The agency rejects the sponsor’s statistical analysis and says there is no statistically significant evidence of efficacy in the U.S. population, and the product seems likely to face a request for another trial from the advisory panel.

Brief summaries of recent product and company developments in the device industry, including the demise of GE's proposed $8 billion acquisition of Abbott Diagnosticss, the Cytyc/Hologic merger, and Alsius' SPAC merger.

What do you get when you cross a women's health company that sells screening and diagnostic imaging technologies to hospitals and radiologists, with a women's health company that sells diagnostics and therapeutic devices to Ob-Gyns? A single company capable of selling goods and services across the entire continuum of care, according to Rob Cascella, president & COO of Hologic, who thus revealed the reasoning behind the $6.5 billion proposed merger of Hologic with Cytyc.

A business development panel representing the emerging group of mid-sized device dealmakers that are actively looking for innovative technology from small companies discusses the current state of medtech dealmaking.