A Medical Device Daily
U.S. Department of Health and Human Services Secretary Mike Leavitt said last week that China has granted diplomatic approval for the U.S. FDA to open three inspection offices in China that also will help increase that country's capacity for safe foods, drugs and medical devices.
According to a Reuters report, Leavitt told a briefing during high-level U.S.-China economic talks in Annapolis, Maryland that he hoped to open the offices in Beijing, Shanghai and Guangzhou before year-end, with a total staff of nine to 12 people.
"We are working very closely with the government to create a new strategy on the way we deal with imports," Leavitt said. "We see this office not just necessarily as an inspection group. It will be a capacity-building group."
The news report noted that inspections offices were agreed to in principle last December at the last session of the so-called U.S. strategic economic dialogue, which occurred amid heightened American concerns about the quality and safety of a wide range of imported Chinese foods, drugs and other products.
Leavitt said that during the current round of talks, the FDA and China's quality inspection agency would sign a work plan to tighten food and feed standards. It also has agreed to the terms of a work plan with that country's State Food and Drug Administration, he said, adding that the plans set specific deliverables and deadlines on previous framework agreements announced last December.
Reuters said the two governments also have signed an agreement to work together on traditional Chinese medicines, including a push to improve the scientific basis for such treatments.
Japan okays CyberKnife for added indications
Accuray (Sunnyvale, California) reported that Japan's Ministry of Health, Labor and Welfare (MHLW) has approved the company's CyberKnife robotic radiosurgery system for use in treatment of extracranial tumors, including tumors that move with respiration.
The company said this regulatory approval — which allows use of the CyberKnife System to treat tumors anywhere in the body, including those in the spine, lung, liver, pancreas and prostate — "dramatically expands the types of patients that can be treated with radiosurgery."
Eric Lindquist, SVP and chief marketing officer, said the MHLW regulatory approval for these expanded indications "is a noteworthy milestone for Accuray and significantly expands the potential for the CyberKnife system in Japan."
The CyberKnife is the only robotic radiosurgery system designed to treat tumors anywhere in the body non-invasively. Using continual image-guidance technology and computer-controlled robotic mobility, the system automatically tracks, detects and corrects for tumor and patient movement in real time throughout the treatment.
The system was first approved in Japan in 1996 to treat tumors in the head and neck. There currently are 20 CyberKnife systems installed in that country, making it the second-largest installed base of systems after the U.S.
Accuray recently established an office in Tokyo to better address that market.
Israeli researchers develop hand gesture system
Researchers at Ben-Gurion University of the Negev (BGU; Beer Sheva, Israel) have developed a new hand gesture recognition system, tested at a Washington hospital, that enables doctors to manipulate digital images during medical procedures by motioning instead of touching a screen, keyboard or mouse which compromises sterility and could spread infection, according to a just-released article.
The article, "A Gesture-based Tool for Sterile Browsing of Radiology Images," appears in the June issue of the Journal of the American Medical Informatics Association. It reports on what the authors believe is the first time a hand gesture recognition system was successfully implemented in an actual in vivo neurosurgical brain biopsy. It was tested at the Washington Hospital Center.
Lead researcher Juan Wachs, a recent PhD recipient from the department of industrial engineering and management at the Israeli university, said, "A sterile human-machine interface is of supreme importance because it is the means by which the surgeon controls medical information, avoiding patient contamination, the operating room (OR) and the other surgeons."
Wachs said the Gestix system could replace touch-screens now used in many hospital operating rooms which must be sealed to prevent accumulation or spreading of contaminants and requires smooth surfaces that must be thoroughly cleaned after each procedure but sometimes aren't.
Steen Solution approved in Australia
Vitrolife (Kungsbacka, Sweden) said it has obtained sales approval in Australia for Steen Solution, a solution for functional testing and preservation of lungs outside the body before transplantation.
The Steen technology makes it possible for the first time to test the function of donated lungs outside the body by pumping the solution into the organ's system of vessels before possible use.
With the Steen method, the number of potential organs that can be transplanted increases considerably, VitroLife said. It said that in the U.S., for example, less than 20% of the lungs donated are transplanted today, due to uncertainty about the function of the organ.
The company said that in time, the Steen Solution method can lead to a "fivefold to tenfold increase in the number of lung transplantations carried out." So far, eight transplantations have been performed using this method, all at the University Hospital of Lund.
Vitrolife said it is the market leader within the area of lung preservation solutions with its Perfadex product, with more than 90% of all lung transplantations in the world performed using the product. Perfadex also is part of the new method for functional testing and preservation of lungs outside the body.
Steen Solution already has been approved for sales in Europe, and patents covering the product have so far been approved in Australia and the U.S.
VitroLife said that during 2007, work was done to develop peripheral equipment, such as a box for storage of the lung in order to further facilitate the method using Steen Solution, along with training of a large number of clinics in Europe and the U.S.