Application of Safe Harbor Exceptions to the Anti-kickback Statute
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 physicians with an ownership interest in a medical device manufacturer....
U.S. Design “Rocket Docket” Grounded
The U.S. Patent Office’s program for expedited examination of design applications under 37 CFR 1.155 (often called the design “rocket docket”), which was suspended earlier this year, was formally canceled...
Cardiosense Obtains FDA Clearance for Wearable Cardiac Sensor
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 have pursued products to help diagnose...