Regulatory Approvals

Vivasure Medical announced today that it submitted its PerQSeal Elite vascular closure system to the FDA for premarket approval (PMA). Galway, Ireland-based Vivasure designed the...

Amid reports that Exo could pull in $100m from investors, the imaging startup has obtained 510(k) clearance from the US Food and Drug Administration...

Neuspera Medical has obtained U.S. Food and Drug Administration (FDA) approval for its integrated sacral neuromodulation (iSNM) system to treat urinary urge incontinence (UUI). The...

Levita Magnetics announced that it received expanded FDA 510(k) clearance for its MARS (magnetic-assisted robotic surgery) system. The FDA granted 510(k) clearance for its Magnetic...

ANACONDA Biomed, a medical technology company developing next-generation thrombectomy systems for the treatment of ischemic stroke, has announced that it has received CE Mark...

Brain Navi Biotechnology announced today that it received FDA 510(k) clearance for its NaoTrac stereotaxic guiding surgical robotic device. Zhubei City, Taiwan–based Brain Navi —...

Italy-based Bracco Imaging and Subtle Medical have obtained an EU CE mark for AiMIFY, a jointly developed software designed to enhance the imaging of...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Viz.ai for its Viz Subdural Plus module, designed for enhancing clinical decision-making. It...

GI Windows Surgical received FDA 510(k) clearance for its Flexagon self-forming magnet technology. The FDA granted clearance for the Flexagon laparoscopic and endoscopic delivery system....