RUA Life Sciences has announced a short delay to the filing of its 510(k) application to the FDA for its large bore vascular graft product. The delay is due to the unexplained presence of non-toxic cellulose found during the analysis of leachable extracts from tested graft samples. Significantly, results from the more important tests (eg in vivo animal tests) were all positive. RUA will undertake additional graft testing, resulting in the delay to filing, to ensure the submission is as strong as ....
25 Jun 2021
cenkos: RUA Life Sciences Plc -- Vascular graft update
Sign up to access
Get access to our full offering from over 30 providers
Get access to our full offering from over 30 providers
cenkos: RUA Life Sciences Plc -- Vascular graft update
RUA Life Sciences Plc (RUA:LON) | 11.5 0 0.0% | Mkt Cap: 7.14m
- Published:
25 Jun 2021 -
Author:
Chris Donnellan -
Pages:
5
RUA Life Sciences has announced a short delay to the filing of its 510(k) application to the FDA for its large bore vascular graft product. The delay is due to the unexplained presence of non-toxic cellulose found during the analysis of leachable extracts from tested graft samples. Significantly, results from the more important tests (eg in vivo animal tests) were all positive. RUA will undertake additional graft testing, resulting in the delay to filing, to ensure the submission is as strong as ....