A Medical Device Daily
Medicsight's (London) majority owned Japanese subsidiary, Medicsight KK (Tokyo), said it plans to initiate eight clinical studies in that country, jointly sponsored by the Japan National Cancer Center. The company said those clinical studies represent "a major step forward" in its plans to determine the performance of its ColonCAD and LungCAD software for Japanese patient groups.
"Medicsight is committed to ensuring our software is compatible with Japanese populations and is easy for Japanese radiologists to utilize," said David Sumner, Medicsight Asia CEO. "These studies will concentrate on showing how computer-aided detection (CAD) can benefit radiologists in interpreting time-consuming and difficult-to-read studies such as CT colonography and identifying lesions in the lung, such as nodules."
Sumner said this is the first time that such a series has taken place in Japan, "and we believe that it will further drive the adoption of CAD as being essential when reading these types of studies."
Medicsight's CAD tools are designed to be seamlessly integrated into either 3-D workstations or picture archiving and communications systems to assist radiologists in the identification of lesions found in the lung and polyps found in the colon. The company said that by utilizing a "concurrent-read" approach, Medicsight CAD allows radiologists to review the original images simultaneously with regions of interest generated by CAD.
Medicsight ColonCAD is an image-analysis software tool designed to be used with CT colonography (virtual colonoscopy) to assist radiologists in detecting and measuring potential colorectal polyps. The company said the product has been developed using one of the world's largest CT scan databases and is the first concurrent-read CAD software available for CT colonography.
Medicsight LungCAD is a medical imaging software tool designed to assist radiologists in the evaluation of pulmonary nodules on CT scans of the lung. The product, which also uses a concurrent-read approach, is intended to assist radiologists in detecting lesions in the lung, such as nodules, while providing information to the radiologist to assess patient images more effectively.
Aussie ortho firm has eye on China
Portland Orthopaedics (Sydney, Australia) said it has initiated registration of its complete line of orthopedic products with the State Drug Administration of China (SFDA) in a process expected to take 12 months.
The company has begun the process of identifying and appointing specialist Chinese local distributors. It said it has signed on a consulting firm with a "proven track record in the area of orthopedic products in China" to assist in the process.
Portland Orthopaedics said it has conducted exploratory work in Asia, notably in Korea and Japan, and has a range of products particularly suited to the Asian market. It said its DTC Asian series hip replacement prosthesis is "ideally suited" to the typically narrower femur of the Asian anatomy.
David Sekel, the company's managing director, said the process is rigorous, but Portland is confident that there should be no setbacks. "Our past achievements with regulatory approvals in other markets shows that we are well aware of the diligent approach required and we have internal quality processes in place to satisfy the particular demands of regulatory bodies," he said.
The company's products have been sold in Australia, the U.S., Israel and Europe. It said entry into the Asian market will be a "significant milestone."
MedAire to sell Asian Global Doctor clinics
MedAire (Tempe, Arizona) said it has entered into a definitive agreement to sell its network of Global Doctor clinics in Asia to its country manager for Global Doctor in China, David Wong, who has formed Global Health Care Pty Ltd., based in Perth, Australia.
The parties said they expect the deal to close within 60 days.
"The change represents a major opportunity for the Global Doctor clinics," said MedAire Chairman and CEO Joan Sullivan Garrett. "We were just not in a position to provide the capital and management time needed to move Global Doctor to a level of sustained operating excellence and profitability. Mr. Wong has the vision, passion and funding to do that."
Under the new ownership, Global Doctor clinics in China will be establishing a formal relationship with a major network of hospitals in China, providing clients with a full range of quality healthcare services.
MedAire acquired the Global Doctor network in January 2003. There currently are eight Global Doctor clinics in the network, six located in China, one in Bangkok, Thailand, and the other in Jakarta, Indonesia.
As part of the deal, MedAire has negotiated a preferred provider agreement with Global Health Care giving MedAire clients continued preferred access to Global Doctor clinics. MedAire also will continue to partner with Global Doctor clinics to assist with logistical coordination of medical evacuations from the region.
MedAire provides emergency medical and security assistance services for companies with employees, customers or guests in remote environments. Its clients include commercial airlines, corporate flight departments, maritime operators and government agencies.
China adds 100 Quantum Sniffers
Implant Sciences (Wakefield, Massachusetts), a manufacturer of products for national security, medicine and industry, said it completed the shipment of more than 100 units of its Quantum Sniffer hand-held explosives detection equipment ordered by the China Railway Administration during the company's second quarter, which ended on Dec. 31. Additional units of the equipment have been ordered by various law enforcement and other agencies in China and are expected to be shipped this month.
The Quantum Sniffer equipment has now been shipped for use in numerous countries, including China, Greece, Pakistan, Italy, South Korea, Kuwait, Dubai, United Arab Emirates, Australia, the UK and the U.S. The Quantum Sniffer was developed for use in the detection of trace residues of explosives materials for aviation and transportation security, protection of high threat facilities, infrastructure, customs and border protection, and cargo screening.
In addition to its explosives detection equipment, Implant Sciences manufactures radioactive products for the treatment of cancer, including sales of radioactive seeds for the treatment of prostate cancer and development of a new, FDA-approved radioactive source for use in the treatment of breast cancer.