MOUNTAIN VIEW, Calif., Feb 2 (Bernama-GLOBE NEWSWIRE) -- Vascular
Dynamics, Inc., (VDI) a privately held medical device company developing
novel solutions for the treatment of hypertension, today announces that
the United States Food and Drug Administration (FDA) has approved the
company’s application to participate in the Expedited Access Pathway
(EAP) program for its MobiusHD® device for the treatment of resistant
hypertension.
VDI was also one of only nine companies chosen for the FDA’s Early Feasibility Study Investigational Device Exemptions (IDE) Pilot Program, in 2012. The Pilot Program enables companies to conduct smaller-scale studies under the guidance of the Agency in the United States in order to meet the requirements for an earlier pathway toward approval.
http://mrem.bernama.com/viewsm.php?idm=28378
VDI was also one of only nine companies chosen for the FDA’s Early Feasibility Study Investigational Device Exemptions (IDE) Pilot Program, in 2012. The Pilot Program enables companies to conduct smaller-scale studies under the guidance of the Agency in the United States in order to meet the requirements for an earlier pathway toward approval.
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