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In The News

News Major Medicines & Medical Devices Shake-up
08 Jul 2019
News HealthTech Week 2019 recognises industry finalists and winners
04 Jul 2019
News 2019 James & Wells MTANZ Innovation Award and Manufacturing/Export Award Winners announced
03 Jul 2019
News Surgical Design Studio Granted Breakthrough Device Designation by US FDA
20 Jun 2019
News Baxter Healthcare wins 2018 James & Wells MTANZ Innovation Award
20 Jun 2018
News Health Minister sets up expert group to examine system
05 Dec 2017
News Spinal injury leads to award-winning wearable tech
04 Dec 2017
News Device to diagnose melanoma wins James Dyson award
10 Nov 2017
News New surgical device among Velocity $100k Challenge winners
26 Oct 2017
News Ebos takes 14% stake in Australian MedAdvisor
25 Oct 2017
News MTANZ members Fisher & Paykel Healthcare and Pacific Edge feature in TIN awards
18 Oct 2017
News John Ormiston awarded the EuroPCR 2017 Ethica Award
17 Oct 2017
News New Zealand's first robot-assisted knee surgery
05 Oct 2017
News APEC guidance for ethical third-party relationships
18 Sep 2017
News Waikato docs shelve DIY surgery tools
08 Sep 2017
News Call to cut number of DHBs by half
08 Sep 2017
News DIY Doctors
17 Aug 2017
News Orthopaedic surgery crisis looming in New Zealand
17 Aug 2017
News NZ health sector learning to embrace the tech world
02 Aug 2017
News Kiwi doctors swapping stethoscopes for iPads
07 Jul 2017
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Surgical Design Studio Granted Breakthrough Device Designation by US FDA 20 Jun 2019


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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