A new non-invasive system for general lung function monitoring has received FDA clearance. The system, called Vibration Response Imaging (VRI) was developed by Deep Breeze (Or-Akiva, Israel), founded in 2001 by Igal Kushnir, MD. Michael Beck, U.S. manager for Deep Breeze, told Biomedical Business & Technology that Kushnir based his invention for functional imaging of lungs on the concept of sensing vibrations and then chose the company's name based on a key feature of its primary product. Beckl said Kushnir thought the concept of noninvasive lung function monitoring without radiation was "a breath of fresh air" for the industry

"The FDA has approved us for the monitoring of lung sounds," Beck told BB&T. "We are basically taking the vibrations that come from an individual's lungs, and through sophisticated algorithms turn that into a functional image of the lung." VRI is not approved for now, at least for diagnosis of specific lung disorders.

Beck said VRI technology records lung sounds from sensors applied to a patient's back while he or she breathes. The system then uses an algorithm to convert the data into images on a computer screen. Changes in tissue composition or alteration in airflow impact how sounds within the lungs vibrate, and subsequently how the images, dubbed VRIXP, appear on the system's computer screen.

Deep Breeze says that the VRIXP procedure "takes only minutes" in a physician's office and because it does not use radiation, it can be used repeatedly for continuous monitoring, without downstream side effects. For example, it could be used in patients who have "already been diagnosed with a different modality, whether it's XR, CT or MR."

"This is a very simply, very easy, very quick technique, without radiation, to give a physician or healthcare professional a view of what's going on in the patient's lungs," Beck told BB&T. And he said that while the device is new, the basic approach it employs is not. "Lung sounds have been looked at for years and years and years, usually in a graphical form."

Deep Breeze is not aware of any competitors to its device. Graphical devices have previously received approval from the FDA, but not a device that produces an actual functional image, according to Beck.

The company received a CE mark in 2005 to use its VRI device for diagnostics purposes and has marketed the system in Europe since the summer of 2006. It has a direct marketing operation in Germany targeting pulmonary interventionalists at both "reference sites and installed bases" in that country, Beck said. It has distributor operations in Italy, Spain and Greece.

The company also recently secured regulatory approvals to market the system in Korea, where it also has a distributor operation. In Korea, the system is being used by pulmonologists. And because "preventative medicine is big in Asia," and "very, very big in Korea," the device is being used widely as a screening tool, Beck said.

Regulatory approval is expected by the company in China this month, and it has four sites there for final clinical trials of the device.

With FDA clearance for the U.S. market in its pocket, Deep Breeze plans to launch VRIXP in the U.S. at the 2007 CHEST meeting Oct. 20-25 in Chicago. Following the introduction at CHEST, product education will be a major component of the company's marketing efforts, Beck said, noting that this should be easily done. There have been "hands-on exhibitions" of the device at various trial sites, but the procedure for administering the test can be taught "in 10 minutes," he said.

And while Deep Breeze sells the device for between $35,000 and $45,000, in U.S. dollars abroad, the company has not yet determined a price for the U.S. market. Going forward in the U.S., the company is conducting trials, for example, at M.D. Anderson Cancer Center (Houston), where the objective is to "look at different types of cancers and vibration response imaging and how it relates to other types of imaging modalities." In another trial at a New Jersey trauma center and intensive care unit, the device has been used with patients on ventilators.

Elsewhere in the product pipeline:

• Abbott (Des Plaines, Illinois) reported receiving a supplemental premarket approval from the FDA for its recently introduced RealTime HIV-1 viral load test. The approval allows Abbott to market a number of enhancements to the test, including a new 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 (Rockville, Maryland). The company says that 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. The assay has a broad range, capable of quantitating HIV-1 in plasma down to as few as 40 RNA copies per mL, surpassing the standard of care in diagnostic sensitivity of 50 copies per mL. The test targets the highly conserved pol integrase region of the HIV-1 genome, so that the test has ability to detect and measure all known genetic variations of the virus.
• Advanced BioHealing (La Jolla, California) released an analysis that it said demonstrates the value of serial debridement in treating lower extremity wounds. The study, titled "Serial Surgical Debridement Increases the Healing Rates of Chronic Lower Extremity Wounds," was presented at the annual meeting of the American Podiatric Medical Association (Bethesda, Maryland) in Philadelphia. Data from the clinical trials revealed that wounds serially debrided within the first four weeks of the treatment period had a median wound area reduction 54% higher than wounds that were not debrided. Additionally, venous leg ulcers receiving debridement at more than half of their study visits in the first month had a better chance of reaching 75% wound closure in four weeks, 90% wound closure in 12 weeks, and/or 100% closure in 12 weeks. Diabetic foot ulcers receiving debridement at every study visit over 12 weeks had a much greater chance of reaching ultimate wound closure than those debrided less often. Advanced BioHealing specializes in regenerative medicine.
• AHA Solutions, a subsidiary of the American Hospital Association (AHA; Chicago), reported its endorsement of the Wi-Fi based Active RFID (radio frequency identification) tracking system from AeroScout (Redwood City, California), which helps hospitals track and manage the location, movement and status of patients, caregivers and vital hospital equipment, allowing hospitals to improve patient care and patient experience as well as reduce costs. AHA Solutions identified tracking systems as an integral element of a new platform of products and services geared to improve operational efficiencies related to patient flow and patient centered care. AeroScout was chosen for endorsement by AHA Solutions after an extensive review and market analysis of the vendors and technologies for RFID and location tracking. AeroScout is a provider of active RFID asset tracking and location solutions over standard Wi-Fi networks.
• Angiotech Pharmaceuticals (Vancouver) reported FDA clearance for a new polymer line of absorbable sutures, broadening the offering of the Quill self-retaining system (SRS) product line. Angiotech is launching Monoderm, a new line of Quill SRS sutures made from a rapidly resorbing polymer, intended primarily for superficial wound closure. The sutures will be available in three different diameters. A patented helical barbed design enables surgeons to suture without the use of knots. The absence of knots provides a wide range of clinical and economic benefits, including: potential to improve patient outcomes, potential to save time in the operating room, and enhanced procedural techniques. Angiotech is a medical device and specialty pharmaceutical company.
• Atrium Medical (Hudson, New Hampshire) reported the availability of its di-2-ethylhexyl phthalate- (DEHP) free thoracic catheters. The company said DEHP-free catheters are its in a series of medical device innovations engineered 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, a new product offering in its regional anesthesia line. The pen is a non-invasive percutaneous nerve mapping device designed to help those administering peripheral nerve blocks quickly locate superficial nerves and identify the best 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.
• BodyMedia (Pittsburgh) said it has begun shipping SenseWear WMS (weight management solution) to its customers. The company said that SenseWear WMS is the first web-based clinical weight management solution to focus on behavior therapy and designed to improve weight loss outcomes by increasing patient adherence to behavior prescriptions. The system is intended to promote lifestyle changes for weight loss by enabling health practitioners and their patients to continuously 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.
• 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 commercial launch. The new MC suite is an upgrade in MC processing 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 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) said it has launched 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 better 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 provides technologies enabling researchers in the life sciences to create life-saving and enhancing medicines and diagnostic tests more quickly and efficiently.
• Clinical Solutions (Basingstoke, England) reported the launch of new software, named Bio Surveillance, for early detection and management of a pandemic outbreak. Bio Surveillance provides a series of algorithms enabling 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 to steer clinicians through the healthcare delivery process so that patients are referred to the most appropriate level of care. The system was trialed during Exercise Cumpston, Australia's largest 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 for healthcare.
• 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.
• ConvaTec (Skillman, New Jersey) reported the U.S. availability of the ConvaTec moldable technology line of ostomy skin barriers, designed to offer improved protection of the skin surrounding the stoma. The skin barriers are available on the company's SUR-FIT Natura ostomy system. The company said that according to a study of more than 200 people living with an ostomy, 45% of such patients suffer from a peristomal skin disorder, of which 77% could be related to contact with stoma effluent. A close-fitting skin barrier reduces the chance of waste coming into contact with the skin, which may result in skin breakdown. Traditional ostomy barriers allow for gaps which can compromise skin protection. The design of ConvaTec skin barriers allows for a snug fit across a wide variety of stoma shapes and sizes. The elastic materials of the adhesive allow the barrier to gently expand and contract along with the stoma as it changes size throughout the day. ConvaTec makes ostomy and wound care products.
• Cook Medical (Bloomington, Indiana), a manufacturer of interventional devices, said it has submitted the final module of its pre-market application (PMA) to the FDA for the Cook Zenith TX2 thoracic aortic aneurysm (TAA) endovascular graft. Cook said that the PMA submission includes safety and efficacy data on about 230 patients who have been treated with the Zenith TX2 in clinical trials. TAAs 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.
• Corgenix Medical (Denver) has submitted a 510(k) notification to the FDA for the company's IgG Anti-AtherOx test kit, a laboratory test kit that uses the company's AtherOx technology to detect IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with ₂-glycoprotein I ( ₂GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). The AtherOx technology uses oxLDL complexed with the plasma protein ₂GPI. Although oxLDL has been implicated in cardiovascular disease, clinical data demonstrates that the determination of oxLDL/ ₂GPI 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.
• Covidien (St. Louis) reported the availability of several enhancements for its MRidium MRI infusion system a non-magnetic IV infusion pump. Specifically designed to address the challenges of the MRI suite, the pump has added features that help operators administer intravenous medication more efficiently. The MRidium includes a library of drugs commonly initiated in the MRI suite, along with an integrated dose rate calculator to aid in accurate and efficient dispensing of medication. Additionally, the MRidium features a wireless remote control that enables medical professionals to operate the system from the control room. The pump also includes a microbore vented syringe infusion set that allows drug flow from the syringe into the IV tubing for accurate drug delivery while minimizing waste. Covidien makes surgical devices, energy-based devices, respiratory and monitoring solutions, patient care and safety products.
• Study results recently published in the Journal of Academic Radiology indicate that breast-specific gamma imaging (BSGI) provides higher sensitivity for the detection of ductal carcinoma in situ (DCIS) than mammography or MRI and can reliably detect small, sub-centimeter lesions. The study evaluated the technology on women with mammographically suspicious microcalicifications and other high risk factors. BSGI was performed with the Dilon Technologies' (Newport News, Virginia]) Dilon 6800, a molecular breast imaging technique that can see lesions independent of tissue density and discover very early stage cancers. BSGI serves as a complementary diagnostic adjunct procedure to mammography and ultrasound for difficult-to-diagnose patients. With BSGI, the patient receives a radioactive tracing agent that is absorbed by all the cells in the body. Cancerous cells in the breast, due to their increased rate of metabolic activity, absorb a greater amount of the tracing agent than normal, healthy cells and generally appear as "hot spots" on the BSGI image. BSGI is ideal for patients with mammograms that are difficult to interpret due to a variety of factors, such as: dense breast tissue, suspicious areas on a mammogram, lumps that can be felt but not seen with mammography or ultrasound, implants and breast augmentation, scarring from previous surgeries and for women with a strong positive family history of breast cancer.
