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Shawn M. Schmitt

Executive Editor

Miami, FL
Executive Editor Shawn M. Schmitt lives and works in Miami. For more than two decades he has written and edited for various high-profile media outlets, including The New Republic and London's Independent Television News (ITN). Since 2005 he has reported on medical device quality control, compliance and post-market issues. A spirited, creative journalist, Shawn reported from the White House Rose Garden for Counseling Today, met with medical device experts in Costa Rica for Medtech Insight, traveled the US to get the scoop on Medicare funding for DecisionHealth, and wrote about the proliferation of nuclear weapons for National Journal's Global Security Newswire. Shawn holds a Master of Arts in Communication: Journalism and Public Affairs from American University in Washington, D.C. (2004), and a Bachelor of Arts in Journalism and Communications from Point Park University in Pittsburgh (1997).

Latest From Shawn M. Schmitt

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Thumbs Up: FDA Authorizes Weight Loss Suturing Systems From Apollo Endosurgery

People with obesity now have new tools to help them lose weight, thanks to the US agency’s de novo authorization.

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FDA Slaps High Risk Class I Label On Recall Of COVID-19 Diagnostics Made In Uncontrolled Plant

More than 160,000 of the tests were recalled, including 104,900 COVID Test Kits Nonsterile and 61,500 Clean Catch Urine Kits.

Recalls Diagnostics

Meet DHCOE Acting Chief Brendan O’Leary, FDA’s New Digital Health Guru

In this revealing interview, the new acting director of the US FDA’s Digital Health Center of Excellence talks about his new role at the DHCOE, the big shoes he’ll have to fill now that former center head Bakul Patel is gone, the need for new regulatory frameworks for digital health – and how he helped repair the Hubble Space Telescope.

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Q&A: FDA Chief Califf Talks Clinical Trial Diversity, Using AI/ML For Inspections, User Fees, And More

The commissioner of the US agency, Robert Califf, answered questions on a variety of timely issues at a 12 July fireside chat. Here are three key takeaways for medtech.

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FDA Releases Plan For Enhancing eMDR Adverse Event Reporting System

The US agency has announced some changes it plans to make to its electronic Medical Device Reporting system over the coming year.

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