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medtechintelligence
3 天
No Longer “Forever Chemicals”
Because of the environmental and health risks that PFAS ─ per- and polyfluoroalkyl substances ─ pose, they are subject to a ...
medtechintelligence
3 天
AI and Automation Tools: Medical Writers’ Point of View
EU MDR and IVDR have created many new challenges for medical writing and regulatory affairs professionals. An increased ...
medtechintelligence
3 天
Trump Picks RFK Jr. as Health Secretary. What can the MedTech expect?
Could MedTech find itself as the collateral damage if an RFK Jr. run HHS “goes wild” with FDA regulation of pharma and ...
medtechintelligence
4 天
Navigating the Medicare Maze: How Innovative Technology is Modernizing Benefits ...
In the face of sweeping Medicare changes for 2025, millions of seniors face the challenge of navigating a complex landscape ...
medtechintelligence
15 天
J&J MedTech Receives FDA Approval for Pulsed Field Ablation Platform for AFib Treatment
The VARIPULSE™ Platform is the first and only Pulsed Field Ablation (PFA) System in the U.S. fully integrated with the CARTO™ ...
medtechintelligence
3 天
Quality/Regulatory
As laboratories navigate the evolving landscape of Laboratory Developed Tests (LDTs), the FDA’s phased approach to regulation marks a significant shift. This blog outlines what these new regulations ...
medtechintelligence
15 天
Trinity Biotech Regains Compliance with Nasdaq Listing Requirements
Trinity received written notice from the Nasdaq Stock Market LLC (“Nasdaq”) confirming that the Company has regained ...
medtechintelligence
15 天
Sanofi adopts platform to handle multiple National Regulatory Authority submission
With numerous planned submissions underway for 2024, the new platform is setting a new standard for managing simultaneous ...
medtechintelligence
15 天
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