Two watchdogs, one playbook. On 14 January 2026, the European Medicines Agency and the U.S. FDA jointly published “Guiding principles of good AI practice in drug development,” a concise set of 10 rules for using AI across the medicines lifecycle, from data collection and model building to post-market monitoring. It’s not a binding guidance, but…
A deep dive into the EU Commission’s latest findings on AI in healthcare. What MedTech founders and investors need to know in 2025.
The EU wants to be the global leader in AI and in medical technology. Unfortunately, its own flagship regulations are on a collision course. Europe’s innovators are stuck in the middle. One year after the EU AI Act entered into force, the continent’s medtech trade body MedTech Europe is calling for a four-year delay in…
FAQ #10: How Can AI and Machine Learning Enhance Omnichannel Marketing? AI and machine learning represent transformative technologies that enable sophisticated personalization, predictive analytics, and automation capabilities essential for effective omnichannel marketing at scale. These technologies address the complexity and data volume challenges inherent in integrated multi-channel campaigns.1 AI-Powered Personalization at Scale Dynamic Content Customization leverages machine learning…
What is MLR and why does it matter in pharma and MedTech marketing? MLR stands for Medical, Legal and Regulatory review. It is a mandatory, cross-functional process that ensures that all promotional, educational and informational materials are: In highly regulated industries like pharmaceuticals and MedTech, MLR approval is a critical checkpoint before any HCP-facing or…
What are the main forms of generative AI being leveraged in pharma marketing? Generative AI can be categorized into three general uses: What are the primary use cases for AI in pharma and MedTech marketing? There are four broad categories of AI use cases in pharma and MedTech marketing:
What is Artificial Intelligence (AI) in a pharma commercial context? In a pharma commercial context, AI primarily refers to generative AI, which differs from traditional “classical AI” or machine learning. In pharma, generative AI is used for activities like writing marketing materials, generating webinars, building image and video libraries, spotting segmentation opportunities, and speeding up…
Do you know that FDA already approved 521 Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices? PAPNET. The failure of the pioneering AI/ML-enabled test. Five hundred apps may not surprise you in January 2023, given the noise around Open AI and its GPTChat. However, the first such device, PAPNET Testing System, was approved over 28…
Deprexis – Digital therapeutics (DTx) for depression has received DiGA fast-track approval for DTx prescription and reimbursement in Germany. The innovative DiGA process allows for fast-track approval of digital therapeutics and is the first such program in the world. It was created by the 2019 Digital Healthcare Act and allows apps to be prescribed by…
Coronavirus COVID-19 (NCov-2019) has tested some of the digital health capabilities such as AI-based predicitive models and real-time big data visualization. As a positive side effect, it has also allowed public to learn about epidemiology via video games. AI-based predictive models caught COVID-19 faster than us According to the news reports, two AI-based and…