Surgical Design Studio Granted Breakthrough Device Designation by US FDA

Surgical Design Studio (SDS), a provider of innovative products for gastrointestinal diseases, today announces its medical devices have been granted Breakthrough Device designation by the United States Food and Drug Administration (FDA).

Surgical Design Studio (SDS), a provider of innovative products for gastrointestinal diseases, today announces its medical devices have been granted Breakthrough Device designation by the United States Food and Drug Administration (FDA).

This appears to be the first time a New Zealand medical device company has been granted entry into the FDA’s Breakthrough Devices regulatory pathway, which is designed to help patients gain more timely access to medical devices that provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

"Congratulations to the team at Surgical Design Studio. To be the first from New Zealand through the FDA Breakthrough devices regulatory pathway is paving the way for others and we are proud to have supported this spin-out through the University of Auckland Inventors Fund."  Will Charles, UniServices’ Commercialisation Executive Director 

Garth Sutherland, CEO of Surgical Design Studio said “this designation validates the importance of the work SDS is doing for patients with intestinal diseases such as bowel cancer and inflammatory bowel disease, and provides us with an opportunity to significantly reduce our time to market for the US.”

About Surgical Design Studio
Surgical Design Studio (SDS) is a privately held medical devices developer based in Auckland, New Zealand, founded in 2017. SDS’s innovative technologies have been spun out from an international centre of research excellence at the Department of Surgery and Auckland Bioengineering Institute, the University of Auckland. The product pipeline SDS is developing has received numerous awards for design excellence and clinical impact. The mission of SDS is to bring transformative products to patients with colorectal cancer and other gastrointestinal diseases, to eliminate complications and improve quality of life.