Shareholders on Tuesday approved Medtronic's proposed $43 billion merger with Covidien, which is set to close by early next month. The move came a few hours after a similar announcement from Covidien's shareholders. The deal is still awaiting approval from the High Court of Ireland.
A plan by New Zealand and Australia to create a single agency to regulate the medical device sector in both countries has been dropped after a review of the costs and progress of the plan. Australia's Therapeutic Goods Administration and New Zealand's Medicines and Medical Devices Safety Authority will continue to oversee their respective markets separately.
Covidien has received 510(k) clearance from the FDA to market its Nellcor respiration device, which features version 1.0 software and a respiratory sensor for adults. The company plans a limited U.S. launch of the device next month.
The Japanese Ministry of Health, Labor and Welfare has approved St. Jude Medical's Eon Mini neurostimulator system. The rechargeable device electrically stimulates the spinal cord to treat chronic pain of the limbs or trunk as well as pain associated with failed back procedures.