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Surgical Design Studio Granted Breakthrough Device Designation by US FDA

By June 10, 2019 No Comments

Press Release
Source: Surgical Design Studio

On: Monday 10 June 2019
Companies: Surgical Design Studio

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.

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.”

 

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