RCTs, real-world evidence, and the science behind digital treatments.
Policy & Regulation
The joint FDA-CMS pilot ties regulatory evaluation to real-world outcomes and Medicare coverage - and Dexcom's AI-driven Glucose H…
Policy & Regulation
The proposed rule adds five telehealth codes, overhauls remote monitoring billing, and floats a 'Software as a Medical Service' ca…
Digital Therapeutics
The FDA-CMS pilot lets prescribers administer DTx products before clearance, with real-world data feeding both the clearance decis…
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