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Digital Health

FDA selects Dexcom as first TEMPO digital health pilot participant, ushering in a new paradigm of AI-driven chronic disease management

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.

Thomas Müller5 min read
Health Policy

Asia Digital Health Updates: Hong Kong respiratory rate monitoring gets 510(k) clearance, South Korea AI radiology expansion, and Singapore-Vietnam preventive healthcare cooperation.

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.

Marc Dubois4 min read
Digital Health

Why can digital modernization accelerate clinical adoption: Hospital IT upgrades are shifting from “back-end engineering” to “front-end competitiveness”

In recent HIMSS TV discussions, doctors at Samsung Medical Center emphasized that if healthcare systems position infrastructure modernization as an effort to improve the clinical experience rather than as a mere IT project, they are more likely to gain physician support and drive the adoption of new technologies. This approach is reshaping the procurement logic for Digital Health, Healthcare Technology, and AI Healthcare.

Elena Richter6 min read
AI Healthcare

GE HealthCare doubles down on nuclear medicine: How AI, radiopharmaceuticals, and imaging platforms are reshaping precision medicine infrastructure

GE HealthCare will showcase AI software, imaging systems, radiopharmaceuticals, and localized production solutions related to nuclear medicine during SNMMI 2026, reflecting that nuclear medicine is moving from competition among single devices toward a phase of expansion driven by “platformization + ecosystemization.”

Sophia Rossi8 min read