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Constitutional Challenges Medical Devices Healthcare

A&O Shearman

Italian Medical Device Payback: Italy approves 75% reduction on medical device payback to end disputes

A&O Shearman on

Background: The Payback Mechanism and Its Impact - Italy’s payback system for medical devices has been a source of significant upheaval in the sector, with both domestic and international companies closely monitoring...more

Jones Day

Judge Blocks FDA Regulation of Laboratory-Developed Tests

Jones Day on

On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - July 2018 #2

Robinson & Cole LLP on

We have previously reported on the ongoing cybersecurity issues with St. Jude defibrillators [view related posts here, here, and here]. On June 29, 2018, the Food and Drug Administration (FDA) classified the required firmware...more

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