A Medical Device Daily

B-K Medical (Herlev, Denmark) has launched the Pro Focus OR ultrasound system, which it says is the only fully featured operating room suite that works as an integrated part of the OR.

The company said the Pro Focus system is designed to be a permanent part of the OR, mounted on the OR boom. The scanner’s flat-screen monitor and control panel are mounted on flexible arms that can be positioned for best use. With the system, BK said, “surgeons can access the ultrasound capabilities they need during surgery quickly and easily.”

It added that because the system is off the floor, “the Pro Focus OR affords the OR staff their accustomed freedom of movement within the sterile area. The system’s simplicity also translates into a reduction in cleaning and preparation time, for quicker turnaround.”

Also setting the Pro Focus OR system apart from more conventional ultrasound systems, the company said, “is that it can accommodate the full range of dedicated surgical transducers. Compatible with the new, high-frequency 8814 intraoperative surgical biplane transducer and 8815 interventional transducer, the scanner provides unprecedented accuracy to interventional intraoperative ultrasound.”

Michael Brock, B-K Medical’s president, said, “The Pro Focus OR is intended to take surgical ultrasound to a new level; it is designed for professionals and the OR of the future. With this system, we are not only able to offer hospitals and clinics the most advanced, dedicated surgical ultrasound system on the market today, but also a cost-effective way to configure and streamline their operating rooms.”

B-K Medical, a subsidiary of Analogic (Peabody, Massachusetts), said it is a “world leader in developing ultrasound scanners designed for surgery and for the investigation of urological disorders.” The product line also includes scanners for other applications, such as gynecological examinations, fetal scanning and radiology.

Firm files responses to UK questions

Biopure (Cambridge, Massachusetts) said it has submitted a complete response to the provisional opinion letter issued by the UK Commission on Human Medicines (CHM) arising out of CHM’s review of Biopure’s application for marketing authorization for Hemopure [hemoglobin glutamer-250 (bovine)].

The indication requested in the response is for the treatment of acutely anemic adult orthopedic surgery patients under 80 when blood is not readily available or not an option.

The company submitted its application to the UK authorities in July 2006 and received a provisional opinion letter in December 2006, which contained the CHM’s questions and requests for additional analyses.

Biopure said it met with the Medicines and Healthcare products Regulatory Agency, the decision-making body, in September 2007 to review its proposed responses to key questions and subsequently finalized the responses.

The company said that once an applicant responds to the commission’s questions, it generally takes four to six months for the agency to make a final determination. If marketing authorization is granted, Biopure could seek registration of the product in other member states in the European Union through the Mutual Recognition Procedure.

Hemopure is approved for sale in South Africa for the treatment of surgical patients who are acutely anemic. In addition to its application in the UK, the company is developing Hemopure for other indications and is supporting the U.S. Navy’s government-funded efforts to develop a potential out-of-hospital trauma indication.

Cambridge NHS Trust adds IT platform

Carefx (Scottsdale, Arizona), creator of what it says is the healthcare IT industry’s only open and scalable information aggregation platform, said that Cambridge University Hospitals NHS Foundation Trust will deploy the company’s Fusion interoperability platform to deliver identity and access management capabilities.

The U.S. firm said the deployment of the Fusion platform “will enable simplified and secure access to a synchronized snapshot of patient data housed in disparate information systems.”

Integrated with Imprivata OneSign Single Sign-On, Fusion will enable 2,000-plus clinicians at the Cambridge-based NHS Trust to access all authorized applications with a single-user ID and password. Carefx said they also will benefit from patient data aligned across multiple applications to provide a complete view of the clinical task at hand ultimately enhancing patient care delivery and clinician satisfaction and efficiency.

Dianne Nixon, head of IT program management at Cambridge University Hospitals, said, “We chose Carefx for a number of reasons. Its solutions are based on an open and scalable architecture, enabling seamless interoperability with our existing IT investments — including our newly deployed single sign-on solution from Imprivata. Additionally, the level of success and satisfaction reported by Carefx clients is truly impressive. I have every reason to believe that the Trust will see a clinical productivity increase of well over 50% with Carefx.”

UK distribution accord for ReBuilder

ReBuilder Medical Technologies (Charlestown, West Virginia) said it has agreed to a joint venture with UFFE Medical (London) to distribute ReBuilder Medical’s home treatment for the skin disease Molluscum contagiosum , which affects primarily children and sometimes presents with hundreds of pimple-like lesions that can take years to resolve if not treated.

Ann-Marie Albertsen, CEO of UFFE Medical, said, “My own daughter contracted Molluscum and after researching what the doctors offered I did some web research that finally led to Dr. Phillips and [ReBuilder]. I ordered the product and it healed my daughter in a week’s time. Many of my neighbors’ children suffer from this highly contagious condition so I decided to see if we could provide representation here in the UK.”

David Phillips, PhD, CEO of ReBuilder, said, “As part of our efforts to reach out to other countries, we are glad to add UFFE Medical to our growing list of distributors overseas. We hope relationships such as these will lead to joint ventures with others to provide assembly and packaging functions in their country as well. This can result in a lower price for the consumer and a lower manufacturing cost for us.”