Regulatory & Reimbursement
FDA Output, July 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in July 2026. Updated July 9.
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 to Watch
Urologic Health: Noninvasive Bladder Function Testing Removes Diagnostic Barriers in Urology
Today’s catheter-based system for urodynamic testing is often uncomfortable and painful, such that it’s almost a last resort, even though it’s the only tool clinicians have for accurately diagnosing and treating the causes of lower urinary tract symptoms. Urologic Health aims to burst that bottleneck with a new, noninvasive modality for urodynamic testing.
Don't Just Advertise... Strategize!
Advertise with MedTech Strategist and be seen by medtech's most influential executives.
Learn More
Regulatory & Reimbursement
End of-Inpatient Only Rule Impacts Medtech Commercial Strategies
Medicare’s phased-in elimination of the inpatient only rule and simultaneous expansion of the list of procedures it covers in ambulatory surgery centers are forcing medical device manufacturers to rethink where and how much they get paid.