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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

FDA Adds 7 New Tools To Its Regulatory Science Toolbox

The US agency has updated its Catalog of Regulatory Science Tools.

FDA Regulation

2 Deaths, 22 Injuries Lead To Class I Recall For Hillrom Overhead Lift

The US FDA has designated a recall of Hillrom’s Liko Multirall 200 Overhead Lift as high-risk class I. The recalled lifts have been manufactured since 2000.

Recalls Safety

Coronavirus Variants Spur FDA To Write New Guidance For COVID-19 Test Developers

The US agency’s immediately-in-effect guidance document – released on 22 February – explains how makers of COVID-19 diagnostics can assess whether their tests are impacted by mutations of the virus.

Guidance Documents FDA

Déjà Vu: Boston Scientific’s Emblem Racks Up Another Class I Recall This Month

The US FDA on 19 February designated a recall of the Emblem S-ICD Subcutaneous Implantable Cardioverter Defibrillator as high-risk class I. The recall comes on the heels of a second, separate class I recall for the Emblem electrode on 2 February.

Recalls Safety

Q4 Recalls Snapshot: Fewer Devices Recalled By Industry, But Software Troubles Still Abound

Problems with software were the No. 1 reason for medical device recalls in the fourth quarter of 2020. Also: Recalls fell by a modest 3%, but the number of recalled device units mushroomed 158%. Check out our Q4 recalls infographic.

Recalls Safety

FDA Inspections All But Stopped In 2020 – But Quality-Related Warning Letters Kept On Coming

The US agency sent 21 of the letters to device makers last year – the same number it mailed to firms in 2019.

Device Warning Letters FDA
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