NAMSA, the world’s leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, announced today the expansion of its Minneapolis preclinical research laboratory. This expansion will add 55,000 sq. ft. to the current 130,000 sq. ft. preclinical campus in Minneapolis.
In step with the U.S. Food and Drug Administration’s (FDA) commitment to develop a draft revised version of “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” (2005), the agency, on November 3, 2021, has issued draft guidance—“Content of Premarket Submissions for Device Software Functions.”
As cancer has surpassed cardiovascular diseases and is now the leading cause of death worldwide, its conquest remains elusive despite recent notable progress. Cancer remains an incredibly complex disease, involving virtually every tissue in the body and affecting many genes.