The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence's "The Gray Sheet."
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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.
Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus.
France's ANSES warns women using oral contraceptives not to use a supplement marketed by UK firm Hairburst after linking the product's consumption to two cases of severe acute hepatitis.