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...
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.,...
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...
China Responds to European Union’s Medical Device Restrictions with Restrictions of its Own
China has imposed restrictions on procurement of European medical devices, following the European Union’s vote to limit Chinese companies from participating in public procurement tenders for medical device contracts last...
FDA Clears Fasikl’s AI-Powered Felix NeuroAI Wristband for Essential Tremor
Fasikl, a neurotechnology company spun out of the University of Minnesota, has received FDA 510(k) clearance for its Felix™ NeuroAI™ Wristband, a noninvasive, AI-driven wearable designed to reduce upper limb...
TELA Bio Launches OviTex Inguinal Reinforced Tissue Matrix in Europe
TELA Bio, Inc. announced on June 3, 2025, the launch of its OviTex Inguinal Reinforced Tissue Matrix in Europe. TELA Bio—which was founded in 2012 and is headquartered in Pennsylvania—is...
European Union Votes to Curb China’s Access to Medical Device Market
The European Union has “agreed overwhelmingly” to limit Chinese medical device manufacturers’ access to public procurement contracts in Europe, Bloomberg reports. On Monday June 2, 2025, European Union (EU) countries...
Bipartisan Law Introduced to Clarify Patent Eligibility
For the past decade, controversy regarding the laws of patent eligibility has created uncertainty in the minds of inventors and investors, especially in the biotechnology, medical diagnostics, and software industries...
FDA Accuses Third Party Testing Labs of Falsifying Data
The Food and Drug Administration (FDA) recently issued General Correspondence Letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories “after discovering data that was falsified or otherwise...
How New U.S. Tariffs Could Reshape Patent Litigation in the Medical Device Industry
As the U.S. imposes sweeping new tariffs on over 180 countries and territories—including a baseline 10% rate and steep increases for China (originally 145%, now reduced to 30% for 90...
Medtech Leaders Speak Out On Impact of Global Tariffs
Some Medtech companies recently addressed the potential impact of global tariffs in their Q1 2025 earnings calls. Johnson & Johnson and Abbott were among the first to speak on the...
U.S. Tariffs and the Medical Device Industry
As of April 24, 2025, the United States has imposed tariffs on over 180 countries and territories. This includes a universal 10% baseline tariff while larger tariffs are in a...
