically capturing required data during the patient encounter eliminates one of the major challenges for hospitals and clinics in meeting reporting requirements for compliance with quality initiatives. RemedyMd makes predictive informatics to recognize patterns, personalize treatment and measurably improve healthcare outcomes.
Restore Medical (St. Paul, Minnesota) reported the enrollment of the first patients in a clinical study evaluating the use of Pillar palatal implants in combination with continuous positive airway pressure (CPAP) therapy in the treatment of mild-to-moderate obstructive sleep apnea (OSA). This clinical study will evaluate a combined therapeutic approach of stiffening the soft palate with Pillar palatal implants, thereby allowing the reduction of CPAP pressures and potentially improving patient compliance with CPAP therapy. A CPAP machine delivers a stream of compressed air through a nasal or face mask, which keeps the upper airway open by reducing and/or preventing airway tissue collapse, and allowing unobstructed breathing during sleep. During the Pillar procedure three tiny polyester implants are placed into the soft palate. The Pillar palatal implants add structural support to and stiffen the soft palate, eliminating or minimizing the soft palate flutter or collapse that can cause or contribute to chronic snoring and obstructive sleep apnea. Restore Medical makes products to treat sleep-disordered breathing.
Rochester Medical (Stewartville, Minnesota) reported the publication of results from a clinical study which demonstrates the effectiveness of the company's proprietary infection control technology. The study, presented in the Annals of Internal Medicine concluded nitrofurazone-impregnated urinary catheters reduced the incidence of catheter-associated bacteriuria and funguria in adult trauma patients, reducing the need to change or prescribe new antimicrobial therapy. The nitrofurazone-impregnated urinary catheters used in the study were manufactured by the company. Rochester makes disposable medical catheters and devices for urological and continence care applications.
Rockwell Medical Technologies (Wixom, Michigan) said that it has begun enrollment in its Phase IIb dose-ranging study for soluble ferric pyrophosphate (SFP), a physiological iron-maintenance therapy drug. Patients will receive SFP during their normal three times/week dialysis regimen. The primary objectives of this study are to evaluate both safety and efficacy of SFP at varying dosage levels and to determine the optimal concentration of SFP that will maintain iron balance within the target hemoglobin range, in patients undergoing hemodialysis. SFP is a soluble form of iron designed to provide physiological iron-maintenance therapy in ESRD patients by delivering iron via dialysate during dialysis treatments. SFP is a stable and non-polymeric iron salt and is designed to be administered directly into the bloodstream, overcoming the need for iron release from reticuloendothelial stores in the liver and other organs. Rockwell makes specialty pharmaceuticals focused on the end-stage-renal-disease market.
Siemens Medical Solutions (Malvern, Pennsylvania) reported the release of a new version of syngo Colonography PEV (polyp enhanced viewing), an automated second reader tool for the visualization of lesions in the colon. The solution helps radiologists to detect polyp-shaped objects between 6 mm and 25 mm in size and can now be used both in clean-prepped and solid-liquid tagged protocols. With the new version, syngo Colonography PEV delivers the benefits of computer-assisted reading to a wider range of protocols commonly applied in CT colonography today, including stool tagging agents. The PEV tool is seamlessly integrated into the syngo Colonography CT application. Together with workflow-enhancing features such as auto polyp measurements, the software is designed to improve reading accuracy and efficiency. The solution was developed using a database of more than 1,700 CT colonography cases from more than 15 clinical sites worldwide, and covers a variety of CT acquisition parameters and bowel preparation protocols. Siemens Medical Solutions, a division of Siemens (Munich, Germany), provides medical technologies to the healthcare industry.
Sigma-Aldrich (St. Louis) reported the release of its new ProteoPrep 20 LC column that will simplify biomarker discovery by removing more biological "noise." With this tool, proteomic researchers will be able to delve deeper into the plasma proteome and save significant time with less fractions to assess in the analysis phase, the company said. The ProteoPrep 20 LC can accommodate a plasma or serum sample of 100 microliters and can be used to deplete a minimum of 100 samples. This effectively enables immunodepletion of more than 10,000 microliters of serum or plasma. The new liquid chromatography version of the ProteoPrep20 technology is compatible with chromatography systems and is therefore more automated. Sigma will also continue to offer the spin column formats. Sigma-Aldrich is a life science and high technology company.
Smart Products (Morgan Hill, California) recently introduced its 101 micro barbed check valve. The small valve, which fits 1/8" ID (inner diameter) tubing, is ideal for medical applications that incorporate tubing, including blood pressure cuffs, kidney dialysis, and post-surgery instrumentation - or any application where space is at a premium. The 101 micro barbed check value delivers a range of precise opening pressures that range from 2 PSI to 20 PSI. Due to the spring-loaded design, the 101 barbed check valve does not require pressure to close and can also be used as a pressure relief valve. The valve easily inserts into tubing, which eliminates potential leak points. Check valves are used in applications to restrict the ability of a fluid to flow in one direction (the check direction) while allowing fluid to flow freely in the opposite direction (flow direction). Smart Products makes check valves, pumps, and related components.
SpeechEasy (Greenville, North Carolina), a division of Janus Development Group, reported the release of the new Comfort Fit device, the fourth in the company's line of speech devices that are designed to enhance fluency in individuals who stutter. The company also claims that the device offers improved natural hearing and superior background noise reduction while featuring the most advanced technology available in fluency-enhancing devices. The new device offers lower visibility because of its small size and clear housing, and it also improves hearing by allowing natural sound to enter the ear in which the device is worn. Both ears now receive natural sound, instead of just the one that does not have a device inserted. Similar to a hearing aid, SpeechEasy is worn in or around the ear. But rather than amplify sound, SpeechEasy alters the way a user hears his/her own voice — a change in pitch and a slight delay trick the brain into hearing a second voice speaking in unison. Such "choral speech" can alleviate stuttering. The choral effect has been well documented for decades, but has only recently been scientifically recreated in a small, wireless, wearable device that can be used every day. SpeechEasy specializes in advanced fluency devices.
