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August 22, 2025

Application of Safe Harbor Exceptions to the Anti-Kickback Statute

August 20, 2025 | Matt Whitehead On August 7, 2025, the Office of the Inspector General (“OIG”) issued Advisory Opinion 25-09 (“Advisory Opinion”) providing a favorable opinion regarding remuneration to...

August 16, 2025

Recent Machine Learning Studies in Medical Imaging Applying FDA Principles

By Philip M. Nelson Medical imaging is one of the most promising fields for use of AI tools, as pattern recognition and large data sets can enhance human diagnosis (e.g.,...

August 12, 2025

Cardiosense Obtains FDA Clearance For Wearable Cardiac Sensor

By Mark Rubinshtein (August 5, 2025) Cardiovascular disease is a leading cause of death, with over 900,00 deaths reported in the United States in 2023. In this context many companies...

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