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In November 2021, the Centers for Medicare & Medicaid Services (CMS) rescinded a short-lived program to expedite national Medicare coverage for innovative devices amid safety concerns...
On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) released a Notice with Comment Period (Notice) proposing a new Transitional Coverage for Emerging Technologies...
The SNOO is the first sleep product to earn FDA De Novo approval for safely keeping babies on their backs while they sleep. Back sleeping significantly lowers the risk of SIDS, according to experts.
From the blog of Lili Eylon at The Times of Israel
The U.S. Food and Drug Administration (FDA) recently issued the draft guidance “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health...