• AFP Imaging (Elmsford, New York) reported it has begun the delivery and installation of the new model VG (vertical generation) Cone Beam CT X-ray scanners (CBCT) to dentists in the U.S., Canada and Europe. AFP recently received regulatory clearance from the FDA, Health Canada and the CE agencies for this new model. VG allows the patient to stand, sit or stay in a wheel chair while they are scanned in an upright, vertical position, using a conical beam of x-rays that passes around the head, allowing the capture of a three dimensional, digital radiographic image of the patient’s teeth and jaw structures. The company’s technology includes software to capture and quickly display these detailed images. 3D applications are vital for orthodontics, implants and oral surgery, among others, where complex cases require sophisticated imaging to plan the treatment procedure. AFP said it expects significant growth of profitable revenues from this new product. AFP’s entry into the CBCT market was achieved in April 2007 through the acquisition of QR (Verona, Italy).

• Agendia (Amsterdam, The Netherlands) said it has made its breast cancer prognosis test, MammaPrint, available to U.S. patients after receiving two clearances from the FDA. The first in February cleared MammaPrint as an in vitro diagnostic multivariate index assay for use in breast cancer prognosis. In June, Agendia received a second clearance for the test in conjunction with RNARetain, an RNA stabilizing solution allowing shipping of tumor biopsies at ambient temperature, greatly facilitating the logistical process of sample handling. “We are very pleased to make MammaPrint widely available to U.S. patients and their physicians,” said Bernhard Sixt, CEO and co-founder of Agendia. MammaPrint is a DNA micro array-based in vitro diagnostic laboratory service that measures the activity of 70 genes, providing information about the likelihood of tumor recurrence.

• Lifeline Biotechnologies (Reno, Nevada) said it has recently provided patient cases to Nanyang Technical University to aid in the development of the First Warning System’s (FWS) interpretive analytical system. One objective is to make it more user friendly for women to assist in the detection of breast cancer. Originally, the FWS was worn by women for 48 hours, with eight sensors on each breast. This length of time caused issues because the longer the testing period, the more the likelihood women would accidentally loosen a sensor and send faulty data. After analyzing the patient cases, Lifeline, along with the work at Nanyang Technical University, said it has been working to reduce the testing period to 24 hours or less, which will make it more user friendly for women and increase the accuracy of the FWS.

• Medtronic (Minneapolis) reported FDA clearance of the Reveal DX and Reveal XT, new Insertable Cardiac Monitors (ICMs) that offer diagnostic and monitoring insights to cardiologists managing their patients with syncope (fainting) or abnormal heart rhythms, including ventricular tachyarrhythmias (VT), fast ventricular tachyarrhythmias (FVT), bradyarrhythmias and asystole. The Reveal devices expand on the cardiac monitoring foundation Medtronic began more than 10 years ago with the Reveal and Reveal Plus Insertable Loop Recorders. The Reveal DX will be commercially available in the U.S. next week; the Reveal XT will follow. The Reveal DX continuously monitors the heart’s electrical activity in order to help physicians diagnose whether or not symptoms such as fainting, dizziness and unexplained seizure-like episodes have a cardiovascular cause. Causes of syncope can be heart rhythm disturbances or abnormalities in the structure of the heart. Syncope can lead to serious injury or can be a precursor to sudden cardiac death. About 1.5 million people worldwide suffer from unexplained syncope. In almost 10 percent of patients, syncope has a cardiac cause; in 50%, a non-cardiac cause; and in 40% the cause is unknown. Syncope is difficult to diagnose as syncopal episodes are often too infrequent and unpredictable for detection with conventional monitoring techniques. Placed under the skin of the chest area using local anesthesia during a simple outpatient procedure, the Reveal DX monitor records important cardiac rhythm data to help diagnose the patient so the appropriate treatment can be undertaken. The device, weighing 15 grams, is about the size of a memory stick. Unlike a pacemaker or implantable cardioverter-defibrillator, there are no leads that extend from the device into the heart’s chambers.

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