Developing the NESTcc Active Surveillance Portfolio

In 2016, the National Evaluation System for health Technology Coordinating Center (NESTcc) was established, in part, to help address the timely and robust identification of safety signals for medical devices.  NESTcc has received dedicated funding from the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) to advance active surveillance activities […]

NESTcc Seeks Project Manager to Join its Growing Team

NESTcc is growing its team and is seeking a qualified individual to fill the position of Project Manager.  A full description of the Project Manager position can be found here. If your professional experience aligns with the position listed below and if you are interested in helping NESTcc advance its mission to accelerate the development and translation […]

NESTcc Announces First Round of Real-World Evidence Test-Cases

Today, NESTcc announced its first Real-World Evidence Test-Cases.  Initially submitted through a public call for concepts in January 2018, these Test-Cases will answer questions of importance to the medical device ecosystem through collaborations between NESTcc Network Collaborators and participating industry partners.  The eight projects include both 510(k) and premarket approval regulatory pathways, and address devices […]

NESTcc Demonstration Project – VISION: A Better, Faster, Cheaper Method of Device Surveillance

What is VISION?  Stakeholders from every sector stand to benefit from a more complete and efficient method of medical device surveillance.  The Vascular Implant and Interventional Outcomes Network (VISION) is a partnership between the Society for Vascular Surgery Patient Safety Organization (SVS-PSO), the U.S. Food and Drug Administration, and the Medical Device Epidemiology Network (MDEpiNet) […]

Conversation with the NESTcc Governing Committee Member: Bill Hanlon, PhD

“I’ve spent my whole career focused on bringing better products to patients who can benefit from them. Patients aren’t an obscure group of people out there in the world. We’re all patients – ourselves, our families, our friends, our colleagues. So, it’s an honor to be able to bring my experience to the table to […]