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‘Right Product, Right Time:’ FDA Clears Boston Scientific's Single-Use Duodenoscope

Amid concerns of infections from duodenoscopes that are not sufficiently re-sterilized, the US FDA has cleared Boston Scientific’s Exalt-D as a the first single-use duodenoscope. Investors expect the device will likely take a significant chunk of the market, especially considering the next competitor is at least a year away.

Exalt Model D
• Source: Source: Boston Scientific

Boston Scientific Corp. has received the first regulatory clearance for a fully disposable duodenoscope meant to prevent deadly infections linked to insufficient cleaning of non-disposable devices.

The US Food and Drug Administration announced on 13 December that it cleared Boston Scientific’s Exalt Model D single-use duodenoscope....

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