Imaging Diagnostic Systems, Inc., (OTCBB: IMDS), a pioneer in laser optical breast imaging, announced today that the Australian Government Department of Health and Ageing Therapeutic Goods Administration has approved the CT Laser Mammography (CTLM® ) system for inclusion on the Australian Register of Therapeutic Goods (ARTG). The Therapeutic Goods Administration (TGA) must approve the inclusion of all medical devices on the Register before devices can be sold in Australia. "Gaining approval in Australia is an important step for us. It enables us to reach the Australian market and to perhaps influence related markets, " stated Deborah O'Brien, IDSI's Senior Vice President.
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized 77 ozone generators, models AOS-1M and AOS-1MD, from Applied Ozone Systems of Auburn, Calif. The seized goods, which are medical devices, are valued at $75, 900. The FDA advises health care professionals and consumers to discontinue use of these devices, which Applied Ozone Systems claims can treat cancer, AIDS, hepatitis, herpes, and a number of other diseases and conditions. The FDA has not determined that the seized products are safe and effective in treating the diseases or conditions, and officials at Applied Ozone Systems never responded to a Dec. 21, 2009 FDA request for a voluntary recall of these ozone generators.
Children who have cochlear implants (CI) rank their quality of life (QOL) equal to their normally hearing (NH) peers, indicates new research in the February 2010 issue of Otolaryngology - Head and Neck Surgery. A cochlear implant is an electronic device that restores partial hearing to the deaf. It is surgically implanted in the inner ear and activated by a device worn outside the ear. Unlike a hearing aid, it does not make sound louder or clearer. Instead, the device bypasses damaged parts of the auditory system and directly stimulates the hearing nerve, allowing deaf or severely hard of hearing individuals to receive sound. The National Institutes of Health estimate that as many as 59, 000 people worldwide have received cochlear implants, with roughly half of those in the pediatric population.
Understanding & satisfying payer & stakeholder needs to demonstrate cost-effectiveness & product value Conference dates: 18th-19th March, 2010 Venue: Budapest, Hungary Event Overview Increasing national healthcare budgetary pressures, are forcing manufacturers to think out of the box and implement more innovative reimbursement models and value-based schemes. Demonstrating product value with data that really counts in payers', regulators' and other stakeholders' decision-making processes, is essential in order to gain and retain access in key markets. Budgetary pressures however, could also present an opportunity to the medical devices industry.
A new testing method is being developed to detect cancer soon after the tumor has formed. It will identify characteristic substances in the blood which accompany a certain type of tumor. The first steps in the development have already been completed. The earlier the doctor finds the tumor, the better the patient's chances of recovery. A new testing method aims to detect the disease in its initial stages. The technology is based on a microfluidic chip with tiny channels in which a blood sample from the patient circulates. The chip traces marker proteins which are indicative of cancer. The measured concentration of the tumor marker in the blood will help doctors to diagnose the disease at an early stage.
The Regenerative Medicine Foundation has announced the first annual Translational Regenerative Medicine Forum to be held April 6-8, 2010 at the Benton Convention Center in Winston-Salem. The forum seeks to advance the field of regenerative medicine and health care innovation through the sharing of scientific discoveries, clinical and corporate best practices and business models. Reflecting the global scope of regenerative medicine, the meeting will feature keynote speakers and panelists providing a domestic and international perspective, including critical areas such as clinical advances, trial design, venture funding and obtaining regulatory approval.