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Boston Scientific’s Breakthrough-designated EXALT Model D Single-Use Duodenoscope, the first single-use scope of its kind, recently received FDA clearance and is among the first devices to receive transitional pass-through payment status from CMS under a new pathway announced earlier this year.
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The one-year postponement of the European Medical Device Regulation is being whittled away by travel and social distancing restrictions and the EU’s current refusal to allow remote audits for initial MDR certifications. Industry is pushing for greater acceptance of virtual visits as a necessity in this time.
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Boston Scientific’s Breakthrough-designated EXALT Model D Single-Use Duodenoscope, the first single-use scope of its kind, recently received FDA clearance and is among the first devices to receive transitional pass-through payment status from CMS under a new pathway announced earlier this year.
Subscribe now to read the full analysis