• DJO (San Diego) said that it has received FDA approval for a supplement to the company's existing pre-market application approval (a PMA-S). The PMA-S covers several new product features built into the control modules for its combined magnetic field (CMF) OL1000 and SpinaLogic bone growth stimulation product lines to improve ease of use. DJO says that CMF OL1000 and SpinaLogic devices are the only bone growth stimulation devices using CMF technology. "CMF is the only waveform clinically proven to stimulate bone growth from a simple 30 minute per day treatment with FDA-indicated use in both long bone and primary lumbar spine applications, the company said," DJO said. The CMF OL1000 and OL1000SC devices are indicated for non-invasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A non-union is considered to be established when a fracture site shows no visibly progressive signs of healing.
• ELA Medical (Denver), a Sorin Group (Milan, Italy) company, reported the first U.S. implant in an observational study, titled NATURE, that will enroll 1,440 patients in North America and Europe. The objective of NATURE is to observe the evolution of atrio-ventricular conduction disorders in pacemaker patients over a two-year time period. Patients implanted with either ELA/Sorin 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 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 manufacturing implantable pacemakers and defibrillators.
• HydroCision (Billerica, Massachusetts) reported the launch of the SpineJet EndoResector for endoscopic minimally invasive discectomy, based on HydroCision's HydroDiscectomy platform. HydroDiscectomy uses a high-velocity fluidjet to quickly and safely decompress herniated discs, providing relief to patients suffering from chronic back and/or leg pain. The SpineJet is used in conjunction with commercially available spine endoscope imaging systems to perform a HydroDiscectomy procedure. This minimally invasive procedure allows surgeons to directly visualize and image the spine disc through a small surgical incision. This same-day procedure is usually performed in an outpatient setting allowing the patient almost immediate relief of leg pain caused by a pinched nerve in the back. HydroCision makes fluidjet-based surgical tools.
• 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, according to the company. Illumina makes life science tools and integrated systems for the large-scale analysis of genetic variation and biological function.
• Innovative Spinal Technologies (IST; Mansfield, Massachusetts) reported commercial launch in the U.S. of the Paramount VBR system for minimally invasive spine surgery. The design of the Paramount VBR offers control and maneuverability for precise implant placement. The comprehensive instrumentation system, combined with a broad selection of bulleted, anatomically correct PEEK-OPTIMA implants, delivers intraoperative versatility and performance at all lumbar levels of the spine. IST makes motion preservation and minimally invasive treatments for spinal disorder.
• 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.
• Lumen Biomedical (Plymouth, Minnesota) reported FDA clearance to market two additional sizes of its Xtract aspiration catheter in the U.S. The Xtract, which is indicated for use in the removal of soft, fresh thrombi (clots) and emboli from arteries in the body, is now available in two larger sizes (5 Fr and 5.8 Fr). The smaller catheter size (4.2Fr) was granted FDA clearance June 2006. Clots can restrict or interrupt blood flow within an artery, creating severe complications in patients. Thromboses events can be caused by physiological conditions or from interventional procedures themselves, one such complication being stent thrombosis. The Xtract is designed to remove fresh, soft emboli or thrombi from the arterial system. It is a single-use, 0.014" guidewire compatible, temporary intravascular extraction and aspiration catheter system. The catheter features a braided shaft for responsive delivery and kink resistance, a large aspiration lumen, and a soft curved tip to negotiate obstructions and provide directional suction. Lumen says that it makes products designed to be used in any anatomical area where embolic protection or emboli removal is required.
• MedPlexus (Sunnyvale, California) reported the availability of its Software-as-a-Service (SaaS) suite of solutions, which include practice management software, electronic health records (EHRs) and a browser-based patient self-service portal. The solution also includes SaaS-enabled services for billing, front-office call management, and practice audit and accounting services. Under the SaaS model, MedPlexus hosts the applications and manages the maintenance, software upgrades and disaster recovery, thus, it said, minimizing the risks and costs incurred by the physician practice and/or healthcare organization while allowing physicians to return to the realm of providing care as opposed to managing technology solutions. MedPlexus makes internet-based administrative, financial and clinical software and services for physician practices.
• Neuromonics (Bethlehem, Pennsylvania) reported the initiation of the first post-market U.S. study to evaluate long-term outcomes for its neuromonics tinnitus treatment. This FDA-cleared therapy is designed to interact, interrupt and desensitize tinnitus disturbance for long-term benefit. The neuromonics tinnitus treatment addresses the neurological, psychological and audiological basis of tinnitus. Neuromonics' device is customized to the patient's unique hearing and tinnitus profile. It delivers a customized neural stimulus that promotes neural plastic changes, allowing the brain to filter and process the tinnitus. The delivery system, to carry the neural stimulus, consists of spectrally modified customized music which engages the brain's emotional response center, the limbic system. Neuromonics makes medical devices designed for long-term relief of tinnitus.
• 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.
• Siemens Medical Solutions (SMS; 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 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.
• SMS also reported that it has added the ImageGrid archive appliance from Candelis (Irvine, California) to its accessory solutions product portfolio. The fully integrated multimodality storage drive is offered through Siemens' global sales and distribution channels. The ImageGrid is fully compliant with DICOM (Digital Imaging and Communications in Medicine) standards. It provides healthcare facilities a scalable storage solution to accommodate the increasingly larger volumes of data and images generated by medical imaging modalities, such as mammography, computed tomography, molecular imaging and ultrasound. Candelis is a medical informatics company. SMS, a division of Siemens (Munich, Germany), develops medical technologies for healthcare.
• Sigma-Aldrich (St. Louis) reported the release of its new ProteoPrep 20 LC column that will simplify biomarker discovery by removing more biological "noise." The device is designed to enable proteomic researchers to delve into the plasma proteome and save 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) has 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.
• The Orthopaedic Reconstruction (Memphis, Tennessee) business of Smith & Newphew (London) reported FDA clearance of its Journey bi-cruciate stabilized (BCS) knee system, the Genesis II total knee system and the Legion revision knee system product lines for gender specific requirements. The asymmetric design of the tibial baseplates used in the system ensures an anatomically accurate fit of the tibial baseplate component to the proximal tibia for male and female components. The design features of the Journey provide function for both the anterior cruciate ligament and the posterior cruciate ligament and result in improved stability and motion in both males and females. The Legion is designed for revision surgery. These systems feature S&N's Oxinium technology, a bearing product technology created through a manufacturing process that transforms the surface to a ceramic, resulting in a material that incorporates features of ceramic and metal while avoiding the limitations associated with either material, according to the company.
• 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 contract research organization.
• TeleTracking Technologies (Pittsburgh) will automate patient flow at New York City's Montefiore Medical Center as part of an initiative to accommodate expected patient increases when several surrounding health facilities close. The 1,122-bed health system will adopt a suite of TeleTracking solutions designed to manage existing bed capacity more efficiently and avert hospital overcrowding. Already among the nation's busiest emergency care providers, Montefiore annually serves more than 65,000 inpatients and nearly 2 million outpatients in the Bronx and Westchester County. TeleTracking is a healthcare software firm which provides software and process redesign services that create prompts, feedback and data flow to make real-time capacity management possible.
• The PatientCentral technologies team from the Texas Medical Center (Houston) has 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) has introduced the ThermaTip STC treatment tip designed to promote 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 depth of heating to contour tissue. Thermage provides a non-invasive procedure designed to tighten and contour skin.
• Varian Medical (Palo Alto, California) reported receiving FDA clearance for a "smart" radiotherapy treatment planning tool that it said will enable clinicians to significantly reduce the amount of time needed to plan advanced treatments, including intensity-modulated radiation therapy and image-guided radiation therapy. The new smart segmentation feature, which has been added to Varian's Eclipse treatment planning product, is the world's first fully automatic tool that uses intelligent software to identify and outline organs and other structures within diagnostic images of the thorax and male pelvis. Up to now, identifying structures to be irradiated or protected during radiotherapy treatments had to be done by hand. The smart segmentation tool can automatically identify all of the structures of interest in less than 45 seconds. Clinicians can now start the planning process with images that have important anatomical structures already outlined, and simply adjust them according to their clinical judgment. Varian makes medical technology for treating cancer and other medical conditions with radiotherapy, brachytherapy, and radiosurgery.
• VeriChip (Delray Beach, Florida) reported the launch of its "Patient First" program. Under this program, patients receive the VeriMed microchip with no up-front cost with a subscription to the VeriMed patient registry. Besides not requiring an upfront cost, the Patient First model enables patients to access the VeriMed patient identification system for a "nominal" monthly subscription. The VeriMed system uses an implantable RFID microchip in combination with a handheld RFID scanner and a secure patient database, provides immediate access to health information for patients who arrive at an emergency department unable to communicate. VeriChip makes radio frequency identification systems for healthcare and patient-related needs.
• Vermillion (Fremont, California) reported the publication of research that details how a protein biomarker called beta-2 microglobulin may aid in the diagnosis of peripheral artery disease (PAD). The findings, which suggest beta-2 microglobulin is elevated in patients with PAD and that the level of the protein is correlated with the severity of the disease, will be published in the September issue of Circulation. Vermillion said it intends to develop a blood test for the diagnosis of PAD, and that its development program is aimed at commercializing a panel of new biomarkers, which includes the newly discovered role of beta-2 microglobulin. Beta-2 microglobulin levels were correlated with the severity of disease, as determined by ankle blood pressures, and by the distance patients could walk on a treadmill. Beta 2 microglobulin was an independent predictor, even after taking into consideration traditional risk factors such as cholesterol, diabetes and age. Vermillion makes diagnostic programs in oncology/hematology, cardiology and women's health with initial focus on ovarian cancer.
• VivoMetrics (Ventura, California) said that it has made enhancements to its LifeShirt preclinical system by incorporating Bluetooth wireless technology. The upgraded capabilities of the wireless technology deliver fast connections between the LifeShirt and data management systems that measure and quantify the research subject's vital signs. Designed for the needs of the preclinical market, the system includes a lightweight, machine washable garment with embedded sensors that collect pulmonary, cardiac, posture and activity signals from freely moving subjects for up to 24 hours. Data generated is wirelessly transmitted and VivoSoftware allows researchers to monitor and analyze data of up to 16 subjects in real-time or to be stored for later analysis. VivoMetrics is a developer if non-invasive products and services.
• Vyteris (Fair Lawn, New Jersey) reported the commercial availability of LidoSite to the 40 million American patients in physician offices who are needle-averse or even needle-phobic. The company says that . LidoSite is the first active transdermal patch approved by the FDA to deal with pain associated with blood draws (venipuncture) IV (intravenous) cannulations and laser ablation of superficial skin lesions. The device uses iontophoresis to carry a combination of the local anesthetic lidocaine and vasoconstrictor epinephrine, which localizes the anesthetic effect, from a patch through the skin layer and into the underlying tissue by way of a mild electrical current. LidoSite is composed of a heart-shaped controller that houses a microprocessor regulating dosing of medication, intervals and duration of dosing and is good for up to 99 patch applications, according to the company.
• Wright Medical Group (Arlington, Tennessee) reported U.S. and international release of Pro-Dense Injectable Regenerative Graft, a new bone graft substitute that it said has demonstrated unique and highly favorable metaphyseal bone healing properties compared to autograft in preclinical studies. A composite of calcium phosphate and sulfate, Pro-Dense uses a tri-phasic resorption profile providing the biologic environment to allow the body to quickly and reliably regenerate dense new bone. Extensive animal testing found that new bone regenerated by Pro-Dense was of greater density and greater compressive strength at 13 weeks than the new bone regenerated by autograft, which is widely considered to be the "gold standard" for bone grafting. Additionally, the testing revealed that the bone voids treated with Pro-Dense Graft formed new bone at a faster rate than autograft.
• Xenomics (New York) reported availability of its first diagnostic test for stratification of patients with acute myeloid leukemia (AML), the most common form of acute leukemia with about 13,400 new cases expected in 2007 in the U.S. 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. Xenomics makes next-generation medical diagnostic technologies.
• Zoll Medical (Chelmsford, Massachusetts) has FDA clearance for the Zoll AED Pro with See-Thru CPR technology. The company says that the device helps minimize interruptions in CPR, a key recommendation from the American Heart Association (AHA; Dallas) 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), letting rescuers see underlying cardiac rhythm during resuscitation and eliminating the need to stop compressions to see if defibrillation was successful. Zoll says that AHA notes that a primary source of interruption of CPR is stopping to determine underlying ECG rhythm.