Notice Concerning Media Reports on Our Duodenoscope in the U.S.

Media in the U.S. and other countries have reported that an OLYMPUS duodenoscope, specifically model TJFQ180V, has been marketed in the U.S. since 2010 without a 510(k) clearance by the U.S. Food and Drug Administration (FDA) for sale to hospitals and other licensed medical facilities.

Olympus Medical Systems Corporation (OMSC) made a decision, based upon FDA policy, that a modification to our previously FDA cleared duodenoscope did not require a new 510(k) application to FDA prior to marketing the modified duodenoscope in the U.S. in 2010.

As a medical device manufacturer, we remain committed to serving people worldwide by contributing in a meaningful and positive way to the healthcare environment, working in each country to adhere strictly to local regulations, follow sound business practices and conduct our business according to society's expectations.

Virtual Clinical Trials Summit

Virtual Clinical Trials Summit: The Premier Educational Event Focused on Decentralized Clinical Trials

In this virtual environment, we will look at current and future trends for ongoing virtual trials, diving into the many ways companies can improve patient engagement and trial behavior to enhance retention with a focus on emerging technology and harmonized data access across the clinical trial system.