• American Medical Systems Holdings (AMS; Minneapolis) said that it is expanding the introduction of its MiniArc single incision sling system following very promising results from initial implants with a limited number of physicians worldwide. The MiniArc system involves a single incision procedure designed to reduce operative invasiveness and enhance patient recovery. MiniArc incorporates the mesh used in other AMS slings with a delivery system for easy mesh placement without additional skin incisions required with most other sling procedures. AMS makes products to cure erectile dysfunction, benign prostatic hyperplasia, incontinence, menorrhagia, prolapse and other pelvic disorders in men and women.

• Fluidigm (South San Francisco) reported high-throughput, TaqMan reagent-based genotyping on BioMark 48.48 Dynamic Arrays, integrated fluidic circuits (IFCs) for life science research. Until now, large genotyping studies utilizing the gold-standard chemistry have typically required numerous microwell plates, dispensing robotics to handle the intensive liquid handling, and large amounts of costly reagents. BioMark dynamic arrays radically simplify the process because their matrixed network of channels, valves, and chambers automatically assembles 2,304 parallel, nano-volume reactions on each IFC. The BioMark system and dynamic arrays use PCR assays to detect specific combinations of alleles (alternative forms of genes) within individual samples. The research goal is to understand genetic variation within a large population, knowledge used in diverse fields such as cancer genetics, human genetic diversity, horticultural genetics, and wildlife conservation. Fluidigm makes systems based on the properties of integrated fluidic circuits to control fluids precisely on a nanoliter volume scale.

• Promega (Madison, Wisconsin) reports the availability of the first fully integrated personal automation system that meets regulatory requirements for clinical diagnostic DNA purification in the U.S. The Maxwell 16 system supports DNA-based tests performed by clinical labs, including sample preparation for human transplantation donor-matching tests done in HLA labs. Currently, labs can face extreme pressure in delivering test results quickly enough to act on the transplant of an organ while it is still viable. With Maxwell 16, up to 16 DNA samples can be purified simultaneously in about 30 minutes with higher yield and more consistency than similar methods. A Maxwell 16 system can be ready for work in 15 minutes from delivery, and protocols take the touch of a button to initiate. Promega provides solutions and technical support to the life sciences industry.

• Mindray Medical (Shenzhen, China) said that it has received FDA clearance for its BC-3200, an automatic three-part differential hematology analyzer, and Hypervisor VI, a central monitoring system. The BC-3200 three-part differential hematology analyzer is the first automatic diagnostic laboratory instrument introduced by Mindray targeting the North American market. The BC-3200 is designed to provide closed-tube sampling with a throughput rate of up to 60 samples per hour. The device is specifically targeted for cost-sensitive healthcare facilities and small laboratories as it delivers both more accurate test results and better overall performance than comparably priced devices. The Hypervisor VI central monitoring system allows hospitals to benefit from powerful networking and patient data review capabilities. The system can connect up to 32 bedside patient monitors and allows healthcare professionals to view and manage data from each connected monitor and the hospital's record system at a central monitoring station. Mindray Medical makes medical devices in China.

• Users of the Freedom60 infusion pump from Repro-Med Systems (Chester, New York) are now entitled to receive 20 times the Medicare reimbursement previously offered, the company said. That's the substance of notification received from the Centers for Medicare and Medicaid Services that the Freedom60 has been re-reviewed for Medicare billing. It was the determination that the Medicare HCPCS code to bill the four Durable Medical Regional Carries (DMERCs) should be: E0779 Ambulatory infusion pump, mechanical, reusable, for infusion eight hours or greater. The new coding provides for a substantial increase in reimbursement for providers using an infusion pump for authorized users under Part B of Medicare. Current approved uses under Medicare include among other things, subcutaneous immune globulin, antivirals, antifungals, and chemotherapeutics. Repro-Med Systems develops medical respiratory and infusion therapy products.

• TCN e-Systems (Newton, Massachusetts) reports a Web-based system designed to shorten the clinical study enrollment period — the longest time span in the clinical development cycle, representing the biggest opportunity for sponsors to reduce time to market. Leveraging nearly 25 years of patient recruitment experience, TCN e-Systems identifies the problem: study team members do not have access to the very data and processes they need to streamline enrollment; and solves it by introducing to sponsors the ready-to-use, e-recruitment toolkits that comprise a patient recruitment management system (PRMS). Unlike its heavy-duty predecessors in the clinical data management technology space, clinical trial management systems (CTMS) and clinical data management systems (CDMS), TCN e-Systems' PRMS solution is Web-based, can be deployed rapidly and cost-effectively, and requires little to no training. TCN e-systems makes e-recruitment toolkits for clinical trials.