A Diagnostics & Imaging Week

Aurora Imaging Technology (North Andover, Massachusetts), manufacturer of the Aurora 1.5T Dedicated Breast MRI System, said it has achieved CE marking and quality system certifications for the device, as well as Canadian approval of the system.

The Aurora System with Bilateral RODEO (Rotating Delivery of Excitation Off-Resonance) is designed to be located within breast care centers. The company said the system "is ideal for a wide range of indications in breast disease management," including:

  • Detection of cancer in higher-risk women, especially those with dense breast tissue or for whom mammography is technically limited due to anatomic factors, such as surgical alteration or implants.
  • Determining the extent of cancer for better treatment planning.
  • Evaluation of patients to determine if there are positive surgical margins indicating residual cancer.
  • Monitoring cancer response in patients being given neoadjuvant chemotherapy.
  • Evaluation of breast implant integrity. The company said the RODEO technology "suppresses fat and normal ductal tissue, [combining] easily with silicone-suppression sequences, allowing both implant integrity assessment and cancer detection in both breasts in a single MRI examination."

"With a growing international demand for a complete breast MRI solution, we have many partners awaiting this certification," said President and CEO Olivia Cheng. Adding that centers without the Aurora system "provide breast MRI on traditional whole-body scanners that require accessory products from a variety of manufacturers that are poorly interfaced and often difficult to use," she said, "breast radiologists now have a truly integrated breast MRI solution."

Royal Hospitals, Philips in 15-year deal

The Royal Hospitals (Belfast, Northern Ireland) organization has signed a deal worth more than EUR 173 million with Royal Philips Electronics (Amsterdam, the Netherlands) to provide, maintain and replace medical equipment for monitoring, diagnosing and treating patients over the next 15 years.

William McKee, chief executive of Royal Hospitals, and Jouko Karvinen, CEO of Philips Medical Systems, discussed the contract, which will cover equipment in operating theaters, critical care and a new imaging center due to be ready for use in 2007.

"This is a significant milestone in the modernization of services at The Royal Hospitals," said McKee. "It's a good deal for us as service providers – and a good deal for patients, who can be assured that equipment vital to their diagnosis and treatment is future-proofed and patient-friendly."

The Managed Equipment Service element of the contract will ensure that downtime due to equipment failure is minimized and that medical equipment will be replaced in line with agreed cycles based on Royal College clinical guidance and incorporating technological advances.

Karvinen said the equipment and services alliance "symbolizes the future changes in healthcare, as outsourcing and partner-sharing models will increase patient benefits."

The service officially begins in October.

Askion to produce device for EOS

Electro-Optical Sciences (EOS; Irvington, New York), a company focused on designing and developing a non-invasive, point-of-care instrument to assist in the early diagnosis of melanoma, said it has entered into an agreement with Askion (Gera, Germany) for the production of EOS's MelaFind hand-held imaging device.

The agreement calls for Askion to produce MelaFind imaging devices for EOS to be used in the company's pivotal trial, which is expected to be conducted at more than 20 clinical study sites in the U.S. The purpose of the pivotal trial is to establish the safety and efficacy of MelaFind in the imaging of suspicious skin lesions.

Financial terms of the agreement were not disclosed.

"This agreement is an important milestone for EOS and is a significant step in our precommercialization process," said Joseph Gulfo, president and CEO. "2006 will be an exciting year for EOS as we conduct our clinical trials and anticipate PMA approval and commercialization of MelaFind in 2007."

Gerald Wagner, PhD, acting chief operating officer and member of EOS's board of directors, said, "I have had first-hand dealings with Askion management and personnel for 15 years since my days at Bayer Diagnostics and Agfa. Askion has a solid reputation for top-quality production and manufacturing."

EOS started as a part of Agfa-Gevaert AG in 1991, mostly with employees from the former Carl Zeiss Jena.

The MelaFind product features a hand-held imaging device that emits multiple wavelengths of light to capture images of suspicious pigmented skin lesions and extract data. The data are then analyzed against EOS's database of melanomas and benign lesions in order to provide information to the physician and produce a recommendation of whether the lesion should be biopsied.

CTLM results featured at Arab Health

Imaging Diagnostic Systems (IDSI; Fort Lauderdale, Florida) included reports on an array of computed tomography (CT) laser breast imaging clinical results during last week's Arab Health 2006 conference in Dubai, United Arab Emirates. The company presented clinical cases compared to mammography, ultrasound and MRI from a number of sites where its CT Laser Mammography (CTLM) technology is used.

Janusz Ostrowski, vice president of international sales, said of IDSI's involvement in the event: "Through our attendance, we are reinforcing the clinical value of CTLM breast exams to women in the Middle East and supporting our customers in the region."

Arab Health is the largest healthcare exhibition in the Middle East, with upwards of 28,000 attendees.

The CTLM system is the first breast imaging system that uses laser technology and patented algorithms to create 3-D cross-sectional images of the breast. The non-invasive examination that does not expose the patient to radiation or require breast compression.

Imaging Diagnostic Systems has received CE marking of the system, along with approval in Canada and China. It is seeking FDA premarket approval for use of CTLM as an adjunct to mammography.

MSI cites sales activity in China, UAE

Medical Services International (MSI: Edmonton, Alberta) said it has signed an agreement to start shipping VScan test kits into Anhui Province in China. MSI said the accord with a private hospital in the providence covers its test kits for HIV, hepatitis B & C and tuberculosis.

Based on discussions with officials from the hospital, the company said it anticipates that the hospital will require a minimum of 500,000 to 600,000 test kits per year.

MSI also reported that its distributors on site at the Arab Health 2006 conference in the United Arab Emirates had been busy taking orders for VScan products.

Lifeline gets Chinese MastaScope order

Lifeline Biotechnologies (Reno, Nevada) said it has received a $27,000 purchase order for the MastaScope from its Chinese distributor, Shanghai Science Medical Equipment Co.

"This order is the result of what has been a concerted sales effort by Shanghai Science Medical Equipment in introducing the MastaScope to physicians, hospitals and clinics throughout China. We are expecting an increase in orders throughout 2006," said Jim Holmes, CEO of Lifeline Biotechnologies.

Shanghai Science Medical Equipment has sales representation in 17 of China's 26 provinces. The MastaScope received approval from Chinese regulatory authorities last year.

Distributor named for Chembio in Tanzania

Chembio Diagnostics (Medford, New York) said it has named Anudha Ltd. to distribute the company's rapid HIV tests in Tanzania. Chembio, whose HIV Stat-Pak Dipstick is part of the national testing protocol in Uganda, established a regional office in Tanzania in June 2005 led by Dr. Jay Drosin.

The company said it believes there will be "a significant scale-up in the demand for rapid HIV tests in Tanzania and other countries in the region that have been ravaged by AIDS."

Tanzania is one of 50 countries worldwide that is part of the Clinton HIV/AIDS Initiative Procurement Consortium. Chembio said it was recently selected by the Clinton HIV/AIDS Initiative as one of four global suppliers to those countries.

No Comments