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Kidney disease diagnostics group Renalytix AI said the implementation date had been delayed in the US for medicare coverage of innovative medical devices.
The Centers for Medicare & Medicaid Services would delay implementation of the Medicare Coverage of Innovative Technology (MCIT) rule by 60 days, beginning a 30-day comment period for additional public feedback.
'RenalytixAI expects the MCIT rule, as is or amended, will become effective within the expected 2021 FDA review and clearance period for KidneyIntelX and will have no material effect on the RenalytixAI business plan,' the company said.
RenalytixAI's lead product, KidneyIntelX, was granted FDA breakthrough designation in May 2019 and submitted its final FDA application in August 2020.
The company noted that the MCIT rule had bipartisan support in Congress and was considered by many as a key program to drive medical innovation and improve countless lives.
At 9:00am: (LON:RENX) Renalytix Ai PLC share price was 0p at 436p