MedTech News
.................... by Andrew Celentano
IntelliGenome Receives INVIMA Approval for CRISPR-TB Blood Test
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 picks up FDA nod for left atrial appendage clip
Edwards Lifesciences (NYSE:EW) has earned FDA 510(k) clearance for Ecliptis, its left atrial appendage (LAA) exclusion system.
Artivion earns FDA nod for aortic arch prosthesis device
Artivion (NYSE:AORT) announced today that it received FDA premarket approval (PMA) for its AMDS Hybrid Prosthesis device.
United Therapeutics gets FDA green light for lung perfusion device
United Therapeutics (Nasdaq:UTHR) announced today that the FDA granted premarket approval (PMA) for its LungFX perfusion device.
Bioness wins FDA clearance for portable neurostimulator for stroke recovery
Bioness Medical announced today that it received FDA 510(k) clearance for its PoNS (portable neuromodulation stimulator) system.
Scientists uncover how ovarian cancer resists chemotherapy—and how to reverse it
Michigan State University researchers have identified how ovarian cancer cells become resistant to chemotherapy and discovered a protein that, when blocked, can restore the drug’s effectiveness.
4DMedical Receives TGA Approval for CT:VQ™, Bringing Non-Contrast Ventilation-Perfusion Imaging to Australia
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 earns CE mark for mitral valve repair system
Valgen Medtech announced today that it received CE mark approval for its DragonFly transcathteter mitral repair system.