Tyco to Split into Three
Business Units
The announce-ment by Tyco International Ltd. (Pembroke, Bermuda) that it plans to split into three publicly traded companies has raised concerns among members of the investment community. In particular, analysts have expressed unease over the $40 billion conglomerate's postsplit performance, particularly in regard to reduced earnings and the estimated $1 billion cost associated with the transaction, which is expected to close a year from now.
Boston Scientific Juggling Guidant Deal, FDA Warning
Just hours after Boston Scientific Corp. (Natick, MA) nailed down its $27.2 billion acquisition of Guidant Corp. (Indianapolis), the company learned that, in addition to cleaning up the widely reported product-quality problems at Guidant, it now has to get its own house in order. In a particularly strongly worded warning letter to Boston Scientific, FDA cited “serious regulatory problems” regarding the company's quality management system.
FDA Launches Medical Device Postmarket Safety Initiative
Following what FDA describes as a comprehensive, year-long internal inventory of the tools used to monitor the postmarket safety of medical devices, the agency has announced that it is launching a new “postmarket transformation initiative. The initiative is designed to “better protect the public health by allowing FDA to identify, analyze, and act on problems more quickly, including alerting the public sooner of potential medical device issues.”
Device Companies Lead Midwest Healthcare Investment in 2005
Medical device start-ups in the Midwest reported a greater level of venture investments during 2005 than their counterparts in the biopharmaceutical and healthcare software and service sectors, according to a report released by BioEnterprise (Cleveland). Overall, medtech companies in the region reported $205 million in investments last year, or 37% of the total investments reported for all three sectors.