What Every STI Test Developer Should Know About FDA Clinical Trials Posted on May 5, 2025 (May 6, 2025) […] Read More… from What Every STI Test Developer Should Know About FDA Clinical Trials
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Everything Changes, Yet It’s Still the Same: The LDT Ruling and Its Implications for Laboratories Posted on April 17, 2025 (April 17, 2025) […] Read More… from Everything Changes, Yet It’s Still the Same: The LDT Ruling and Its Implications for Laboratories
What the HHS Reorganization Means for Diagnostics and Why Strategic Partnerships Matter Now More Than Ever Posted on April 11, 2025 (April 11, 2025) […] Read More… from What the HHS Reorganization Means for Diagnostics and Why Strategic Partnerships Matter Now More Than Ever
The Case for Chromogenic Agar in the Age of MALDI-TOF MS Posted on March 10, 2025 […] Read More… from The Case for Chromogenic Agar in the Age of MALDI-TOF MS
Risk Management Guidance for Medical Devices Incorporating Machine Learning (ML) or Artificial Intelligence (AI) Posted on March 6, 2025 […] Read More… from Risk Management Guidance for Medical Devices Incorporating Machine Learning (ML) or Artificial Intelligence (AI)
From Concept to Market: How the FDA’s Breakthrough Device Designation Works Posted on March 3, 2025 (March 4, 2025) […] Read More… from From Concept to Market: How the FDA’s Breakthrough Device Designation Works
The Value of Internal Quality Audits Posted on February 9, 2025 (February 9, 2025) […] Read More… from The Value of Internal Quality Audits
Key Points from the Nov 2024 FDA IVD Roundtable Posted on November 19, 2024 (November 22, 2024) […] Read More… from Key Points from the Nov 2024 FDA IVD Roundtable
