Angela Silva

Angela Silva

Morgan Lewis

Contact
View Bio
RSS

Latest Posts › FDA Approval

Share:

How the Health Tech Investment Act Could Reshape Medicare Reimbursement for Algorithm-Based Services

As AI transforms medicine, some of the most promising healthcare innovations are at risk of exclusion by Medicare’s outdated and complex reimbursement structures. The Health Tech Investment Act, or S. 1399, introduced in...more

5/27/2025  /  Algorithms , Artificial Intelligence , Centers for Medicare & Medicaid Services (CMS) , Digital Health , FDA Approval , Health Technology , Medical Devices , Medicare , Proposed Legislation , Reimbursements

When Words of Encouragement May Indicate More: Congress Focuses on Rare Disease Approval Process

While many provisions of the FY 2023 Consolidated Appropriations Act (Omnibus) have received much attention, one has flown under the radar. In its explanatory statement on the Omnibus, the US Congress indicated that it is...more

2/22/2023  /  FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Orphan Drugs , Pharmaceutical Industry , Prescription Drugs

FDA Proposes Framework for Transitioning COVID-Related Medical Devices from EUA/Enforcement Discretion to Permanent Marketing...

In two draft companion guidance documents, the US Food and Drug Administration (FDA) establishes a proposed framework for transitioning medical devices currently marketed under emergency use authorization (EUA) or enforcement...more

1/19/2022  /  Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Medical Supplies , Pharmaceutical Industry
3 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide