• Biomet (Warsaw, Indiana), a manufacturer of products used primarily by musculoskeletal medical specialists in both surgical and non-surgical therapy, reported that the FDA has issued regulatory clearance for the company's Regenerex Porous Titanium Construct acetabular system for primary and revision hip surgery. Regenerex Porous Titanium Construct is a highly porous structural material engineered for optimal biological fixation. The system includes acetabular shells and augments designed to address complex revision procedures. The product launch is scheduled to begin during the first half of FY 2007.

• Biophan Technologies (Rochester, New York), a developer of next-generation medical technology, said that it has filed a U.S. patent application for the use of halloysite nanotubes for controlled release of drugs. The technology uses halloysite nanotubes, which are being commercialized by NaturalNano (Rochester, New York). The nanotubes, which are hollow inorganic nanostructures derived from clay, allow the linear, controlled release of drugs. In addition, the nano-chopping technology being developed allows for achieving precisely defined sizes of nanotubes to ensure the predictable performance and dosing required for a given drug, Biophan said. The technology covered in Biophan's new patent complements NaturalNano's technology for the extraction, separation, and classification of halloysite nanotubes to the high-precision levels needed by the pharmaceutical industry, NaturalNano said.

• Cybernet Medical (Ann Arbor, Michigan), a developer of telemedicine technology for outpatient care, reported the release of a telemonitoring solution for its web-based electronic patient record system, MedStar. MedStar users can now offer patients who browse the web a fully functional version of the MedStar without in-home patient hardware. MedStar offers full vital signs data acquisition, AI-powered question-and-answer logic that can be delivered via the web or by interactive voice response, and two-way IP phone and video service between the patient and caregiver. The patient only needs a browser-enabled PC, Internet service and a broadband connection for two-way video service. A special version of the MedStar data hub is optionally available to connect physiological measurement devices to the user's PC for automated data upload. The product will be released at the American Telemedicine Association 2006 trade show, which began Sunday in San Diego.

• Diomed Holdings (Andover, Massachusetts), which is developing minimally invasive medical technologies, reported the market introduction of the VeinViewer Imaging System for use in sclerotherapy, phlebectomy and varicose vein treatment. The VeinViewer, manufactured by Luminetx (Memphis, Tennessee) and cleared by the FDA in 2004, is a biomedical imaging system which utilizes near-infrared light to illuminate, on a real-time basis, subcutaneous veins to an average depth of 8 mm and projects their location on the surface of the skin with an accuracy of 0.06 mm. VeinViewer is a unique guidance tool allowing physicians to visualize the exact location and orientation of the patient's veins, thereby providing more precise sclerotherapy and phlebectomy procedures through increased accuracy in vein targeting. Unlike other methods of targeting veins, this hands-free technology uses harmless near-infrared light to increase physician effectiveness and decrease the amount of time to locate a vein. Diomed said it plans to display the VeinViewer at the Society of Vascular Surgery annual meeting in Philadelphia in June.

• Eklin Medical Systems (Santa Clara, California), a provider of veterinary PACS, Practice Information Management (PIMS) software and digital radiography products, said it has added two new options to its RapidView diagnostic workstation product line. The new additions include the RapidView 2GSi, for detailed radiographic studies, and the RapidView SD-1C, designed especially for client education. The Eklin RapidStudy DR system provides the veterinarian with a radiographic image that can be viewed immediately on a high-resolution monitor without need for film developing. The Eklin DR system also offers sophisticated image processing tools. Eklin offers either a 9”x11” sensor panel or a full- size 14”x17” sensor panel. Images can be stored and archived for future evaluation using the Eklin PACS, which is based on DICOM standards. In addition, medical records, lab results, billing, financial statements and other pertinent patient or practice information are available with Eklin's VIA PIMS.

