• BioSphere Medical (Rockland, Massachusetts), which is pioneering the use of bioengineered microspheres in embolization procedures, reported its participation in a Phase II, single-arm clinical study to treat patients with primary liver cancer. The 30-patient, two-year study combines, for the first time, Avastin (bevacizumab) from Genentech (South San Francisco, California) with chemoembolization therapy using BioSphere's Embosphere Microspheres. Patients will receive Avastin intravenously one week before and two weeks after undergoing a chemoembolization procedure. The study, expected to begin this month at the Johns Hopkins University School of Medicine, is designed to study the safety and efficacy of combining chemoembolization with Avastin in patients with advanced liver cancer.

• eCardio Diagnostics (The Woodlands, Texas), a provider of advanced ambulatory cardiac monitoring products and services, reported the launch of the eTrigger AF920 event monitor for detection of atrial fibrillation among asymptomatic patients. The eTrigger is equipped with an embedded algorithm that automatically detects and records asymptomatic events without patient activation. eCardio Diagnostics will showcase its eTrigger AF920 device at Pri-Med MidWest, which begins today in Chicago. The company also will be featuring its Holter, patient-activated and post-event monitors.

• GE Healthcare (Waukesha, Wisconsin) said it showcased its updated Vivid cardiovascular ultrasound platform at the recent American Society of Echocardiography meeting in Baltimore. The Vivid 7 Dimension '06, a PC-based, software, raw data ultrasound platform, is designed to help clinicians assess cardiovascular anatomy and left ventricular function with more accuracy by making 4-D cardiovascular imaging easier to use during clinical exams. The Vivid 7 features multi-dimensional imaging formats, real-time, ungated, unspliced 4-D imaging and real-time 4-D full-volume imaging in an easy to use package. New quantitative analysis tools include advanced tissue synchronization imaging and automated function imaging.

• GulfStream Bioinformatics (Lexington, Massachusetts), a provider of comprehensive web-based software solutions for biomedical research and drug development, reported the release of the next generation of its flagship product for biospecimen management and advanced data annotation, BIGR 5.0. The BIGR 5.0 and KnowledgeCapture – its newly developed partner technology in information modeling and data acquisition – platforms include advances in process and workflow control, clinical data annotation, and collaborative data management. They also feature comprehensive disease-based informatics modules that enable the flexible input of large quantities and varieties of data and the rapid output of user-desired models and analysis.

• Medwave (Danvers, Massachusetts), maker of sensor-based, noninvasive blood pressure measuring solutions, reported that it has submitted a 510(k) application to the FDA for its Fusion Non-Invasive Patient Monitor System with Vital Signs Options. Fusion offers Medwave's sensor-based blood pressure solution, while also incorporating pulse oximetry from Nellcor (Pleasanton, California) and thermometry from Kendall (Mansfield, Massachusetts). Fusion can be configured from a stand-alone blood pressure device into a complete vital signs monitor. According to the company, it is the first noninvasive blood pressure and vital signs monitor that is purely sensor-based.

• Nanomix (Emeryville, California), a nanoelectronic detection company commercializing diagnostic and monitoring applications, reported that it was issued U.S. patent No. 7,036,324. The new patent is related to hydrogen storage technology and follows five earlier patents issued to Nanomix in this field. The new technology avoids the current limitations of liquid hydrogen storage. The system employs a combination of thermal insulation and an enclosure for the storage and controlled distribution of hydrogen as a high-energy fuel. This can address storage life limitations, energy penalties, and/or weight penalties associated with liquid hydrogen, metallic hydride and high-pressure gas-phase hydrogen storage.

• Phase Forward (Waltham, Massachusetts), a provider of data management solutions for clinical trials and drug safety, reported the new InForm Adapter module, providing customers with enhanced integration capabilities for the InForm Integrated Trial Management (ITM) electronic data capture solution. With the InForm Adapter module, InForm ITM users can leverage a set of web services-based interfaces to access data and event information stored in the InForm database. The InForm Adapter module is versioned independently to provide maximum maintenance and upgrade flexibility. Security is assured through the use of standards-based Secure Sockets Layer certificates, Windows authentication and Security Assertion Markup Language authentication and authorization.

• Repligen (Waltham, Massachusetts), developing therapeutics for neuropsychiatric disorders and autoimmune disease, reported that the company has initiated a clinical trial to evaluate the use of RG1068, synthetic human secretin, as an agent to improve the detection of structural abnormalities of the pancreatic ducts during MRI imaging of the pancreas. In the multi-center, baseline-controlled, single-dose study, 80 patients with a history of pancreatitis will receive a secretin-enhanced MRI and an unenhanced MRI of the pancreas. The study will assess the sensitivity and specificity of secretin-enhanced MRI to improve the ability to detect pancreatic duct abnormalities relative to unenhanced MRI, as well as the safety of secretin in combination with MR.

• Sorin Group (Milan, Italy), a provider of cardiac rhythm management therapies, said it would showcase its latest Ovatio implantable cardioverter defibrillators (ICDs) and other new technologies at Cardiostim 2006 this week in Nice, France. The company said the Ovatio, at 29 cc, is the world's smallest ICD. Two of Ovatio's exclusive features, AAIsafeR and PARAD+, will be discussed during the symposium “ICD Patients: Answers to Conflicting Needs.” AAIsafeR is a pacing mode capable of reducing ventricular pacing to only 0.2% in Ovatio DR patients with intact conduction. PARAD+, an algorithm for reducing inappropriate shocks, is capable of accurately differentiating ventricular tachyarrhythmias and treating the full spectrum of arrhythmias through anti-tachycardia pacing. Other Sorin Group innovations will be presented during a live implant session, including Brady Tachy Overlap, a feature available in Ovatio CRT for the treatment of heart failure; and Peak Endocardial Acceleration, a sensor that detects the strength of the heart's contractions, for CRT in heart failure patients.

• TomTec Imaging Systems (Munich, Germany) said it is introducing its new diagnostic tool for cardiac resynchronization therapy (CRT). The 4D LV-Analysis software is a tool for comprehensive left ventricular (LV) analysis based on 3-D echocardiographic datasets. Newly established dyssynchrony Systolic Dyssynchrony Index cut-off values now allow better patient selection, as well as the identification of patients who are currently not considered for CRT but may also benefit. 4D LV-Analysis features advanced automatic contour finding algorithms for a fast, accurate and reproducible functional analysis of the left ventricle, even for difficult-to-image patients. 4D LV-Analysis also offers analysis options like 3-D Parametric Imaging, which simplifies dyssynchrony assessment and allows the exact localization of areas with delayed myocardial contraction.