Ostroff: Program Alignment Moving Ahead
The FDA’s program alignment will see district offices and laboratories focus only on one product category, primarily designated by geographic location and the types of industries that surround those locations, according to FDA Acting Commissioner Stephen Ostroff. This will ensure better coordination of regulatory activities between the field and headquarters, and is a major step toward specialization of investigators, field offices and their laboratories, Ostroff said last week during the keynote address at the RAPS Regulatory Convergence Conference in Baltimore, Md. The planning phase is largely complete and the agency hopes to move into the implementation phase over the next year or two.
Sinocare Group to Acquire Nipro Unit
Changsha, China-based Sinocare Group has reached an agreement to acquire Nipro Diagnostics, a wholly owned subsidiary of Nipro Corp., a company headquartered in Osaka, Japan, for about U.S. $273 million in cash. Fort Lauderdale, Fla.-based Nipro Diagnostics’ portfolio consists of advanced performance products for people with diabetes, including blood glucose monitoring supplies and technologies. Sinocare, founded in 2002, markets blood glucose monitoring systems in the Chinese market. The transaction is expected to be completed in 90 days.
Cellvizio Cleared for Surgerical Indication
The FDA has given its blessing to Paris-based Mauna Kea Technologies’ Cellvizio, a confocal laser endomicroscopy platform, for use in surgeries to identify cancerous tissue. Cellvizio will provide clinicians with a real-time microscopic image of tissue during a surgical procedure to guide treatment. In a statement, company founder and CEO Sacha Loiseau said the technology will enhance surgical precision. The technology is being evaluated in several major clinical studies in the surgical treatment of cancer.
Vermillion Scores CE Mark for Overa Test
Austin, Texas-based Vermillion has received CE mark for its Overa test, which detects risk of malignancy for ovarian cancer. Overa, the next-generation version of the company’s OVA1, is a blood test assessing whether a woman with an ovarian adnexal mass is at high or low risk of malignancy. A study of Overa demonstrated specificity of 69 percent, a 28 percent improvement over the first generation test. It also showed an improvement in positive predictive value from 31 percent in OVA1 to 40 percent in Overa.
Edwards, CareFusion Study Interoperability
Edwards Lifesciences and BD’s CareFusion unit are teaming up to enable interoperability between patient hemodynamic management and IV fluid administration. Specifically, the two will examine the impact of hydration on outcomes for moderate- to high-risk surgical patients using Edwards’ advanced hemodynamic monitoring systems and fluid management algorithms and CareFusion’s Alaris infusion systems. Specific terms of the agreement were not disclosed.