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 intelligence (AI). The...
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 issues...
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
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....
Recent Machine Learning Studies in Medical Imaging Applying FDA Principles
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., by radiologists) or even compete...
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...
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...
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 reportedly voted to ban...
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 implications...
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...
An Alternative for Treating Mitral Regurgitation Receives Support for Ongoing Trial
Mitral regurgitation is the most common form of valvular heart disease and affects around 10% of Americans over 75. It occurs when the mitral valve, which is located between the left...
Zydus Lifesciences in Discussions to Acquire Majority Stake in Amplitude Surgical for €256.8m ($277.4m)
Zydus Lifesciences Limited announced on March 11, 2025, that it entered into an agreement to acquire a majority stake in Amplitude Surgical. Reports state that Zydus Lifesciences has a tender offer agreement with PAI Partners,...
Boston Scientific Agrees to Acquire Sonivie Ltd. For up to $540 Million
Boston Scientific recently announced it entered into a definitive agreement to acquire SoniVie Ltd. According to the press release, SoniVie is a privately held medical device company that developed the TIVUS Intravascular Ultrasound System. SoniVie...
Global Market Size and Technological Advancements for Implantable Medical Devices Continue to Grow
A recent report by Precedence Research estimates the global market size for implantable medical devices will grow from USD 97.62 Billion in 2024 to USD 178.15 Billion by 2034: The rapid increase...
Zimmer Biomet to Acquire Paragon 28
Zimmer Biomet recently announced entering a definitive agreement to acquire all outstanding common shares of Paragon 28. Under the agreement, Zimmer Biomet will pay $13.00 per share, valuing Paragon 28 at approximately $1.1 billion....
Stryker to Spin off Spinal Implants Business
Stryker, one of the world’s largest medtech companies, announced on January 28 that it would be selling its Spinal Implants business to Viscogliosi Brothers, a New York-based, family-owned investment firm founded...
FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development
The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product...
