Amplifi Vascular wins FDA breakthrough nod for vein dilation system
January 18, 2026
Amplifi Vascular announced that it received breakthrough device designation for its Amplifi Vein Dilation System.
Amplifi Vascular announced that it received breakthrough device designation for its Amplifi Vein Dilation System.
Elekta announced today that its Evo CT linear accelerator (linac) received FDA 510(k) clearance, making it available to U.S. radiation oncology professionals.
SEATTLE, Jan. 15, 2026 /PRNewswire/ — Proprio, the surgical technology company pioneering real-time, AI-powered intraoperative guidance and data-driven surgical workflows, today announced the U.S. Food and Drug Administration (FDA) has granted clearance for the “Picasso” feature. This marks the company’s fourth FDA-cleared capability within its Paradigm platform.
BD (NYSE: BDX)+
announced today that the FDA granted 510(k) clearance for its EnCore EnCompass breast biopsy and tissue removal system.
EndoQuest Robotics announced today that the FDA approved the initiation of the next and final stage of its PARADIGM trial.
IotaMotion announced today that it received FDA 510(k) clearance for expanded pediatric use of its iotaSoft insertion system.
Boston Scientific (NYSE: BSX)+
announced that it received CE mark approval for its Embold detachable coil system.
A Boston Scientific (NYSE: BSX)+
executive said on social media that the company received FDA approval for its Farapoint pulsed field ablation (PFA) catheter.
AliveCor announced today that it received FDA clearance for the next generation of its AI technology for the Kardia 12L ECG system.
Minneapolis-based Imricor Medical Systems (ASX:IMR) said it won 510(k) clearance from the FDA for its Vision-MR Diagnostic Catheter.