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According to the latest report from Precedence Research, the global digital health market size is expected to grow from $420.08 billion in 2025 to $1.171 trillion by 2035, with a CAGR of 10.8%. AI, telemedicine, and wearable devices are driving the wave of healthcare digitalization, with Europe leading the global market.
In 2026, the biotech and life sciences field reaches a critical turning point. AI and machine learning become R&D infrastructure, gene editing, synthetic biology, and microbiome therapies move toward clinical application, and global regulatory frameworks are being rapidly restructured. This article outlines 26 major trends, analyzing how technology, markets, capital, and policy are reshaping the healthcare innovation ecosystem.
The U.S. FDA has announced that Dexcom is the first participant in its TEMPO Digital Health Pilot Program, which allows certain digital health devices to be exempt from premarket review while collecting real-world data through Medicare. Dexcom plans to use AI and continuous glucose monitoring technology to screen for prediabetes and type 2 diabetes, marking a deep integration of regulatory innovation and payment reform.
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.
2026 US Digital Health Laws and Regulations Update, covering digital health technology, data use and sharing, and analysis of impacts on medical technology companies, hospitals, and investors.
Deloitte's latest research shows that diagnostic manufacturers are shifting from traditional product suppliers to a B2B2C model, with AI, EHR workflow integration, and interoperability becoming key to the next stage of growth.