WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA panel backs GRAIL's Galleri on a 6 to 4 effectiveness vote TriSalus clears TriNav Advance, its fourth pressure-enabled infusion device Anaconda Biomed raises $56M to finish a 327-patient stroke trial FDA issues an early alert on Impella controllers that miss purge cassettes HighLife raises 80 million euros for a mitral valve CE marked in January Xenix Medical clears the Riva Anchor for sacroiliac fusion at the base of a lumbar construct Dialybrid raises 15 million euros as its silk polyurethane dialysis graft reaches a first patient CMS posts preliminary 2027 lab rates and cuts more than 1,100 test codes FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel backs GRAIL's Galleri on a 6 to 4 effectiveness vote TriSalus clears TriNav Advance, its fourth pressure-enabled infusion device Anaconda Biomed raises $56M to finish a 327-patient stroke trial FDA issues an early alert on Impella controllers that miss purge cassettes HighLife raises 80 million euros for a mitral valve CE marked in January Xenix Medical clears the Riva Anchor for sacroiliac fusion at the base of a lumbar construct Dialybrid raises 15 million euros as its silk polyurethane dialysis graft reaches a first patient CMS posts preliminary 2027 lab rates and cuts more than 1,100 test codes FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US

The Directory / GI & Urology

GI & Urology Diabetes & Metabolic

Aqua Medical

Pleasanton, CA · Series B · 510(k) cleared

Radiofrequency vapor ablation delivered through an endoscope working channel. The system is cleared for GI tract ablation, and the company is testing a duodenal mucosal ablation procedure for type 2 diabetes under an FDA IDE.

← More GI & Urology startups