• Aspect Medical Systems (Norwood, Massachusetts) has received FDA clearance for the BIS View Monitoring system, the company’s newest stand-alone monitor. The monitor offers customers a compact design and simplified operation for lower acuity clinical environments with limited room for monitoring equipment. According to the new indication for use statement cleared by the FDA, Bispectral Index (BIS) monitoring may be used as an aid in monitoring the effects of certain anesthetic agents and may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. Using a sensor placed on the patient’s forehead, BIS monitoring translates information from the electroencephalogram into a single number that represents each patient’s level of consciousness. This number — the BIS value — ranges from 100 (indicating an awake patient) to zero (indicating the absence of brain activity). Using the BIS value to guide administration of anesthetic medication, clinicians can make informed decisions for optimal anesthesia or sedation. Aspect Medical Systems specializes in brain monitoring technology.
• Imaging Diagnostic Systems (Ft. Lauderdale, Florida) reported the release and publication of select results highlighting the advantages of using CT laser breast imaging as an adjunct to conventional mammography to improve detection of occult cancers in dense breasts. The study demonstrated that, in a dense breast population, the adjunctive use of CTLM, classifying DCIS as malignant, increased sensitivity from 50% to 58.3% over mammography alone and improved specificity from 75.5% to 86.8%. When DCIS is classified as pre-malignant, the figures changed slightly, increasing sensitivity from 43.8% to 56.2% over mammography alone and improving specificity from 73.6% to 84.4%. The difference between the two sets of results reflects that the pathologically ‘benign’ form of DCIS shows angiogenesis in only 30% of cases, whereas comedocarcinoma shows angiogenesis in 75%, an observation that that might prove useful for stratifying DCIS for treatment purposes. Imaging Diagnostic Systems specializes in laser optical breast imaging systems.
• Novadaq Technologies (Toronto) reported the results of the first clinical experience utilizing the Helios fluorescence imaging system. The study confirmed that the use of intra-operative real-time laser- assisted fluorescent imaging during free-flap breast reconstructive surgery may result in improved intra-operative decision making for surgeons performing complex plastic surgery procedures and ultimately positively impact procedural outcomes for patients. Novadaq also reported that results from a pilot study of the use of the Luna imaging system during surgery for kidney cancer were recently presented at the 2007 annual meeting of the American Urological Association. The study included detailed analysis of images obtained using the Luna system during 10 kidney cancer surgeries. Results showed that LUNA allowed surgeons to differentiate between healthy and malignant cancerous tissue which enabled more precise removal of the malignant tissue while preserving as much healthy tissue as possible. A critical factor in the future health of cancer patients. Novadaq makes real-time medical imaging systems and image guided therapies for the operating room.
* Prime Healthcare Services (Victorville, California) launched a 3-D picture archiving communication system (PACS) at the radiology departments at all of its facilities. This high tech investment is considered the next level in imaging excellence and will provide ready access to radiology diagnostic images. PACS streamlines care by providing real time high resolution radiology images that can be accessed via the Internet within minutes. The equipment comes with sophisticated array of provisions like enhanced security to protect patient privacy, vast storage for lasting images, voice recognition for physicians to instantaneously generated dictated reports, multiple access so physicians or other medical professionals can view results from any computer in the hospital and ability to provide printed film or digital copies of the images to the patients. Prime Healthcare Services currently owns and operates eight acute care facilities.
* Sequenom (San Diego) and Lenetix Medical Screening Laboratory (Mineola, New York) reported that Lenetix has submitted a clinical package to the New York State Department of Health to support its application for a clinical laboratory permit to perform a non-invasive prenatal Rhesus D (RhD) incompatibility test, the first non-invasive prenatal test based on Sequenom’s Fetal Nucleic Acid Technology. Lenetix’s RhD application of Sequenom’s fetal nucleic acid technology detects a fetus’ RhD status from the mother’s blood sample without invasive procedures that typically pose risk to the health of the mother and baby in utero. Lenetix makes genetic screening and diagnostic testing products.