Breakthrough Device Designation

Wednesday, September 8th, 2021 1:00pm to 2:00pm
: Online
Registration required

CNY Biotech Accelerator, Upstate Medical University presents

Breakthrough Device Designation

Bryan S. Margulies, MS, PhD, CSO and Cofounder, Zetagen Therapeutics
Visiting Professor of Biology & Bio-Imaging, University of Notre Dame
Adjunct Associate Professor of Pathology, SUNY Upstate Medical University

Dr. Margulies will explain how Zetagen Therapeutics’ technology met the eligibility for FDA’s Breakthrough Devices Program and will discuss the process and benefits of the program.

What is the FDA Breakthrough Devices Program?
Per FDA, the Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.  The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.  Learn more about the Breakthrough Devices Program principles and features in Sections II and IV of the Breakthrough Devices Program final guidance and FDA website:

Our speaker, Brian S. Margulies, MS, PhD, was formerly an assistant professor of orthopedics, cell biology and pharmacology at SUNY-Upstate. His research focuses on stem cell modulation to promote bone formation in all practice areas including bone sarcoma. He obtained his PhD, MS and BS in bioengineering from Syracuse University and trained at the University of Pennsylvania in the College of Veterinary Medicine. While Bryan was achieving his BS, MS & PhD and working with Upstate Orthopedics Research, he also trained in and with Cornell Pathology and Veterinary Departments. Dr. Margulies was an NIH NRSA Fellow, a Mazess Student Fellow and has over 25 publications.