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Breakthrough Devices would no longer enjoy a fast track to Medicare inpatient new technology add-on payments (NTAPs) and outpatient pass-through payments under a proposal from CMS. If finalized, the change would likely lead to a massive drop of new awards from the bonus payment programs that have grown in recent years.
An update on a company bringing localized, immediate, and beam-free radiotherapy to brain cancer patients.
The number of MDR submissions and certificates is trending up. Excerpted from Pathways’ Picks April 1: AI Act Deemphasized, MDR Numbers, Generative AI Approval, and More.