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FDA clears first 7T magnetic resonance imaging device

October 12, 2017, 7:45 am by FDA US Food & Drug

Today, the U.S. Food and Drug Administration cleared the first seven tesla (7T) magnetic resonance imaging (MRI) device, more than doubling the static magnetic field strength available for use in the United States. The Magentom Terra is the first 7T MRI system cleared for clinical use in the United States.


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More medical news from FDA US Food & Drug

FDA warns Magellan Diagnostics of significant violations of the law as part of investigation into lead testing issues
FDA US Food & Drug : October 23, 2017, 10:48 am
Today the U.S. Food and Drug Administration issued a warning letter to Magellan Diagnostics Inc. for several violations of federal law, including marketing significantly modified versions of two of its blood lead testing systems without the FDA’s required clearance or approval and failing to submit medical device reports to the FDA after becoming aware of customer complaints involving discrepancies in blood lead test results.

Statement by FDA Commissioner Scott Gottlieb, M.D. on medical device manufacturing recovery in Puerto Rico
FDA US Food & Drug : October 20, 2017, 7:19 am
Statement by FDA Commissioner Scott Gottlieb, M.D. on medical device manufacturing recovery in Puerto Rico

FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma
FDA US Food & Drug : October 18, 2017, 2:37 am
The U.S. Food and Drug Administration today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL).

California dietary supplement maker, Custompax prohibited from manufacturing
FDA US Food & Drug : October 13, 2017, 9:14 am
A California dietary supplement manufacturer recently was ordered by a federal court to stop selling its products until the company comes into compliance with the U.S. Food and Drug Administration’s dietary supplement manufacturing regulations and other requirements listed in a consent decree.

Statement by FDA Commissioner Scott Gottlieb, M.D. on Baxter manufacturing recovery in Puerto Rico
FDA US Food & Drug : October 13, 2017, 5:31 am
Statement by FDA Commissioner Scott Gottlieb, M.D. on Baxter manufacturing recovery in Puerto Rico