Source: The Insides Company Limited
On: Monday 10 June 2019 – Auckland
Companies: The Insides Company Limited
The Insides Company (Insides Co.), a provider of innovative products for patients with intestinal failure, announces its medical devices have been granted the Breakthrough Device Designation by the United States Food and Drug Administration (FDA).
The Insides Company appears to be the first New Zealand medical device company to achieve this designation. This regulatory pathway is designed to improve ease-of-access for patients who need medical devices to treat or diagnose life-threatening diseases.
Garth Sutherland, CEO of The Insides Company, said, “This designation validates the importance of the work Insides Co. is doing for patients with intestinal diseases. This new status allows us to reduce our time to market in the US significantly.”