InspireMD (Nasdaq:NSPR) announced today that it submitted a premarket approval (PMA) application to the FDA for its CGuard system. The company designed the CGuard Prime carotid stent system, made from nitinol, for the treatment of carotid artery stenosis. It based its PMA application on positive one-year data from the company's C-GUARDIANS … [Read more...] about InspireMD submits carotid stent for FDA premarket approval
Pre-Market Approval (PMA)
Philips launches Duo venous stent system with FDA approval
Philips today announced the first implant of its Duo venous stent system following FDA premarket approval. Duo, an implantable medical device, treats symptomatic venous outflow obstruction in patients with chronic venous insufficiency (CVI). Amsterdam-based Philips added Duo to its portfolio when it acquired Vesper Medical in 2021. On June … [Read more...] about Philips launches Duo venous stent system with FDA approval
