Continued Risks Of Duodenoscopes Leads FDA To Recommend Disposable Cap Devices
After a study earlier this year found that fixed endcap duodenoscopes continued to pose a significant risk of infecting patients after being washed, the US agency is now urging providers to switch to newer-designed scopes that reduce or eliminate the risk from reprocessing, such as duodenoscopes that have interchangeable caps. The directive from the FDA is good news for Boston Scientific, which makes a disposable duodenoscope that is close to being approved by the agency.
You may also be interested in...
FDA’s Device Center Could Raid $2.8M From Staff Outreach, Training Kitty In 2021 To Fund Other CDRH Needs
While the Trump administration’s proposed fiscal year 2021 budget for the US FDA would give the agency’s device center a 5.3% increase for medtech product approvals and safety, the center’s lofty plans to become the world’s premier regulator of new AI-driven gadgets, next-gen diagnostics and other novel devices means it will have to tap about $2.8m dollars usually set aside for staff training and outreach to help meet its ambitious goals.
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.
Boston Scientific reported higher than expected Q3 results, with growth across emerging markets boosting company revenue. A number of product launches across the business also helped to drive growth.