• BioImagene (Cupertino, California), a provider of digital pathology solutions, reported receiving FDA clearance for the use of its Pathiam Imaging Software for HER2/neu for in vitro diagnostic use. Pathiam is intended for use as an accessory to the Dako HercepTest to aid a pathologist in semi-quantitative measurement of HER2/neu in breast cancer tissue. When used with the Dako HercepTest it is an aid in the assessment of breast cancer patients for whom Herceptin treatment is being considered. The imaging software detects and classifies cells of interest by analyzing digitized images of microscope slides based on recognition of cellular objects of a color, size and shape. The Pathiam analysis algorithm enables pathologists to provide accurate and objective quantitation of tissue samples stained with HER2/neu, BioImagene said. BioImagene is a provider of image informatics solutions for life sciences research, drug discovery and development and digital pathology and has developed a product line from the web-enabled management platform 3i. With the exception of Pathiam Imaging Software for HER2/neu, BioImagene products are for research use only.
• CardioMEMS (Atlanta) reported that its wireless pressure sensor was successfully surgically implanted into the wrist of three severely hypertensive patients at Hospital DIPRECA (Santiago, Chile) by cardio-thoracic surgeons, Miguel Berr, MD, and Michael Tuchek, DO. Following the implants, Berr said the device "was simple to implant and we expect that the information provided will be very useful in the management of this disease." The wireless hypertension sensor is positioned just below the surface of the skin above the patient's radial artery using a minimally invasive procedure. The sensor is designed to allow for a precise and accurate measurement of systemic blood pressure using the CardioMEMS electronics module. The sensor and electronics are designed to allow for additional blood pressure measurements to be taken by the patients at home and to transmit the data wirelessly to a secure database where it will become available for review on CardioMEMS' patient management website. The wireless hypertension sensor and the related electronics are being evaluated as part of a clinical trial and are not approved for marketing.
• Picis (Wakefield, Massachusetts) reported the third release of its Total Perioperative Automation suite, the complete integration of surgical scheduling, supply chain management, revenue management and clinical workflow automation for surgeons, operating room nurses, department managers and anesthesia providers. The client-driven release, consisting of more than 125 new features and 1,100 individual requirements to CareSuite perioperative applications, is designed to further enhance hospital revenues and productivity, improve supply chain management and support Joint Commission reporting requirements.