• BodyMedia (Pittsburgh, Pennsylvania) said it has released version 6.1 of the SenseWear software for its clinical customers and their patients. The SenseWear 6.1 software is compatible with the SenseWear wearable display device and has improved algorithms that report accurate metabolic metrics. This solution enables patients to keep track of their health data such as calories burned, physical activity, and sleep so health professionals can objectively monitor adherence to their behavioral prescriptions. Patients and their physicians use SenseWear to identify the behaviors that best promote increased activity, weight loss, and healthy living - ultimately lowering the risks associated with their chronic conditions. BodyMedia specializes in metabolic assessment and behavioral therapy solutions.
• eResearchTechnology (Philadelphia) reported that it is launching a new line of business focused on electronic patient reported outcomes (ePRO). This business will initially concentrate on the central nervous system therapeutic area. The company has entered into a long-term strategic relationship with Healthcare Technology Systems (HTS; Madison, Wisconsin), a company specializing in the research, development and validation of computer administered clinical rating instruments. The relationship includes the exclusive licensing (subject to one pre-existing license agreement) of 57 interactive voice response (IVR) cognitive function assessments offered by HTS, along with HTS’ IVR system. As part of its relationship with HTS, eRT will have rights to future products developed by HTS for use in Phase I-IV clinical trials and in other areas of clinical research. eResearchTechnology provides technology and services to the pharmaceutical, biotechnology and medical device industries.
• Ethicon Endo-Surgery (Cincinnati) reported the launch of the Universal Mammotome MR biopsy system, its magnetic resonance imaging (MRI) breast biopsy device that has all the features of the company’s first Mammotome MR and is compatible with a wider variety of breast coils and magnets and can work with most grid/cube localization systems, the most common method of MR lesion targeting. Under MRI guidance, the device gently vacuums, cuts and partially or completely removes suspicious breast tissue for evaluation. The biopsy incision is so small that only an adhesive bandage is needed to cover it, no sutures are required, and there is minimal scarring. Most patients return to normal activity immediately following the procedure. The outpatient procedure can be performed in an MRI suite and typically takes an average of 30 minutes. Ethicon Endo-Surgery, a Johnson & Johnson (New Brunswick, New Jersey) company, makes devices for minimally invasive and open surgical procedures.
• Safety Syringes (Carlsbad, California) reports another user of the UltraSafe passive delivery system for their prefilled syringe presentation. Shire Pharmaceuticals (Basingstoke, UK) has recently launched Dynepo epoetin delta in Germany with the UltraSafe passive delivery system, completing the initial step of a larger-scale launch program planned for Europe over the coming several months. Dynepo epoetin delta is a unique erythropoesis-stimulatiung agent (ESA), as it is the only ESA produced in human cells. ESAs are agents used in the treatment of anemia to increase the production of red blood cells. Dynepo is produced by activating the erythrpoetin gene in human cells. All other commercially available ESAs are presently made in animal cells. Dynepo epoetin delta is packaged in prefilled syringes using the UltraSafe Passive delivery system. The syringe is designed for ease of use by both healthcare professionals and patients and features a needle safety system to reduce needlestick injuries. The needle is immediately protected after administration of the injection and activation of the safety mechanism requires no action by the user. Safety Syringes make drug delivery systems for pre-filled glass syringes.