Synteract (San Diego) has completed implementation of version 4.5.2 of the Oracle adverse event reporting system (AERS) into its workflow process, to be used in pre- and post-marketing safety surveillance. Synteract also has registered with the FDA for electronic submission, providing its customers a more efficient and better safety reporting process. Oracle AERS is a full-featured adverse event reporting system used to collect, monitor, and manage safety data from clinical trials, post marketing studies, and spontaneous reporters, including medical information requests, product complaints and adverse event reports. This latest version of AERS offers integration with Oracle TMS, E2B (electronic to business) enhancements, local reportability, and enhanced screens for product returns and complaints. Synteract is a full-service contract research organization.
Making a leap from the paper-based medical records morass, the PatientCentral technologies team from the Texas Medical Center (Houston) introduced MyHealthArchive.com for updating, securely storing and retrieving individual patient information. Physicians and nurses can use the information to know what illnesses, medications and historical events are important to deciding what action should be taken. MyHealthArchive interfaces with hospitals using a number of electronic systems including PatientCentral's MedManager for medications and PatientCentral's DisasterLink for emergency and disaster management.
Thermage (Hayward, California) introduced its new ThermaTip STC treatment tip designed to promote substantial treatment time savings and help improve patient outcomes. The ThermaTip STC (smoothing, tightening and contouring) treatment tip is a premium version of the existing ThermaTip TC with modified temperature parameters. The STC parameters allow a greater volume of tissue to be heated, while still safely protecting the epidermis. Increased heat delivery in the dermal layer helps improve smoothing and tightening at the superficial level of the skin while maintaining Thermage's superior depth of heating to contour tissue. Thermage provides a non-invasive procedure designed to tighten and contour skin.
Varian Medical Systems (Palo Alto, California) received FDA clearance for a new high-definition multileaf collimator (MLC), an ultra-fine beam shaping device for radiosurgery. The HD120 MLC multileaf collimator helps clinicians to deliver precise radiosurgical treatments, including intensity-modulated radiosurgery, and will be included with the new Novalis Tx radiosurgery system. The Novalis Tx offers a non-invasive alternative to conventional surgery for a wide spectrum of conditions, including benign and malignant tumors, metastatic cancer, and neurological conditions like arteriovenous malformations, trigeminal neuralgia, and acoustic schwannoma. Varian makes devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, proton therapy, and brachytherapy.
World Heart (Oakland, California) reported completion of a multi-day animal study of a miniaturized, pediatric, ventricular assist device (VAD). The PediaFlow is expected to be the platform for a future minimally invasive adult VAD, intended to meet a large clinical need for earlier-stage heart failure patients. The Levacor is a bearingless, fully magnetically levitated implantable centrifugal rotary pump with clinical experience. The Levacor VAD uses magnetic levitation to fully suspend the spinning rotor, its only moving part, inside a compact housing. The levitation technology employs what the company calls a unique arrangement of magnetics expected to provide optimal system simplicity and reliability. In contrast to pumps with blood-immersed mechanical or hydrodynamic bearings, full magnetic levitation is designed to eliminate wear within the pump as well as eliminate dependence on blood properties for rotor suspension.
Xenomics (New York) reported the availability of its first diagnostic test for stratification of patients with acute myeloid leukemia (AML). The new test is based on a recent discovery of Drs. Falini and Mecucci at the Institute of Hematology at the University of Perugia (Perugia, Italy) that mutations in a nucleophosmin (NPM1) gene are characteristic of 30% to 40% of the cases of AML. NPM1 is a protein involved in regulation of ribosome biogenesis, cell division, cell death, and other important processes. Xenomics has obtained an exclusive license for the invention and developed a test that detects all 45 known mutations of NPM1 in a single reaction. The results will help physicians with prognosis, therapy, and monitoring of the disease. Stratification of AML patients is also necessary for anti-AML drug clinical trials.
X-spine Systems (San Diego) said that it had obtained FDA clearance to market its new Capless LI pedicle screw system. The system builds upon X-spine's proprietary Capless polyaxial screw locking technology by offering a more compact screw unit, increased screw angulation, screw cannulation and tissue sparing retraction. The Capless LI addresses the increasing need for reduced tissue disruption during spinal fixation procedures. It allows for several less invasive options for screw placement, including over-wire, mini-open and muscle-sparing approaches. The Capless LI is a key component of X-spine's growing lineup of products for spinal surgery. X-spine makes spinal implant systems.
Zoll Medical (Chelmsford, Massachusetts) has FDA clearance to market and sell the Zoll AED Pro with See-Thru CPR technology. This device helps minimize interruptions in CPR-one of the key recommendations of the American Heart Association guidelines for advanced cardiac life support. See-Thru CPR reduces interruptions by allowing clinicians to see organized electrical activity during CPR compressions by filtering out compression artifact (noise). This lets rescuers see a patient's underlying cardiac rhythm during resuscitation efforts and eliminates the need to stop compressions to see if defibrillation was successful. The AHA notes that a primary source of interruption of CPR is stopping to determine underlying ECG rhythm. Zoll Medical makes resuscitation devices and related software solutions.