• Avid Radiopharmaceuticals (Silver Spring, Maryland) reported that the FDA's Peripheral and CNS Advisory Committee provided strong support for development of amyloid imaging agents to test for the presence or absence of Alzheimer's disease pathology in people with symptoms of cognitive impairment. Avid said its Phase II amyloid imaging compound, ¹⁸F-AV-45 (AV-45), is well positioned to rapidly enter late-stage development based on the advisory committee recommendations. AV-45 was the first amyloid imaging compound to enter multi-center Phase II clinical studies in the U.S. and has now been studied in more than 250 people, ranging from cognitively normal individuals to those with Alzheimer's disease. Avid is currently conducting clinical trials at more than 25 research centers across the US and anticipates initiating Phase III trials early next year.

• Masimo (Irvine, California) the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low Perfusion pulse oximetry, reported that 13 new independent clinical studies presented at the American Society of Anesthesiology annual meeting in Orlando earlier this month found Masimo SET and Masimo Rainbow SET technologies to be crucial in providing clinicians with an early indication of their patients' deteriorating health status in numerous clinical settings, which may allow earlier intervention and prevention of adverse clinical outcomes. Masimo said its exhibit at ASA attracted more than 2,500 anesthesiologists. It said anesthesiologists visiting the commercial exhibit "marveled at" the company's noninvasive hemoglobin (SpHb), the first technology capable of continuously monitoring hemoglobin status. Continuous monitoring of anemic status with Masimo SpHb may allow clinicians to make earlier and better treatment decisions, such as detecting blood loss earlier to initiate more timely transfusions in some patients and avoiding unnecessary blood transfusions in others.

• Medhost (Addison, Texas) said it has extended its product offering to include a patient self-check-in kiosk called Emergency Department Patient Access Self Service (ED PASS). Upon arrival, patients can check in with the touch-screen kiosk. After patients check in, their information instantly becomes visible in the Medhost EDIS, which gives clinicians a real-time view of the waiting room and immediately alerts them to any high-risk patients. The ED PASS features a touch screen interface for simple data entry. With the swipe of a driver's license, patient demographics are immediately captured, and details such as reason for visit, location and intensity of pain or injury, and complaint specific risk factors empower clinicians with rich information about patient background and acuity. Intuitive desktop alerts notify clinicians when a high-risk patient checks in so care can begin without delay.

• Medtronic (Minneapolis) said it has submitted its pre-market approval application to the FDA for InterStim therapy for the treatment of fecal incontinence. InterStim therapy is a reversible treatment for patients with fecal incontinence after conservative treatments have failed. InterStim for fecal incontinence delivers the neurostimulation to the sacral nerve to stimulate the nerves and muscles that control bowel movements. Fecal incontinence can be caused by a variety of factors, including constipation, damage to the nerves or muscles in the rectum (from trauma such as childbirth) or other pelvic health disorders.

• Terumo Heart (Ann Arbor, Michigan) that five patients have received the DuraHeart Left Ventricular Assist System, marking an important early milestone in the U.S. pivotal trial. A team led by Francis Pagani, MD, performed the five implants at the University of Michigan Cardiovascular Center (also Ann Arbor), with three of the surgeries performed off-pump. The off-pump implant procedure offers significant advantages including less operative bleeding and shortened time in surgery. The DuraHeart Bridge-to-Transplant Pivotal Trial is a multi-center, prospective, non-randomized study of 140 patients and will include up to 40 centers. The device is intended to provide cardiac support for patients awaiting transplant who are at risk of death due to end-stage left ventricular failure. Yoshifumi Naka, MD, PhD, of Columbia Presbyterian Hospital (New York), will serve as the co-principal investigator with Pagani.