Credit agencies Standard & Poor's and Moody's lowered their ratings as promised on Medtronic after it took out a massive debt package to finance its $50 billion acquisition of Covidien.
Here's a look at some of the top regulatory stories for medical device companies this week: Medtronic wins HDE for Enterra II neurostim device; FDA officially clears Integra's Puerto Rico plant; Nevro surges on Senza approvable letter from FDA; mHealth: AliveCor wins CE Mark for new afib algorithm; FDA warns against pediatric use of bone growth proteins
Covidien and Spectranetics close the $30 million deal for the Stellarex drug-eluting balloon, following the close yesterday of Medtronic's $50 billion acquisition of Covidien.
The largest merger in medtech history closes the same day that the Irish High Court sanctions the $49.9 billion union of Medtronic and Covidien.
Medtronic wins a humanitarian device exemption for its Enterra II neurostimulation implant for treating the stomach disorder gastroparesis.
Medtronic (NYSE:MDT) today said it won a humanitarian device exemption for its Enterra II device, a neurostimulation implant designed to treat the stomach disorder gastroparesis.
The FDA warns against using bone-growth proteins in patients under 18 who have bone growth defects, citing the risk of excess bone growth and other potential problems.
The FDA this week warned healthcare providers against using 2 types of bone-growth materials in patients under age 18 who have bone growth defects.
Covidien issues its final quarterly report as a standalone company, saying its fiscal 1st-quarter earnings beat expectations and it prepares for a $43 billion acquisition by Medtronic next week.