Briefing · Week 43

News, editorial and the podcast

FDA finalises guidance on predetermined change-control plans for AI devices

Manufacturers can pre-specify model updates without new submissions, within set bounds.

Intelligence & clinical AI22 member comments

Fierce HealthcareYesterday

CMS proposes expanded primary care capitation for 2028

The proposal would extend prospective payment to a wider set of practices.

Systems & policy9 member comments

Rock Health2 days ago

Q3 2026 digital health funding report

Deal count down, average round size up; AI-native companies take the majority of dollars.

Capital & innovation17 member comments