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FDA Panel Unanimously Supports Berlin Heart's Excor Pediatric VAD

This article was originally published in The Gray Sheet

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Executive Summary

Following strong support from an FDA advisory panel, Berlin Heart is hoping for humanitarian device approval of its Excor Pediatric ventricular assist device within the next six months.

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Berlin Heart’s Excor Pediatric ventricular assist device gains FDA humanitarian device exemption approval. Cerevast Therapeutics gains CE mark for Clotbust ER ultrasound device to treat ischemic strokes. More new products.

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Boston Sci: investment grade

Second EU MDR Notified Body Designated In France

Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.

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Second EU MDR Notified Body Designated In France

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