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U.S. Sen. Al Franken (D-Minn.) proposed a bill Nov. 15 that aims to promote devices that treat rare diseases, ease conflict-of-interest regulations for approval committees and lift a profit cap on humanitarian use devices. The legislation would bring devices to market faster, he said.
The FDA has released two new draft guidance documents aimed at establishing earlier clinical studies during device development while also clarifying the agencys process for approving clinical trials.
CareFusion has initiated a Class I recall of all EnVe Ventilators manufactured between December 2010 and May 2011, because potential defects could interrupt ventilation to patients.
Siemens Healthcare has released a low-dose information center on the Internet for continuing education and information about dose reduction. Aimed at doctors and clinical personnel, the platform was designed to help keep professionals up-to-date on important factors in radiation reduction in radiology and nuclear medicine, according to Siemens.
In a transaction completed Nov. 7, PerkinElmer purchased Caliper Life Sciences for about $600 million in cash. The Hopkinton, Mass.-based imaging and detection solutions provider will operate within PerkinElmers newly formed Life Sciences & Technology Business entity.
U.S.-based medical device company, Kinetic Concepts will be purchased by a consortium of investment funds advised by Apax Partnerstogether with Canada Pension Plan Investment Board and the Public Sector Pension Investment Boardfor $68.50 per share. The cash acquisition totals approximately $6.3 billion, including KCIs outstanding debt, and is expected to close this November.
3M was ordered to pay $1.3 million to the British Defense Ministry, the Porton Group and Ploughshare Innovation, collectively, after a Nov. 7, U.K. court decision found the company breached a contract by dropping its 2007 acquisition, BacLite. The awarded sum is more than $38 million less than what the trio original sought.
In a performance evaluation, the National Electrical Manufacturers Association found the NanoPET/CT system to be of significant value in preclinical research, according to an article published in the November issue of the Journal of Nuclear Medicine.
Lake Zurich, Ill.-based blood technology company Fenwal initiated a recall of their Blood Component Infusion Set on Oct. 4, due to incorrect labeling.
Medtronic has received an Investigation Device Exemption from the FDA to conduct the first in-home clinical trial of a closed-loop system for Type 1 diabetes management.