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Regulation, reimbursement, privacy, public procurement and policy decisions shaping MedTech adoption.
How to Identify AI Washing in Medical Technology M&A? Key Difficulties in Due Diligence of Digital Health AI Assets and Analysis of New FDA Regulations, Covering CDS Guidelines, NAMs, and Clinical Trial Innovation.
From the US FDA to the EU AI Act, major global markets are accelerating the development of regulatory frameworks for AI medical devices. This article reviews regulatory policies, academic research, and industrial impacts from 2015 to 2025.
Based on a systematic review of global AI medical device regulation and research from 2015 to 2025, this paper analyzes the regulatory pathways of the United States, the European Union, China, Japan, and South Korea, and explores how policies affect the medical technology industry.
This article reviews the regulatory evolution of AI medical devices in the United States, the European Union, China, Japan, and South Korea from 2015 to 2025, and analyzes its impact on the Digital Health and Medical Devices industries.
In early 2026, the U.S. FDA updated its general health and clinical decision support guidance, expanding the scope of low-risk digital health products, and plans to streamline software-related guidance while introducing a new AI framework, with far-reaching implications for the industry.
Global digital therapeutics and AI medical device regulation are accelerating, with FDA and NMPA approval numbers hitting record highs and the industry facing new compliance challenges. This article analyzes regulatory strategies, clinical evidence, and market impact.
From FDA to the EU AI Act: A Decade of Evolution and Industry Impact of AI Medical Device Regulatory Policies Across the World's Five Major Economies.
Deep Analysis of the Ten-Year Evolution of Global AI Medical Device Regulatory Policies, Covering the United States, the European Union, China, Japan, and South Korea, Revealing Industry Challenges and Future Trends.
The U.S. FDA has selected Dexcom as the first participant in the TEMPO digital health device pilot. The AI-driven blood glucose management program will be granted exemption from certain premarket approval requirements, while collecting real-world data through Medicare.
XRHealth acquires digital therapeutics company Swing Therapeutics, integrating the FDA De Novo-authorized Stanza fibromyalgia treatment with its virtual clinic to build a cross-device XR chronic pain management platform, and achieving comprehensive reimbursement through Medicare and commercial insurance.
Analyze the event of Veradigm being sued for patient portal data tracking, and explore the challenges and industry impacts of medical technology companies in data sharing and privacy compliance.
In the third quarter of 2026, the FDA will make approval decisions on multiple biotechnology products, involving areas such as IgA nephropathy, mRNA influenza vaccines, Duchenne muscular dystrophy cell therapy, and gene therapy. These decisions will profoundly impact the direction of the medical technology industry.
PanopticAI obtains FDA's second 510(k) for contactless respiratory rate monitoring; Coreline Soft partners with Mint Medical to advance lung cancer screening AI in Germany; AIRS Medical receives strategic investment to accelerate MRI innovation; QuantumTX and Kaopiz join forces to develop AI-driven preventive healthcare solutions.
China's "Regulations on the Clinical Research and Translational Application of Biomedical New Technologies" (Order 818) establishes a new commercialization pathway for advanced therapies such as cell and gene therapy, allowing clinical translation and charging fees in tertiary hospitals without drug registration from the National Medical Products Administration. This signals China's intention to accelerate local innovation and standardize the drug development environment, and it is expected to become an important player in the development and manufacturing of advanced therapies.
Adcentrx Therapeutics announced that its ADC drug ADRX-0405 has received IND approval from China's NMPA and will be included in Chinese clinical centers to conduct global Phase 1a/1b trials targeting advanced solid tumors, especially prostate cancer. This article analyzes the significance of this technology to the medical industry, market impact, and future outlook.
Amgen is making additional investments in Puerto Rico to expand its biologics manufacturing network, while BioNTech is shutting down some factories in Germany and Singapore and cutting jobs. The different choices made by the two companies reflect how biopharmaceutical manufacturing is shifting from pandemic-driven expansion toward supply chain resilience, capacity efficiency, and a reconfiguration of pipeline priorities.