A Medical Device Daily
Global Research Services (GRS; Rockville, Maryland) reported an alliance with CardioDynamics (San Diego), authorizing GRS to use CardioDynamics' impedance cardiography (ICG) technology for processing of noninvasive hemodynamic ICG data.
CardioDynamics says that its ICG products enable GRS to provide expanded biometrics and data management services in support of clinical trials and offering enhanced cardiac safety monitoring in Phase I through IV clinical trials.
GRS said it recently completed several programs using this technology to rapidly upload data from CardioDynamics' BioZ ICG technology and BioZport application software.
Investigators and sponsors can view reports and detailed cardiovascular tables and graphs created from real-time trial data through secure online portals, assisting in faster decisions related to dose selection, safety outcomes, and therapeutic efficacy of cardio-active agents.
CardioDynamics' BioZport was designed to meet FDA's 21 CFR Part 11 and HIPAA requirements and provides real-time transmission of ICG data for rapid assessment of both desired and adverse effects of candidate compounds.
In other agreement news: CytoCore (Chicago), a developer of cancer screening systems, reported its first U.S. distribution agreement and first U.S. order for its SoftPAP cell collector, a sample collection device, with CoMedical (Seattle, Washington), which serves healthcare professionals in Washington, Oregon, Idaho, Montana, Wyoming and Alaska. The company says it represents small product manufacturers by introducing their products to "targeted" healthcare professionals.
CytoCore says that the SoftPAP Cervical Cell Collector offers a quick, accurate specimen collection for the Pap test with minimal possibility of user error. SoftPAP is designed to collect a full 360 degree specimen from both the cervical canal and the outer surface of the cervix. It is designed to consistently sample the entire cervix in a single-step, using an inflatable balloon collector.
The patented single-use silicon balloon is a mirror image of the surface of the ecto- and endo-cervix. During collection, the balloon is slightly inflated by pressing a button on the collector handle. The volume of air is fixed and controlled so no over- or under-inflation can occur. The balloon is designed so that regardless of the shape of the cervix, when the balloon inflates, the balloon's surface comes into contact with all walls of the cervix that need sampling in a single step. Cells are collected from 360 degrees around the ecto-cervix, and from within the endo-cervix by touch.
CytoCore said that studies have shown that SoftPAP reduces patient adverse events, primarily bleeding and spotting, thus helping to overcome patient reluctance to the Pap test, thus increasing early detection of HPV and potentially related cervical dysplasia.