Share Prices & Company Research

Market News

15 Mar 2021 | 08:55

Renalytix AI confident despite delay to new US Medicare rule

(Sharecast News) - Artificial intelligence (AI) diagnostics company Renalytix AI updated the market on the establishment of the 'Medicare Coverage of Innovative Technology' (MCIT) pathway on Monday, reporting a 60-day delay to its implementation. The AIM-traded firm said MCIT was intended to provide a coverage pathway for Medicare beneficiaries across the United States for innovative medical devices and diagnostic tests designated under the 'Breakthrough Device' review programme and with market authorization by the Food and Drug Administration (FDA).

It said the Centers for Medicare and Medicaid Services (CMS) was delaying the implementation date of the MCIT rule by 60 days, beginning a 30-day comment period to solicit additional public feedback on the rule.

Renalytix AI said it expected the MCIT rule, as is or amended, would become effective within the expected 2021 FDA review and clearance period for its 'KidneyIntelX' product, and would have "no material effect" on its business plan.

"Renalytix AI's lead product, KidneyIntelX, was granted FDA breakthrough designation in May 2019 and submitted its final FDA application in August 2020," the board said in its statement.

"The MCIT rule has bipartisan support in Congress and is considered by many as a key programme to drive medical innovation and improve countless lives."

At 0833 GMT, shares in Renalytix AI were down 5.79% at 1,008p.
Get in touch today
Join Redmayne Bentley
Talk to us now about opening a new account or transferring your account from another provider
0113 243 6941
Get in touch today
Contact your local office
Contact your local office to find out more
The value of your investments and the income from them may go down as well as up, and you could get back less than you invested.
Continuing our Personal Service: View our Latest COVID-19 Update: 14th May 2021
We use cookies on this site to improve your experience and help us provide you with a better website. An explanation of the cookies we use and their purpose can be found within our Cookie Policy. Your continued use of this site means you consent to the use of cookies.