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Q&A: Renalytix AI Prez Explains How MCIT Rule Will Aid Kidney Product Coverage By CMS

 
• By Sue Darcey

Tom McLain tells how the new MCIT policy from the US Medicare agency – and winning support from Congress – will guarantee Medicare coverage for his company’s product, an artificial intelligence-enabled in vitro diagnostic platform.

Kidney disease. 3d illustration.
3D Illustration of kidney disease, the risk for which can be diagnosed through use of Renalytix AI’s new KidneyIntelX artificial intelligence-enabled diagnostic

Release of the final Medicare Coverage of Innovative Technology (MCIT) rule by the US Centers for Medicare and Medicaid Services (CMS) means Renalytix AI’s KidneyIntelX artificial intelligence-enabled in vitro diagnostic platform may be launched soon, company president Tom McLain told Medtech Insight in a 19 January interview.

Released by the CMS on 12 January, the MCIT rule allows instant reimbursement for US Food and Drug Administration breakthrough devices for a period of up to four years. The...

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• By Brian Bossetta

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FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

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• By Amanda Maxwell

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

More from Medtech Insight

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

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• By Marion Webb

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• By Natasha Barrow

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