FDA Output
FDA Output, October 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in October 2026. Updated October 31.
Welcome to MyStrategist
Quickly uncover the breadth and depth of the editorial offerings found only in MedTech Strategist and Market Pathways – the medtech industry’s leading sources of global business, regulatory, and reimbursement analysis and intelligence on an all-in-one, digital platform. Think Strategically. Subscribe Today
Start a free trial and unlock 5-days of exclusive subscriber-only access to MedTech Strategist & Market Pathways
Start Trial
Start-Ups
LIOM: A Window Into Biomarkers and Health
LIOM is developing a wearable that can in real time noninvasively sense glucose and other molecules to help people—consumers, patients, researchers, and clinicians—make connections between biomarkers, behavior, and health.
Don't Just Advertise... Strategize!
Advertise with MedTech Strategist and be seen by medtech's most influential executives.
Learn More
Pathways’ Pick of the Week
Pathways' Pick of the Week: FDA Plans First GenAI Guidance
FDA drafts mental health generative AI guidance. Excerpted from Pathways Picks October 7: AI Plans in the UK and US, Europe’s First JCA Devices, and More.