A Diagnostics & Imaging Week
NeoMatrix (Irvine, California) said it has received CE-mark approval for European commercial sales of its HALO Pap Test for the Breast. The company also has received regulatory approval in Brazil to commercialize HALO, and the first order was shipped to that country recently.
The HALO test is a 5-minute, noninvasive test performed with a device that delivers a combination of warmth, massage, and vacuum in order to collect nipple aspirate fluid — which can then be examined to identify women who are at high risk of developing breast cancer.
The company said the HALO Breast Pap Test is the first fully automated, noninvasive breast disease-screening device designed for use in the primary care setting.
"We are pleased to receive the CE mark and are excited about our business prospects in Europe where, as in the U.S., breast cancer remains a major health problem. In fact, breast cancer is the primary cause of cancer deaths in women worldwide," said COO Matt Heindel.
He said the company is "evaluating" several distribution opportunities and expects to initiate European sales later this year
Regarding the beginning of sales in Brazil, Heindel said, "There has been excellent local organization preparing for the launch of HALO in Brazil, [which] has a great reputation for healthcare. There has been significant interest in screening and prevention of breast cancer, both of which rely on identifying the high-risk population."
He added that several other countries are in various stages of the registration process and "we look forward to bringing HALO to women all over the world in the near future."
Many breast cancer experts believe that identifying high-risk women is the key to reducing the incidence and death rate from the disease. "Currently, most women diagnosed with breast cancer have no known risk factors," NeoMatrix said. "The previous inability to identify those most likely to develop the disease has made it difficult to apply proven preventative treatments, and may result in late detection of the disease, reducing a woman's chance of a cure and making treatment options more invasive."
The company said that over the past 18 months since HALO was launched in the U.S., about 35,000 tests have been performed. "In addition to the many women identified as high risk who were previously unaware of this fact, HALO testing has also led to discovery of early-stage breast cancer in patients who had been routinely screened by other methods," NeoMatrix said.
HALO is not a replacement for routine screening with breast exams and mammograms, which are designed to identify lesions and typically find tumors after they have been growing for eight to 10 years, according to the company. "Rather, HALO is an adjunct to these methods with a different objective: to find women at high risk in order to facilitate prevention and/or early detection when the disease is still 100% curable."
The company said HALO is further indicated in younger women who are not good candidates for mammography because of dense breast tissue that can obscure the detection of lesions by X-ray.
GE unveils products in Malaysia
GE Healthcare Information Technologies (Milwaukee, Wisconsin) used the HIMSS Asia Pac conference in Kuala Lumpur, Malaysia, as a launching point for a new suite of Centricity solutions targeted for hospitals and outpatient imaging centers.
The company also released Centricity PACS Web Diagnostic (WebDX), a new web-based diagnostic viewer application that is tightly integrated to Centricity RIS/ PACS, which bring comprehensive detailed patient history to a single patient folder.
Building on Centricity's business process and advanced clinical capabilities, the new Centricity suite provides what GE Healthcare termed "the robust, web-based accessibility of IntegradWeb solutions through the acquisition from Dynamic Imaging."
The Centricity PACS-IW Solutions for hospitals will offer web-based portability, instantaneous image reporting and scalable business processes, GE said. "This single-desktop solution will drive practice efficiency, productivity for the radiologist and immediate results access for the referring physician by fostering a more collaborative approach to patient care and provider partnerships, thus driving better patient care and business practices in an increasingly competitive market," the company said in its announcement
Centricity PACS IW allows a radiologist to view images on any PC with regular monitors, but for diagnosis purposes, GE said it recommends Barco's (Kuurne, Belgium/Sacramento, California) Coronis 6MP monitors, "due to their impressive image quality, [and] accuracy . . . offering two screens together with equal luminance, automatic calibration and broad usability."
Building on existing enterprise connectivity and comprehensive infrastructure of Centricity PACS, Centricity PACS WebDX provides an enterprise-wide archive, using EMC storage technology, for access to any type of image in one complete platform, GE said. Centricity PACS seamlessly integrates with RIS and EMR solutions to reduce paper.
Leksell Perfexion in first Japanese use
Elekta (Stockholm, Sweden) said Leksell Gamma Knife Perfexion, its new system for stereotactic radiosurgery, has been used for the first time in Japan to treat patients at the Jiro Suzuki Memorial Gamma House of Furukawa Seiryo Hospital (Miyagi).
The company said the 100-bed hospital has a strong neurosurgery program, and is the first in Japan to offer treatment with Leksell Gamma Knife Perfexion, an advanced radiosurgery treatment system for intracranial stereotactic radiosurgery or Gamma Knife surgery.
Leksell Gamma Knife is in daily use in more than 50 centers in Japan and Furukawa Seiryo Hospital currently utilizes Gamma Knife surgery to treat about 500 patients each year.
French center using Hi•Art system
TomoTherapy (Madison, Wisconsin) said that Centre Oscar Lambret (Lille, France) has begun treating cancer patients using the TomoTherapy Hi•Art treatment system, a CT platform-based radiotherapy solution for improved cancer care.
This is the first of two Hi•Art treatment systems that Centre Oscar Lambret has ordered. The second system will be installed later in 2009.
The decision by Centre Oscar Lambret to adopt TomoTherapy's technology follows calls for research proposals launched by the French national cancer institute, INCA, in July 2005 to promote implementation of image-guided radiotherapy technology that was not previously available in France.
To date, six centers in France have adopted TomoTherapy's solution, including: Institut Curie (Paris), Institut Bergonié (Bordeaux), Centre Paul Strauss (Strasbourg), Centre René Gauducheau (Saint Herblain) and Institut Claudius Regaud (Toulouse).
French system signs Hutchinson accord
Hutchinson Technology (Hutchinson, Minnesota) said it has signed a two-year tender authorizing it to sell its InSpectra StO2 Tissue Oxygenation Monitoring System to the 37 French hospitals belonging to the Assistance Publique Hopitaux De Paris (AP-HP), a healthcare system that admits more than one million emergency patients per year.
The company said InSpectra StO2 is a new vital sign with "broad applications" for critical-care medicine.
The InSpectra StO2 System for tissue oxygenation monitoring helps clinicians reduce risks and costs by enabling faster and more precise assessment of oxygen delivery to vital organs and tissue. The system provides continuous information using near-infrared spectroscopy and a noninvasive, single-use sensor placed on the thenar eminence (thumb muscle).
During shock, the body reduces blood flow to peripheral muscles and core organs (liver, gut and kidneys) in order to preserve oxygenation of the brain and heart. By measuring tissue oxygenation in the peripheral thenar muscle, the InSpectra StO2 System uses the body's own response mechanism to provide information on the adequacy of oxygen delivery to these vital organs.