Baxter will distribute Cellpro's Ceprate stem cell concentration system worldwide pending approval of Nexell's Isolex stem cell collection system under a bankruptcy plan for CellPro.
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“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
Joshi joins the parent company of Citeline, home of Medtech Insight, to focus on AI, business harmonization and long-term growth.
