• Cytogen (Princeton, New Jersey) reported outcomes data from a cohort study demonstrating the value of Prostascint (capromab pendetide) in predicting prognosis in prostate cancer. The study evaluated the outcomes of patients whose Prostascint images showed uptake in the central abdomen, a finding suggestive of metastatic disease, as compared to those without such findings. Prostascint is a monoclonal antibody-based agent that targets prostate-specific membrane antigen (PSMA) to image the extent and spread of prostate cancer. Prostascint consists of Cytogen’s PSMA-targeting monoclonal antibody, 7E11-C5, linked to the imaging radioisotope Indium-111. By targeting PSMA, the Prostascint molecular imaging procedure can detect the extent and spread of prostate cancer using a standard gamma camera. Cytogen is a pharmaceutical company specializing in oncology products.

• GE Healthcare (Waukesha, Wisconsin) reported FDA clearance for its Carescape patient data module for mobile patient monitoring. The Carescape features 24-hour capture of patient data and a close-to-the-patient, self-powered design that alleviates common portability constraints. The module ensures that the receiving nurse has a complete monitoring history when a patient arrives. Its design allows it to stay with the patient to capture and store all patient measurements — both standard and specialty. GE Healthcare specializes in medical imaging and information technologies.

• GlucoLight (Bethlehem, Pennsylvania) reported the successful conclusion of the company’s first clinical study to evaluate their continuous non-invasive glucose monitor in the ICU environment. The principal objective of this first ICU study was to test the form and function of GlucoLight’s Sentris-100, a continuous, non-invasive blood glucose-monitoring device for the acute care environment. Over the course of the study, 30 patients that had undergone cardiac surgery with cardiopulmonary bypass were enrolled at the participating centers. The study provided over 1,000 hours of data, collected for analysis and interpretation by GlucoLight. GlucoLight is targeting the first introduction of the Sentris-100 in the ICU, where tight glycemic control has been shown to significantly improve survival, yet current monitoring provides only intermittent information. GlucoLight is a development-stage company focused on blood glucose monitoring in the acute care environment.

• Home Diagnostics (Fort Lauderdale, Florida) reported the launch of TrackRecord data management software, an electronic diabetes management system that enables people with diabetes, and healthcare professionals who treat them, to better understand how various lifestyle and behavior choices impact blood glucose levels. TrackRecord DMS is designed for use with Home Diagnostics’ blood glucose meters, including TrueTrack and Prestige IQ. Home Diagnostics makes diabetes testing supplies.

• Roche Diagnostics (Indianapolis), in cooperation with the FDA, announced that the Urgent Medical Device Correction issued for CoaguChek PT test strips (UMDC 06-266), used in anticoagulation monitoring, has been addressed and duplicate testing is no longer required for CoaguChek PT Test Strips, lot numbers 560A and higher (e.g., 561A, 562A, ...). The potential for erroneous prothrombin time (PT) test results that prompted the UMDC was a result of insufficient active ingredient (thromboplastin) on selected test strips. Fully tested and validated changes have been implemented within the manufacturing process to address this concern. All healthcare professionals performing duplicate testing to confirm results can return to a single test using CoaguChek PT Test Strips (only from lot numbers 560A and higher) to monitor patients on warfarin (anticoagulation) therapy. All patients previously performing patient self-testing may now resume monitoring with CoaguChek PT Test Strips (only from lot numbers 560A and higher). Roche is a research-focused healthcare group in the fields of pharmaceuticals and diagnostics.

• ZOLL Medical (Chelmsford, Massachusetts) reported receiving FDA clearance for its ZOLL E Series with See-Thru CPR technology. This CPR quality improvement benefit is provided by extracting the “artifact” (unwanted visual aberrations in the electrocardiograph [ECG] signal) caused by chest compressions. See-Thru CPR’s processing technology actually extracts the CPR artifact and shows a “filtered” ECG on the defibrillator screen, allowing rescuers to see organized cardiac rhythm without stopping compressions. The AHA notes that a primary source of interruption of CPR results from stopping to determine if an organized rhythm that can be defibrillated has developed. ZOLL makes resuscitation devices and related software solutions.

No Comments