Biofield (Alpharetta, Georgia) said the FDA has sent a response to a recent meeting at which the company had reviewed with the FDA the data contained in the company's previously submitted 510(k) application, with the goal of streamlining the eventual submission of Biofield's premarket approval application. The FDA informed the company that the data contained in the 510(k) application would be insufficient "for several reasons," including a request for more clinical testing. The company said it is working on a strategy to respond to the FDA's concerns. Biofield has developed a non-invasive system to deliver objective results that may be helpful in the early detection of epithelial cancers, including breast cancer. Use of its Breast Cancer Detection System (BDS) may distinguish those lesions likely to progress and cause significant disease and death, the company said. It added that the BDS may reduce diagnostic uncertainty as well as decrease the number of diagnostic procedures, performed on suspicious palpable breast lesions.
Taylor Madison (Orlando, Florida), doing business as Telzuit Medical Technologies, and its wholly-owned subsidiary, Telzuit Technologies, doing business as BioPatch Systems, reported that Taylor Madison has filed for a patent with the U.S. Patent and Trademark Office for a wireless home sleep apnea test. The company said it intends to immediately prepare and file a 510(k) application with the FDA. Taylor Madison/Telzuit will market the new product along with its Holter Monitor and Event Monitor using the BioPatch platform.
Varian Medical Systems (Palo Alto, California) is introducing a new version of its Eclipse radiotherapy treatment planning software that substantially speeds up the process of planning complex radiotherapy treatments. The company said the new release incorporates new planning protocols and easy-to-use optimization tools that make it easier and faster to plan cancer treatments such as intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT). The new Eclipse release incorporates a set of treatment plan templates that streamline the process of creating a personalized plan for each patient based on the patient's diagnostic images and the physician's dose prescriptions. Varian's "AAA" dose calculation algorithm, which more accurately calculates radiation dose distributions in heterogeneous areas of the body such as the lung, also has been updated and is four times faster than the previous version. Eclipse now also incorporates a new automated segmentation tool that speeds up contouring, the process by which doctors separate diseased tissues from surrounding healthy organs on a set of 3-D diagnostic images in order to specify exactly where radiation dose levels are to be concentrated and which areas are to be protected. Another new feature, Remote Connect, enables clinicians to use a virtual private network and high-speed Internet connection to access their treatment planning systems remotely.