Bioretec has submitted a market authorization request for its bioresorbable RemeOs™ magnesium screw in the US – QNT Press Release


Bioretec Ltd Company Announcement 5 May 2022 at 9.00 am EEST

HELSINKI, May 5, 2022 /PRNewswire/ —

INSIDE INFORMATION

Bioretec Ltd, a pioneer in bioresorbable orthopedic implants, has submitted a De Novo request for market authorization in the United States for the RemeOs™ trauma screw based on bioresorbable magnesium alloy. Bioretec estimates the market authorization in the United States to be granted during the second half of 2022. The previously communicated estimate was in the first half of 2022.

The De Novo request provides a registration pathway for novel medical devices for which there is no predicate device available in the US market. In spring 2021, the US Food and Drug Administration (FDA) granted the RemeOs™ trauma screw a Breakthrough Device Designation status, demonstrating that the product represents breakthrough technology and offers significant advantages over existing approved products. The submission of the De Novo market authorization application has been preceded …

Full story available on Benzinga.com



Source link

Recommended For You

About the Author: News Center