How to Measure Performance for AI-enabled Medical Devices? FDA Seeks Public Input
On September 30, 2025, the U.S. Food and Drug Administration (FDA ) posted a Request for Public Comment regarding how to measure the performance of medical devices enabled with artificial...
The FDA Drops New Laboratory Test Regulations
Laboratory-developed tests (“LDTs”) are in vitro diagnostic (“IVDs”) products designed and used within a single clinical laboratory to perform high complexity testing. These tests can identify a wide range of...
Keeping Up with AI: FDA Issues Guidance on Predetermined Change Control Plans (PCCPs) for Artificial Intelligence (AI)-enabled Devices
On August 18, 2025, the Food and Drug Administration (FDA) issued guidance (Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions) to provide recommendations...
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...
