• Lifeline Biotechnologies (Reno, Nevada) said that the company’s recent meeting with the managing engineer of Nanyang Technical University concerning the finalization of the first warning system (FWS) patient data interpretive software was encouraging. Additional cases of patient data were received, downloaded and reviewed by the development team at the university and the upgrading of the FWS can be accelerated. The new advancements could allow the FWS to classify women who have periodic breast examinations to identify normal, suspicious and positive ranges for breast cancer. The preliminary estimate is that an additional 300 patients will need to be tested and the company is determining the period of time required to complete this testing. Preliminary estimates by Lifeline’s management suggest the possibility of completion in 2008. Lifeline Biotechnologies is focused on completing the development of the first warning system, which was designed to assist in the early detection of breast cancer.
• MergeHealthcare (Milwaukee) reported the introduction of eFilm Workstation version 3.0, an enhanced version of Merge’s desktop diagnostic imaging software. eFilm offers enhancements in both a gold version and a platinum version that are designed to accelerate radiologist productivity. With a range of tools, including window/level presets, synchronized stacking, MPR reference lines, cine function and integrated CD burning — in addition to other capabilities such as volume rendering and MPR creation — eFilm supports the daily workflow of any imaging environment. eFilm also can be used as a back-up viewer during disaster recovery if an existing PACS goes off-line. Merge Healthcare is a medical imaging software and services provider.
• Omnicell (Mountain View, California) introduced its SinglePointe total automated patient-specific management solution, which is the first in the industry. The SinglePointe solution provides an auto-assign process that matches patient-specific locations with patients and their medications that are not routinely stocked in the dispensing system. This feature significantly reduces the labor intensive process of loading and unloading medications in the dispensing system as well as the management of multi-use and “home” medications. Whether the patient is transferred or discharged, the SinglePointe solution’s user intuitive workflow results in improved control and accountability of these patient-specific medications. Omnicell provides system solutions targeting patient safety and operational efficiency in healthcare facilities.
• Phase Forward (Waltham, Massachusetts) reported availability of version 2.6 of its Web Submission Data Manager (WebSDM) product. The WebSDM 2.6 software reads data from Phase Forward’s InForm integrated trial management electronic data capture product, providing data managers with the ability to better understand the overall data quality of records under review. By enabling data managers to evaluate data more thoroughly at an earlier stage, the combined products can help to detect anomalies and trends to support safety analysis. The WebSDM product checks data for conformance with the clinical data interchange standards consortium study data tabulation model, creating a data repository that is then available for review and reporting purposes. Phase Forward makes data management solutions for clinical trials and drug safety.
• PLC Systems (Franklin, Massachusetts) reported that it has discussed the results of its pilot safety study of the RenalGuard system and therapy with the FDA. Based upon the positive safety data already collected in the pilot study and its discussions with FDA, PLC has stopped enrolling new patients in the pilot study and will submit a request to transition into a new pivotal trial protocol. The trial is expected to demonstrate that RenalGuard is effective in reducing the incidence of contrast-induced nephropathy (CIN) in at-risk patients undergoing cardiovascular imaging procedures. PLC Systems specializes in technologies for the cardiac and vascular markets.
• Reliant Technologies (Mountain View, California) reported that its Fraxel re:pair laser system has received FDA clearance for a fractional ablative treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia. The system, initially cleared for ablation, coagulation and skin resurfacing, becomes the only fractional ablative resurfacing system cleared by the FDA for specific indications of use. It is capable of being operated by a single clinician, because of its built-in smoke evacuation system, and capable of treating at depths from 300 micrometers to 1.6 mm into the dermis, all in a single handpiece. The laser delivers FMDAtreatments for superficial photodamage, including pigmentation, fine lines, texture and vascular dyschromia. It also has the flexibility to deliver FDDA treatment for more severe rhytids and furrows by stimulating new collagen and elastin production deep into the dermis. Treatment is delivered with the safety and proven efficacy of a Fraxel brand treatment.