A Medical Device Daily

Spiration (Redmond, Washington), a developer of devices for treating severe and chronic conditions of the lung, reported signing an agreement giving Olympus Medical Systems exclusive development and distribution rights in Japan for the IBV Valve System.

Spiration calls the IBV Valve System a minimally invasive treatment "that has diverse applications in both acute and chronic conditions of the lung."

The system is CE-marked for the treatment of diseased and damaged lung, a broad indication that includes the treatment of emphysema and the resolution of prolonged air leaks, which can occur following lung surgery.

The device is currently under investigation in the U.S. as a treatment option for patients with severe emphysema.

Spiration and the companies will collaborate to gain regulatory approval for the IBV system in Japan. Olympus will fund the Japanese clinical trials for the treatment of emphysema and the resolution of prolonged air leaks. Olympus also will file the necessary applications to market the device.

The financial terms of the agreement were not disclosed.

"Olympus, with its strong knowledge of the marketplace in Japan and its status as the world's leading provider of bronchoscopy tools to pulmonologists, is an ideal partner for Spiration," said Rick Shea, president/CEO of Spiration. "We look forward to working together to advancing our therapy in Japan, where we believe our technology will help many people living with the debilitating effects of emphysema."

Spiration and Olympus unveiled an agreement in May granting Olympus exclusive marketing and distribution rights in 43 European countries for the IBV Valve System.

The IBV Valve System is designed to redirect airflow from diseased portions of the lung to healthier areas. During the minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the bronchial tubes through the mouth or nose) to deploy the small umbrella-shaped valves into the airways of the upper lobes of the lungs.

In other agreements:

Health Discovery (Savannah, Georgia), a developer of support vector machine (SVM)-based molecular diagnostics, and DCL Medical Laboratories (Indianapolis), reported an agreement for the development and commercialization of SVM-based computer assisted diagnostic tests for the detection of ovarian, cervical and endometrial cancers.

The new tests will be performed on digital images to assist in providing more accurate diagnoses on biopsy and surgical specimens.

HDC will own the developed intellectual property, and DCL will have a sole use license relating to applications and new mathematical tools developed during the course of this Agreement. The companies will share future service revenues contemplated under the agreement.

The companies said the SVM-based diagnostic imaging systems are expected to improve the sensitivity of detection for endometrial and cervical cancers and significantly improve the specificity of ovarian cancer diagnosis. In addition, images and interpretative data from the new SVM-based systems will be designed for use in web based applications, thus allowing remote review, second opinions and collaborative pathologist interpretation.

HDC says its SVM and FGM pattern recognition tools have application potential in other markets such as oil exploration, financial markets, Internet search and spam, homeland security, and other areas where analysis of large volumes of complex data is required.

DCL is a regional reference laboratory offering services that include specialty testing capabilities in molecular diagnostics.

MedcomSoft (Toronto) said it has been selected by the Maryland Health Care Commission (MHCC) to participate in the Maryland Electronic Health Record (EHR) adoption acceleration program.

MHCC, a state regulatory agency advancing the adoption and utilization of health information technology, in collaboration with the Maryland and District of Columbia medical societies received the first award from the Centers for Medicare & Medicaid Services for the upcoming EHR Demonstration project.

MHCC selected participants from a group of 2007 Certification Commission for Healthcare Information Technology EHR providers.

Rob Wilson, CEO of MedcomSoft, said, "Since MedcomSoft earned the 2007 CCHIT certification, we were in consideration for the MHCC select vendor initiative and one of 23 chosen from the 44 CCHIT-certified vendors."

MedcomSoft develops software solutions for healthcare, using numerically codified point-of-care clinical terminologies to create interoperable electronic medical records.

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