• Medicsight (London) said it has received a Request for Additional Information (AI) letter from the FDA. This request is in regard to the 510(k) pre-market notification for the ColonCAD API 3.1 product. The FDA has requested clarification of the intended use of the product. Medicsight is collating the information required, will continue discussions with the FDA and will provide a response to the agency in due course. Medicsight is a subsidiary of MGT Capital Investments, and a maker of computer-aided detection and image analysis software, which assists radiologists in the early detection of disease.

• MedX Health (Mississauga, Ontario) said it has received FDA approval to study the effectiveness of laser acupuncture for addiction to nicotine, alcohol and drugs. The MedX multi-center trial will determine the effectiveness of laser acupuncture for treating a number of major health conditions that significantly contribute to morbidity and mortality. Laser Auriculotherapy is the stimulation of points on the external ear and in some cases meridian points in other parts of the body, to aid many health conditions, especially pain, stress and addiction. Based on years of experience, experts believe that this stimulation will lead to a reduction in the patient's need for the substances. The reduced cravings outcome with laser auricular acupuncture is based on the recent observation that the ear represents a door into the endocrine and autonomic nervous systems. In 1997, a consensus panel of the National Institutes of Health gave approval to the practice of acupuncture, which included an evaluation of those studies which supported the use of ear acupuncture for pain and addiction.

• NovoCure (Haifa, Israel) said that newly published data show that the Novo-TTF device combined with standard chemotherapy (temozolomide) demonstrated a three-fold increase in time to progression (TTP) and a five-fold increase in overall survival (OS) for patients with newly diagnosed glioblastoma multiforme (GBM), when compared to historical controls. This study of the Novo-TTF, a non-invasive medical device that uses low intensity alternating electric fields to destroy cancer cells was published in BMC Medical Physics in January. The Novo-TTF device disrupts cancer cell proliferation and tumor growth by generating low intensity, intermediate frequency, alternating electric fields within a tumor. These electric fields exert forces on polar structures within the dividing cancer cells that prevent tumor growth. In pre-clinical and clinical studies to date, the electric fields have shown no effect on non-dividing, healthy cells in the same region, suggesting that the device can treat cancer without harming surrounding tissue, unlike chemotherapies that are typically associated with high toxicity resulting in serious side effects.

• Opko Health (Miami) has received FDA clearance to begin marketing its Spectral OCT SLO Combination Imaging System. With the Spectral OCT SLO, high-resolution images are produced with inner retinal choroid and vitreous detail that allow for improved monitoring of ophthalmic disease progression or regression. The Spectral OCT SLO is a non-contact, high-resolution non-invasive tomographic and confocal imaging device indicated for in vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of posterior ocular structures including: retina, macula, retina nerve fiber layer and optic disk. It is used as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye. Separately, Opko Health said it has begun treating patients in a clinical trial of its Aquashunt, a device for the treatment of refractory open angle glaucoma. The study is designed to assess the safety and efficacy of the Aquashunt and will enroll up to 20 patients with significantly impaired visual acuity. The Aquashunt is a device designed to lower intraocular pressure by allowing excess fluid in the eye to exit more naturally than occurs with presently available devices.

• SensAble Technologies (Woburn, Massachusetts) reported the introduction of touch-enabled applications using the company's haptic devices and software that show how SensAble sets the standard for innovative touch-enabled medical training and simulation. These include a skin cancer punch-biopsy training application already piloted by seven medical schools, and a spinal implant training application that prevents physicians from harmful radiation exposure. SensAble also is showcasing advanced haptic capabilities for medical simulation made easier by its OpenHaptics version 3.0 software development toolkit for creating touch-enabled applications.

• Zoll Medical (Chelmsford, Massachusetts) said it received FDA clearance to market and sell the new Zoll R Series BLS and R Series Plus defibrillators. The R Series Plus, which has both AED and ALS capabilities at the touch of a button, also has networking capabilities and See-Thru CPR, which allows the professional rescuer to view a patient's underlying cardiac rhythm during resuscitation efforts without the need to stop compressions to see if defibrillation was successful. These models provide the Real CPR Help feature that provides real-time feedback on the rate and depth of chest compressions. In addition, all R Series models can use wireless networking to ensure code-readiness. Based on standard 802.11b WiFi technology, the R Series automatically sends a status of its state of readiness at a programmed time.