Washington Roundup
Executive Summary
The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence's "The Gray Sheet."
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MRI For Pacer Patients: Coverage Limited To Studies
CMS has finalized a proposal from last year to cover magnetic resonance imaging scans of patients with pacemaker and defibrillator implants, but only in certain well-controlled studies, while maintaining its MRI coverage restriction for patients with the implants in all other contexts.
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.