• Guardian Healthcare Systems (Herndon, Virginia), a division of Guardian Technologies International, reported the release of FlowPoint 6.1, an integrated, web-based radiology information system (RIS) and picture archiving communications system (PACS) that enables healthcare enterprises to combine patient medical data and radiology images into one digital record. FlowPoint 6.1 includes an optional module for report dictation using the Dragon NaturallySpeaking SDK software developers toolkit from Nuance Communications (Silver Spring, Maryland). FlowPoint 6.1 also includes digital voice-recording capability integrated with the voice-recognition system. FlowPoint 6.1 includes additional updates and enhancements, including a larger label printing library of templates; extended international language vocabularies; an updated set of Crystal Reports, which address referring physician exam volumes and modality analysis reporting; an enhanced scheduling and calendar module that displays more patient exam information, enabling quicker access to important information; the ability to share information with an unlimited number of referring physicians; and enhanced search tools.

• Ingenious Med (Atlanta), a provider of inpatient practice management solutions, reported the release of IM Practice Manager, a consolidated rounding, charge capture, and business intelligence reporting platform. Ingenious Med showcased IM Practice Manager last week at the Society for Hospital Medicine conference in Washington. IM Practice Manager features a wireless, Internet-based rounding platform that can be used with PDAs, tablet PCs or desktop computers to help physicians gather information and capture charges during hospital rounds; charge capture with dual-tier validation via CodeCorrect and IM CodeCheck; business intelligence management reporting that improves physician and practice performance; communication tools that facilitate and improve inter-staff communication while optimizing patient handoff/transition and fulfilling JCAHO requirements for electronic sign out and peer-to-peer communication; IM Bill Manager back-office charge management that reduces accounts receivable days; clinical tools for e-prescribing, quality and core measure enhancement and admission-discharge components; IM Practice Plus package that includes advanced reporting, streamlines practice operations and enables physician scheduling; IM Xchange data interface allowing integration with hospital information systems, billing systems, EMR and other third-party applications; and IM MasterCoder E&M coding and documentation tool.

• Kyphon (Sunnyvale, California) reported that it has expanded its intellectual property coverage over kyphoplasty, the minimally invasive procedure for treating spinal fractures caused by osteoporosis or cancer that Kyphon pioneered in the late 1990s, with issuance of U.S. patent No. 6,981,981, a method patent covering various aspects of performing the procedure. The patent discloses and claims, among its various embodiments, a method concerning introducing an expandable device into a vertebral body, expanding the device to selectively compact a region of cancellous bone inside the vertebra, and then filling the compacted region.

• Lipid Sciences (Pleasanton, California) reported that the company had received notification from the institutional review board of MedStar Research Institute that approval had been given to begin a human clinical trial of Lipid Sciences' Plasma Delipidation System-2 (PDS-2). The human clinical trial, to be conducted at the Washington Hospital Center (Washington), will enroll 30 patients with angiographic evidence of coronary artery disease in the target artery. The primary endpoint for this trial is clinical safety and feasibility in the targeted patient population. PDS-2 is designed to selectively remove cholesterol from the high-density lipoprotein particle in human plasma. The investigational device is composed of an automated processor, sterile single-use disposable kit, and reagents. The PDS-2 device is not connected to the subject at any time. The treatment subjects' plasma is processed offline with Lipid Sciences' LSI-S955 proprietary reagent mixture, pumped into a transfer pack, and then re-infused back into the subject via a separate infusion pump after processing. All subjects in the trial are monitored before and throughout the process. Lipid Sciences is a development-stage biotechnology company engaged in the research and development of products and processes intended to treat major medical indications, in which lipids play a key role.

• MTSI (Brea, California), an IT and business solutions provider, reported a solution partner agreement with IFS (Schaumburg, Illinois), a global business applications supplier of enterprise software for mid-market and large enterprises, to introduce a software suite of products to the North American medical device industry. Designed to improve efficiency, control and compliance of day-to-day operations, SLiM (Service Lifecycle Manager) is powered by IFS Applications, the component-based enterprise software suite that provides the core foundation of the solution. SLiM is the first fully integrated service management system to combine quality and service best practices through the capture of all relevant data to track a product from conception to obsolescence.

• NMT Medical (Boston) reported that results from its BEST (BioStar Evaluation STudy) trial are scheduled to be presented at the Late-Breaking Clinical Trials session at the EuroPCR meeting on May 16 in Paris, France. BEST is a multicenter study, which is evaluating the company's new bioabsorbable collagen matrix technology, designed to promote biological closure of structural heart defects such as PFO (patent foramen ovale). The BioStar implant is delivered through a minimally invasive, catheter-based procedure. Approximately 60 patients were enrolled in the BEST study and were followed for six months. The study was designed to gain European commercial approval for BioStar through the CE mark process. Approval is currently expected by year-end 2006.

