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Surmodics announces regulatory delay for its SurVeil balloon
The FDA noted more information on biocompatibility and labeling is needed.

January 19, 2023 By Danielle Kirsh

The FDA has indicated that Surmodics’ Surveil drug-coated balloon premarket approval application is not approvable.

According to an FDA letter to the company, Surmodics’ Surveil was not approved due to certain information in the biocompatibility and labeling categories. The governing agency said more information needs to be added by an amendment to Surmodics’ PMA application to place it in an approvable form.

Needham analyst Mike Matson said in an email that company management anticipated approval in the first quarter of 2023 to trigger a $27 million milestone payment from Abbott, $25 million of which would be considered revenue.

Get the full story on our sister site, Medical Tubing + Extrusion.

About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at dkirsh@wtwhmedia.com.