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Clinical Update (10/2006)

Executive Summary

Short summaries of notable clinical findings impacting the device industry: blood test may detect early-stage lung cancer; new device may help regrow teeth.

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Lung Cancer: An Up and Coming Device Market

Lung cancer is the number one cause of deaths from cancer, in large part because it generally isn't detected until very late stages. At that point, survival rates are low and the only option is radical lung surgery. But now imaging technologies can detect smaller cancers, sooner, and in the wake of the publication of the Early Lung Cancer Action Project, the medical device industry is preparing for a paradigm shift. Start-ups are now developing technologies to remove the barriers in diagnosis and access that hinder therapeutic intervention.

Lung Cancer: An Up and Coming Device Market

Lung cancer is the number one cause of deaths from cancer, in large part because it generally isn't detected until very late stages. At that point, survival rates are low and the only option is radical lung surgery. But now imaging technologies can detect smaller cancers, sooner, and in the wake of the publication of the Early Lung Cancer Action Project, the medical device industry is preparing for a paradigm shift. Start-ups are now developing technologies to remove the barriers in diagnosis and access that hinder therapeutic intervention.

Nothing Random About It: The State of Cancer Drug Development at FDA

FDA is getting tougher on cancer drug approvals. But stakeholders on all sides-industry, regulators, and patient groups-say that's probably a good thing. Under the leadership of Richard Pazdur, MD, the controversial director of FDA's newly formed Office of Oncology Drug Products, the agency is raising the bar for getting cancer drugs on the market.

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