The Transitional Coverage for Emerging Technology (TCET) final notice from the Centers for Medicare and Medicaid Services (CMS) doesn’t address the concerns from its draft, leaving the medtech industry to put their hopes behind Congress’s Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691).
TCET Final Notice Leaves Much To Be Desired, Eyes Turn To Congress
The long-awaited TCET final notice doesn’t address major concerns, medtech industry advocates say.

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The General Services Administration’s updated list of “assets identified for accelerated disposition” does not include any buildings at the agency’s headquarters in White Oak, MD after its original list of “non-core” government properties for disposal had more than half the buildings on campus.
Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.
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