IntelliGenome, Inc., a molecular diagnostics company advancing next-generation tuberculosis detection technologies, today announced that Colombia’s National Institute for Food and Drug Surveillance (INVIMA) has granted sanitary registration for the CRISPR-TB Blood Test Kit.
Edwards Lifesciences (NYSE:EW) has earned FDA 510(k) clearance for Ecliptis, its left atrial appendage (LAA) exclusion system.
Artivion (NYSE:AORT) announced today that it received FDA premarket approval (PMA) for its AMDS Hybrid Prosthesis 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).