Medical Device Network

First patient dosed in GE HealthCare’s Phase II/III LUMINA clinical trial

GE HealthCare has dosed the first patient in its Phase II/III LUMINA clinical trial for the investigational manganese-based MRI contrast agent, mangaciclanol.
Medical Device Network

FDA and CMS outline new Medicare coverage pathway for medical device access

The agencies’ initiative is intended to speed up the processes involved in medical devices’ securing Medicare coverage once approved by the FDA.
Medical Device Network

Edwards Lifesciences raises FY26 guidance following strong Q1

Edwards Lifesciences revealed that its Q1 2026 performance was better than expected, prompting it to uplift its previous FY26 outlook.
Medical Device Network

Imricor begins US commercial sales of NorthStar mapping system

Imricor will present the NorthStar mapping system at the Heart Rhythm Society’s Annual Scientific Sessions in Chicago. Credit: Imricor. Imricor Medical Systems has started commercial distribution of ...