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Renalytix announced on Friday that the US Food and Drug Administration (FDA) had granted De Novo marketing authorisation for its ‘KidneyIntelX.dkd’ prognostic test.
In November 2021, the Centers for Medicare & Medicaid Services (CMS) rescinded a short-lived program to expedite national Medicare coverage for innovative devices amid safety concerns...
VALENCIA, Calif., June 29, 2023 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company leading the development...
SEOUL, Korea, June 28, 2023 (GLOBE NEWSWIRE) -- Kalos Medical Inc. (“Kalos Medical”), a developer of innovative medical devices treating hypertension and other chronic illnesses, announced on June 23rd that
On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) released a Notice with Comment Period (Notice) proposing a new Transitional Coverage for Emerging Technologies...