‘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.
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2020 Outlook: US Congress Will Address Surprise Billing, Ratify USMCA, Conduct More Medtech Safety Oversight
Congress was able to approve a permanent medical device tax repeal and pass a “LAB Act” bill favorable to the diagnostic industry in 2019. But what device-related legislation is ahead in 2020? Medtech Insight takes a look at some of the medtech bills and draft legislation likely to affect manufacturers pending in late 2019 that are likely to be reviewed – and perhaps approved – in 2020.
The US FDA cleared Pentax Medical’s new duodenoscope as the first in the US with a disposable elevator part that reduces the number of parts needed to be disinfected compared to earlier designs.
Health-care experts are concerned about the potential public risk posed by ethylene oxide emissions but said banning the sterilizing agent without a backup plan is likely to have devastating effects. Recently recorded deaths due to duodenoscope infections has been concerning, but the experts put the blame on inadequate cleaning of the device by staff members rather than on the device itself. The solution, they find, is a better trained workforce.