Regulatory Approvals

Fasikl has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Felix NeuroAI Wristband, designed to address tremor-related functional limitations...

Methinks AI announced its non-contrast computed tomography (NCCT) Stroke software has received 510(k) clearance from the US Food and Drug Administration (FDA). A press...

Intuitive Surgical received CE mark for its da Vinci 5 surgical robotic system. The surgical robotics leader earned approval for adult and pediatric use in Europe....

Neurent Medical announced Cigna Healthcare intends to provide coverage for its Neuromark system for chronic rhinitis. Cigna will provide coverage for Neuromark for treating the...

Glaukos announced it received EU MDR certification for its iStent Infinite, along with several other technologies. Aliso Viejo, California-based Glaukos can now bring iStent Infinite...

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...