FDAnews Device Daily Bulletin
July 16, 2012 | Vol. 9 No. 138
As Taiwan and South Korea apply health technology assessment (HTA) to sift out the costs versus benefits of new drugs and medical devices, other Asian countries, such as China, are looking at ways to adopt such cost-cutting programs, a pair of recent industry surveys suggests.
The FDA is developing new methods and laboratory expertise to aid reviewers in identifying potential vulnerabilities and assessing risk mitigation measures for medical software.
The Food and Drug Administration plans to provide medical device makers feedback before they apply for marketing approval to help companies identify regulatory requirements early in the device development process.
Guidelines on how certain mobile medical apps will be governed by the U.S. Food and Drug Administration may be released as soon as the end of the year.
Integrity Life Sciences Receives CE Mark and ISO Certifications for the Integrity Spinal Care System Medical Device
Integrity Life Sciences announced that TÜV SÜD Product Service GmbH of Munich, Germany, issued Integrity the CE Marking and compliance with these requirements is proved within a certified quality management system.
For several years, doctors and medical spas around the country have touted a fat-melting device called the LipoTron 3000, or Lipo-Ex, as a revolutionary way for people to slim down.
B.Braun, an unlisted maker of medical devices, has acquired options to buy a stake of German hospital operator Rhoen-Klinikum, further dimming Fresenius’ chances of taking control of Rhoen.
Derma Sciences Acquires Global Long-Term Exclusive Rights to NIMBUS Technology From Quick-Med Technologies
Derma Sciences and Quick-Med Technologies announced the signing of an agreement whereby Quick-Med Technologies has granted Derma Sciences an exclusive global license to intellectual property related to the novel NIMBUS antimicrobial technology.
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