Science and Enterprise

Category: Regulations

  • Calculator Estimates Individual Surgical Complications Risk

    Medical researchers with American College of Surgeons devised an online system that calculates an individual’s risk of developing complications for nearly all kinds of surgery. The team led by Karl Bilimoria, director of the Surgical Outcomes and Quality Improvement Center at Northwestern University in Chicago, with colleagues from the UCLA medical center and VA Greater…

  • FDA Clears Enhanced Capsule Camera for GI Disorders

    The Food and Drug Administration cleared for sale in the U.S. a new version of a tiny camera in a capsule, made by Given Imaging Ltd. in Yoqneam, Israel, and swallowed by patients to diagnose gastrointestinal (GI) conditions. The company expects its PillCam SB3 to be available in the U.S. in the last quarter of…

  • FDA Funds Organ-on-Chip to Test Radiation Disease Treatments

    The U.S. Food and Drug Administration awarded a contract to a Harvard University lab for simulated organ devices to test radiation disease countermeasures. The $5.6 million award will fund the work of Harvard’s Wyss Institute for Biologically Inspired Engineering from FDA’s research and development program on regulatory science and medical countermeasures initiative. Wyss Institute researchers,…

  • Telemedicine Found to Improve Rural Pediatric Emergency Care

    A study of rural emergency room cases in northern California shows physician consultations with teleconferencing result in higher quality of  care for seriously ill and injured children. The findings of pediatrician James Marcin and colleagues at University of California in Davis were published yesterday online in the journal Critical Care Medicine (paid subscription required). Telemedicine…

  • Trial Testing External Power Connections for Heart Pumps

    A clinical trial testing alternative connections for external powering of implanted heart pumps is enrolling patients at University of Maryland Medical Center in Baltimore, one site of the study. Bartley Griffith, a cardiac surgeon and professor of surgery is leading the research for the university, which is funded by Jarvik Heart Inc., maker of one…

  • Community Pharmacies Found Helpful in Encouraging HIV Tests

    Medical researchers at Albert Einstein College of Medicine of Yeshiva University in New York found local pharmacies can serve as venues to offer rapid HIV screening and get medical care for those who test positive. The team from Einstein College and its affiliated Jacobi Medical Center in the Bronx published its findings in this month’s…

  • FDA Approves Shipping of GSK Four-Strain Flu Vaccine

    The global pharmaceutical company GlaxoSmithKline says the U.S. Food and Drug Administration gave its approval to ship the company’s vaccine covering four potential virus strains for the 2013-2014 influenza season. GSK says this year will be the first that vaccines will be available to protect against more than three strains of flu. FDA approved GlaxoSmithKline’s Fluarix…

  • Sugary Drink Taxes Can Cut Calories, Health Impact Limited

    Economists and public health researchers at RTI International and Duke University in North Carolina, and U.S. Department of Agriculture forecast that taxes on sugary drinks can reduce the calorie intake of consumers, but the overall health impact is limited by consumers shifting to other less healthy, but untaxed, items. Chen Zhen and colleagues published their…

  • Health Portals Capture App Data to Drive Wellness Engagement

    Health care providers and insurance companies want to get their customers healthier, and have customers record their wellness data to track their progress, with some health app developers eager to help out. Speakers on Friday, 26 July at the mHealth + Telehealth World Congress in Boston gave examples of recent health and wellness initiatives making…

  • Telemedicine Facing Financial, Regulatory Headwinds

    Health care organizations with telemedicine programs run into challenges implementing their services, particularly in getting acceptance from payers, and meeting legal or regulatory requirements across multiple jurisdictions. These issues arose in two sessions today at the mHealth + TeleHealth World Congress in Boston. A key financial issue is reimbursement by insurance companies for telemedicine services.…