United Therapeutics gets FDA green light for lung perfusion device
June 29, 2026
United Therapeutics (Nasdaq:UTHR) announced today that the FDA granted premarket approval (PMA) for its LungFX perfusion device.
United Therapeutics (Nasdaq:UTHR) announced today that the FDA granted premarket approval (PMA) for its LungFX perfusion device.
Bioness Medical announced today that it received FDA 510(k) clearance for its PoNS (portable neuromodulation stimulator) system.
MELBOURNE, Australia, June 29, 2026 /PRNewswire/ — 4DMedical Limited (ASX: 4DX), the global leader in advanced respiratory imaging, today announced that CT:VQ™ technology has Therapeutic Goods Administration (TGA) approval and is included on the Australian Register of Therapeutic Goods (ARTG)—enabling commercial deployment across Australia.
Valgen Medtech announced today that it received CE mark approval for its DragonFly transcathteter mitral repair system.
First Read aims to address interpretation bottlenecks by producing preliminary, high-quality report drafts.
This authorisation will expand the B-Right AI platform’s use to Europe, as BrightHeart continues to roll the technology out across the US.
Cyclana Bio, a biotechnology company pioneering tissue-level approaches to women’s health, has announced it has received Health Research Authority (HRA) and Research Ethics Committee (REC) approval for its 500-patient clinical observational study, PEMP (Predicting Endometriosis Mechanisms and Populations).
Spotlight Medical, a Paris-based oncology diagnostics company, has announced that myStage Dx has received CE marking under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746).
Draeger has received FDA 510(k) clearance to market the latest software update for its Evita V800 ventilator. The version 3.10 software release introduces additional features designed to enhance mechanical ventilation for patients with pulmonary conditions, including acute respiratory distress syndrome (ARDS).
The power-injectable implantable port system is designed to support long-term vascular access in adult and paediatric patients.