• Card Guard (Rheinfall Switzerland), the parent company of LifeWatch (Rosemont, Illinois), said that it received FDA clearance for its LifeStar ACT III platinum system. The new 3-lead version offers the same full auto-detect and auto-send device functionality and therefore does not require any patient interaction. The LifeStar ACT system can automatically detect and send heart rhythm abnormalities to a LifeWatch monitoring call centre that is staffed 24/7 by specialized cardiac technicians who can immediately interpret the data and initiate any necessary next steps. LifeWatch, through its operating subsidiaries Lifewatch Services, and LifeWatch Technologies, makes ambulatory cardiac monitoring services.
  • Connectyx Technologies (Palm City, Florida) reported the launch of its new version of MedFlash at the 33 stores of the QFC Division of Kroger. Ronn Schuman, the company's CEO, said, "We are very excited about the Quality Food Centers launch of our MedFlash personal health record (PHR) and lifestyle portal. We have taken a revolutionary step in creating an easy to use PHR, as well as adding features that will allow consumers to manage all areas of their lifestyles, focusing on wellness. The new version of MedFlash will allow users to log on to their personal health record either by accessing their MedFlash device, or by going directly to the MedFlash Web portal on the Internet. MedFlash also will give customers access to other health records and portals with plans in the near future to integrate with hospitals, insurers and other emergency medical persons who want to use this innovative gateway." Connectyx Technologies specializes in personal health records management.
  • Cook Medical (Bloomington, Indiana) reported the first human use of Cook's Zenith Low Profile AAA endograft system. Currently, delivery systems for endografts to treat aneurysms in the abdominal and thoracic regions of the aorta must be inserted through incisions in the femoral arteries because they are most often too large in diameter to be easily inserted percutaneously. The larger diameter sheath also means the device is stiffer, making it more difficult to negotiate through narrow, tightly curved arteries to reach the diseased section of the aorta where the endograft needs to be deployed. The Zenith Low Profile AAA endograft system addresses those areas of concern by reducing the size of the delivery sheath to 16 French. This development, if proven safe and effective in an upcoming clinical trial, could open endovascular treatment of aneurysms to a new class of patients who currently have only open surgery as a treatment option due to the small diameter of their blood vessels and other anatomic issues. Cook Medical specializes in diseases of the aorta.
  • Invitrogen (Carlsbad, California) said that it received FDA clearance for its DynaChip antibody analysis system. The DynaChip system is an automated chip-based system for human leukocyte antigen (HLA) antibody detection and identification. Invitrogen says the DynaChip provides fully integrated instrumentation, reagents and software for automated detection and identification of HLA antibodies. Invitrogen makes life science technologies for disease research, drug discovery, and commercial bioproduction.