Renalytix has filed the regulatory submission package with the FDA seeking clearance of KidneyIntelX, and we expect full FDA approval for the KidneyIntelX by year-end 2020. In our view, the risk of protracted FDA review is low given the continuous fine-tuning of the regulatory package in communication with the FDA through the Breakthrough Device designation pathway granted by the FDA in May 2019. The intended use of KidneyIntelX is for patients with Type 2 diabetes and chronic kidney disease.
26 Aug 2020
Final FDA submission filed, approval expected in later in 2020
Sign up to access
Get access to our full offering from over 30 providers
Get access to our full offering from over 30 providers
Final FDA submission filed, approval expected in later in 2020
Renalytix Plc (RENX:LON) | 29.0 0 0.0% | Mkt Cap: 36.6m
- Published:
26 Aug 2020 -
Author:
Edward Thomason -
Pages:
3
Renalytix has filed the regulatory submission package with the FDA seeking clearance of KidneyIntelX, and we expect full FDA approval for the KidneyIntelX by year-end 2020. In our view, the risk of protracted FDA review is low given the continuous fine-tuning of the regulatory package in communication with the FDA through the Breakthrough Device designation pathway granted by the FDA in May 2019. The intended use of KidneyIntelX is for patients with Type 2 diabetes and chronic kidney disease.