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7 medtech stories we missed this week: Sept. 8, 2017

September 8, 2017 By Danielle Kirsh Leave a Comment

From BrainScope’s pediatric traumatic brain injury assessment device to EOS Imaging releasing new surgery planning software, here are seven medtech stories we missed this week but thought were still worth a mention. 1. BrainScope to develop pediatric traumatic brain injury assessment device BrainScope announced in a Sept. 7 press release that it will immediately start creating […]

Filed Under: 510(k), Cardiovascular, Clinical Trials, Diagnostics, Digital Health, Food & Drug Administration (FDA), Imaging, Neurological, Regulatory/Compliance, Research & Development, Spine, Structural Heart Tagged With: AliveCor, Bonesupport, BrainScope Company Inc., C4 Imaging, Delphinus Medical Technologies Inc., Eos Imaging, Skyline Medical

C4 Imaging’s 1st FDA win is for MRI marker

December 10, 2013 By Chris Walker Leave a Comment

C4 Imaging lands FDA clearance for MRI marker

C4 Imaging won clearance from the FDA for its 1st product, the Sirius Positive Signal MRI marker, designed for use following the treatment of prostate cancer with brachytherapy.

The MRI marker is designed to facilitate seed localization within the prostate, utilizing a single post-implant MRI procedure.

Brachytherapy involves implanting around 100 radioactive seeds into the prostate. It has risen in popularity because the treatment is considered more effective and convenient, according to the press release.

Filed Under: Food & Drug Administration (FDA), Imaging, News Well, Regulatory/Compliance Tagged With: C4 Imaging, Prostate

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