Living Innovation Blog
A blog about important topics for medical device and healthcare innovators.
You and the FDA: Medical Device Applications for Pre-Submission Review
In our latest article, Ximedica's Regulatory and Human Research Affairs Lead, Kimberly Waller, Ph.D., explains how FDA pre-submissions minimize difficult, time-consuming questions from the FDA after submitting your marketing application.
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Posted on Oct 12, 2018
Lab-On-A-Chip: Tomorrow's Diagnostic Technologies Today
Select Bio’s Lab-on-a-Chip and Microfluidics World Congress was an exciting conference this year, with Ximedica’s Paul Fleming (PhD, Program Director in Diagnostics) presenting on stage. The conference covered a broad array of emerging technologies including low-cost diagnostics in global health, real-time personal monitoring, and nanosensors for single-molecule sequencing. Dr. Fleming’s technical presentation offered product development insights for assay automation, inviting the audience to think about novel ways of automating their process while the assay is still in development.
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Posted on Oct 09, 2018