Regulatory & Reimbursement
FDA Output, November 2024
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in November 2024. Updated November 19.
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Business Strategies
AVS Plans to Crack Vascular Lithotripsy Market With Unique Pressure Wave Tech
Led by Boston Scientific veterans and its technology’s co-inventor, Amplitude Vascular Systems is sponsoring the pivotal trial for a novel intravascular lithotripsy system that it believes will make up ground on Shockwave, the Johnson & Johnson subsidiary that established this billion-dollar market.
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Pathways’ Pick of the Week
Pathways' Pick of the Week: Europe Issues Shortage Reporting Guidance
The EU lays out expectations for a pending mandate to disclose anticipated shortages. Excerpted from Pathways’ Picks October 30 4: EU Shortage Reporting Guide, Upcoming Medicare Rules, and More