Breakthrough Device designation for KidneyIntelX™, the company’s AI-enabled test for fast-progressing chronic kidney disease (CKD), represents a major positive for the investment case. Benefits include priority review, senior FDA management engagement and regulatory review team support, which could result in an earlier than expected commercial launch (currently 2021e). In addition, it raises competitive barriers as Breakthrough Designation would not be open to potential future products with the ....
02 May 2019
Breakthrough Device designation granted by the FDA
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Breakthrough Device designation granted by the FDA
Renalytix Plc (RENX:LON) | 35.0 0 0.0% | Mkt Cap: 35.0m
- Published:
02 May 2019 -
Author:
Jens Lindqvist -
Pages:
3
Breakthrough Device designation for KidneyIntelX™, the company’s AI-enabled test for fast-progressing chronic kidney disease (CKD), represents a major positive for the investment case. Benefits include priority review, senior FDA management engagement and regulatory review team support, which could result in an earlier than expected commercial launch (currently 2021e). In addition, it raises competitive barriers as Breakthrough Designation would not be open to potential future products with the ....