Regulatory & Reimbursement
FDA Output January 2023
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in January 2023. Updated January 24.
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Regulatory & Reimbursement
Market Pathways Scorecard: 2022 Roundup
Regulatory & Reimbursement
Pathways’ Picks January 18: DigHealth Payments, MDR Feedback, Medicare Updates, and More
Regulatory & Reimbursement
Pathways’ Picks January 11: Codifying CED, Moving MDR Dates, and More from US, Europe, and Asia
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Investors & Dealmaking
Supermoon Capital: Investing in Sleep
Sleep health is a highly nuanced and highly fragmented field, and though there are dozens of disorders in the category, insomnia and sleep apnea have traditionally been its defining indications. Supermoon Capital, a VC firm entirely dedicated to sleep, is pushing boundaries in both clinical and consumer spaces to elucidate and improve the universal activity that humans do for a third of their lives.
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Regulatory & Reimbursement
Pathways' Pick of the Week: MDR Extension Proposed
The European Commission makes good on its promise to give legacy devices a few more years to transition to the MDR. Excerpted from Pathways' Picks January 11: Pathways’ Picks January 11: Codifying CED, Moving MDR Dates, and More from US, Europe, and Asia.