FDA Approvals - Pivotal Clinical Data Published For The Only Laser Phototherapy Device
Pivotal Clinical Data Published For The Only Laser Phototherapy Device Cleared By The FDA For Hair Growth (Medical News Today)
Findings of the pivotal clinical trial of the HairMax LaserComb that provided clear evidence of efficacy and safety to the U.S. Food and Drug Administration will be published in the prestigious peer review journal, Clinical Drug Investigation in May 2009.
Pharmaceutical Companies Concerned About FDA's Rules For Google Internet Search Ads (Medical News Today)
Drug industry executives have raised concerns that FDA regulations on Internet search advertisements are unclear and that complying with the rules could make the ads confusing or misleading, the New York Times reports. Search advertisements are brief text ads that appear alongside search results on search engines such as Google (Clifford, New York Times, 4/17).
Thoratec Announces Filing of PMA Seeking Destination Therapy Approval for HeartMate II(R) (PR Newswire via Yahoo! Finance)
Thoratec Corporation , a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that it has filed a PMA supplement with the FDA seeking to add the intended use of Destination Therapy