Spotlight On: It’s Raining AI Devices as Regulatory Storm Reshapes Digital Health

AI-enabled medical devices; digital health regulation 2025; FDA AI draft guidance; EU AI Act health; generative AI in healthcare; SaMD regulation; clinical oversight of AI; AI accountability in healthcare; digital mental health devices

J&J-backed Cellular Origins raises $40M for cell therapy manufacturing

Cellular Origins; Johnson & Johnson; Series A; $40 million; cell therapy manufacturing; Constellation platform; robotic automation; ATMP; TTP Group; scalable manufacturing

Kymera’s oral “Dupixent-in-a-pill” KT-621 shows strong early eczema results

Kymera Therapeutics; KT-621; Dupixent-in-a-pill; oral STAT6 degrader; atopic dermatitis; eczema; BroADen Phase 1b trial; Dupixent rival; Type 2 inflammation; early clinical data

MediView Achieves First CE Mark, Bringing Augmented Reality to European Healthcare

MediView; CE Mark; augmented reality; European healthcare; mixed reality; clinical visualization; MediView XR; MediView XR90; GE Healthcare; interventional radiology

Recent Advances in AI & Multi-Omics for Translational Research

AI-driven multi-omics integration; translational research; precision medicine; biomarker discovery; patient stratification; machine learning; foundation models; agentic AI; cancer research; drug response prediction

Researchers Advance Toward Matching Patients with the Most Effective GLP-1 Drug for Personalized Obesity Treatment

GLP-1; precision medicine; obesity; drug response prediction; genetic test; personalized care; side effects; machine learning; MyPhenome; Mayo Clinic; treatment adherence

Inhibikase Therapeutics Announces Pricing of $100 Million Public Offering of Common Stock and Pre-Funded Warrants

Inhibikase Therapeutics; public offering; common stock; pre-funded warrants; $100 million; Jefferies; BofA Securities; Cantor; clinical-stage pharmaceutical; pricing