• OcuSense (San Diego), a developer of doctor's office-based tests for eye care, has received notice from the U.S. Patent and Trademark Office of issuance of a core patent, No. 7,017,394. “Tear Film Osmometry” claims a lab-on-a-chip approach to measure tear osmolarity for the diagnosis and management of Dry Eye Syndrome. The patent covers the use of microelectronic sensors that can reliably detect osmolarity in small fluid volumes. OcuSense embeds its sensors into proprietary, microfluidic lab cards that then rapidly process the tear samples without the risk of evaporation. The entire test is expected to take only two minutes to perform, and helps the eye care practitioner more accurately prescribe appropriate treatment or ensure a better contact lens fit.

• Planar Systems (Beaverton, Oregon), a manufacturer of flat-panel display systems, said it has selected ATI Technologies (Markham, Ontario), a manufacturer of 3-D graphics, PC platform technologies and digital media silicon solutions, to provide advanced graphics processing technology for its medical imaging products. Planar's Dome AX4 is built with the new ATI FireGL V3400, a commercially-available workstation graphics board created to accelerate the speed at which users can load, review, report and communicate patient cases with colleagues. With the integration of the ATI FireGL V3400, Planar's Dome EX series, designed for applications in radiology, cardiology, nuclear medicine, positron emission tomography/computed tomography, MRI, ultrasound, dermatology and the operating room, allows users to experience enhanced visualization of various color modalities, 2-D color imaging, image fusion and 3-D imaging with faster delivery and image processing. In addition, the introduction of the Dome AX4 is enabling the integration of 3-D volumetric rendering and texturing, which require the use of Open GL or DirectX acceleration, into picture archiving and communications systems. ATI FireGL V3400 graphics controller boards will be offered with Planar's Dome series E2, E2c, E3, E3c and E4c, as well as the P1 Bundle and P2 Bundle.

• Power3 Medical Products (The Woodlands, Texas), a proteomics company that develops early detection diagnostic tests for cancer and neurodegenerative diseases, said it has filed an application for a patent with the U.S. Patent and Trademark Office. Initially filed on a provisional basis in May 2005, the application is for Power3's first generic, blood-based diagnostic test for neuromuscular disorders, including Amyotropic Lateral Sclerosis and Parkinson's disease. The application was filed in conjunction with major research institutions in the Houston area, with Power3 having an exclusive license to commercialize the technology involved. The application is for a test which uses a blood sample, separates the proteins present, analyzes a panel of protein biomarkers using proteomic techniques, and then determines whether or not the patient has a neuromuscular disease based on the quantity of the biomarkers in the sample combined with biostitistical analysis. Power3 also said it intends to extend the technology to high throughput immunodiagnostics suitable for clinical laboratories and doctors' offices.

• ReGen Biologics (Franklin Lakes, New Jersey), an orthopedic products company, said an article in the April issue of The Journal of Bone and Joint Surgery provides scientific validity for two important measures of patient status post-meniscus surgery. ReGen said it has conducted the largest clinical trial on the meniscus, the CMI multicenter clinical trial, and has the largest longitudinal database involving the meniscus and the effects of arthroscopic surgery on the meniscus. The clinical trial highlights the role played by functional and activity scores that measure performance of the meniscus. The authors demonstrated the validity, reliability, and responsiveness of the Lysholm Knee Score and Tegner Activity Scale, which are important in measuring the meniscus performance and are necessary to determine the value of certain procedures or products such as the ReGen CMI. Publication of these findings confirms the appropriateness of the ReGen trial design and provides support that the clinical benefit of a product such as the CMI can be measured, the company said.

• WaveLight (Sterling, Virginia) said that it has received FDA approval to treat mixed astigmatism with the wavefront-optimized Allegretto Waveexcimer laser system. The indication includes the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 diopters at the spectacle plane. The Allegretto Wave is a wavefront-optimized excimer laser that delivers specific ablation profiles based on each eye's unique corneal asphericity. The wavefront-optimized algorithm is applied to all Allegretto Wave treatments, including mixed astigmatism.