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Terumo Neuro receives FDA approval for carotid stent system
Terumo Neuro has announced that its carotid stent system has received premarket approval (PMA) from the Food and Drug Administration (FDA). This milestone marks the first dual-layer micromesh carotid stent approved in the U.S., offering physicians a clinically proven option…
Sonovein FDA pivotal study treatments completed: Theraclion reaches key milestone on schedule
Theraclion, a French MedTech company developing a robotic platform for non-invasive high-intensity focused ultrasound (HIFU) therapy, announces today that treatments in the Food and Drug Administration (FDA) pivotal study for Sonovein, an extracorporeal medical device made to treat varicose veins using…
First post-FDA approval implant of Duo venous stent system announced
Royal Philips today announced the first implant of the Duo venous stent system, indicated to treat symptomatic venous outflow obstruction in patients with chronic venous insufficiency (CVI), following premarket approval (PMA) from the Food and Drug Association (FDA). On June…
Swiss parliament votes to accept FDA-approved medical devices
The Swiss Federal Assembly has voted in favor of accepting medical devices with the Food and Drug Administration (FDA) marketing authorization in Switzerland. A motion for ‘more freedom of action in the procurement of medical products for supply of the…
Newly FDA-approved device for central venous occlusions hailed as exciting advance
HOUSTON—These are exciting times in the theater of dialysis access, expert in the field Eric Peden, MD, mused in the latter part of last year—“and that’s not always been easy to say because dialysis has had not too much change…
Alucent Biomedical announces FDA approval to proceed with natural vascular scaffolding clinical trial
Alucent Biomedical has received US Food and Drug Administration (FDA) approval to proceed with a phase 1 clinical trial to evaluate the safety and efficacy of its Natural Vascular Scaffolding (NVS) technology. The therapy is designed to treat peripheral arterial…