Balt announced that it received CE Mark approval for its Silk Vista flow diverting stent for treating patients with unruptured intracranial aneurysms. Montmorency, France.-based Balt designed its Silk Vista device for predictable and accurate deployment and high visibility under angiography, adding to its already-CE-Marked Silk Vista baby flow diverter, which has been approved in Europe […]
Kardium lands CE Mark for mapping and ablation device
Kardium announced that it received CE Mark approval in Europe for its Globe mapping and ablation system for treating atrial fibrillation (AF). Vancouver, B.C.-based Kardium’s spherical Globe catheter is comprised of 122 electrodes to provide electrophysiologists with single-shot pulmonary vein isolation, high-definition mapping and atrial ablation, according to a news release. Approval in Europe came […]
Ancora Heart wins IDE for ventricular restoration system
Ancora Heart announced today that it received FDA investigational device exemption (IDE) for its AccuCinch ventricular restoration system. AccuCinch is designed to treat patients with heart failure and reduced ejection fraction (HFrEF) by directly reshaping the left ventricle of the heart to address the fundamental issue in the progression of systolic heart failure, according to […]
Protaryx Medical raises $8.3m
Protaryx Medical announced today that it raised $8.3 million for the development of its first-in-class device for transseptal access to the left atrium. The Baltimore-based company’s funding includes non-dilutive grants and a seed round totaling $3.2 million, along with a recently closed $5.1 million Series A round led by Ajax Health, with participation from returning […]
20 medical device startups you need to know
The medtech industry isn’t immune from COVID-19 troubles, but exciting innovation continues. These 20 medical device startups have grabbed our attention. Tom Salemi, DeviceTalks Editorial Director and Sean Whooley, Assistant Editor A number of medical device startups continue to make waves across the space, with new technologies and eye-watering fundraising rounds highlighting some exciting prospects. […]
Medtronic lands CE Mark for Micra AV transcatheter pacing system
Medtronic (NYSE:MDT) announced today that it received CE Mark approval in Europe for its Micra AV transcatheter pacing system (TPS). The Fridley, Minn.-based medtech giant touts its Micra AV as the world’s smallest pacemaker with atrioventricular (AV) synchrony. The system is indicated for treating patients with AV block, adding to its CE Mark-approved leadless pacemaker portfolio. […]
Okami Medical raises $7.2m to support vascular occlusion system
Months after the first use of its LOBO vascular occlusion system on patients, Okami Medical has raised more than $7.2 million. The Aliso Viejo, Calif.–based company raised the money from 18 investors, according to an SEC Form D filed June 10. After securing FDA clearance in late 2019, Okami Medical announced the first use of […]
Edwards Lifesciences wins approval in China for Sapien 3
Edwards Lifesciences (NYSE:EW) announced today that it received regulatory approval in China for its Sapien 3 transcatheter heart valve. Sapien 3 TAVR (transcatheter aortic valve replacement) is used in the treatment of patients suffering from severe, symptomatic aortic stenosis (AS) who are at high risk for or unable to undergo open-heart surgery. According to a news […]
Abbott issues urgent field safety notice over ablation catheter
Abbott (NYSE:ABT) has issued an urgent field safety notice to notify users of complaints about the TactiCath quartz contact force ablation catheter. The notice out of Germany, dated May 28, warns on complaints regarding a loss of contact force information while using the TactiCath product. This issue could cause ineffective ablation that could lead to atrial […]
Boston Scientific launches DirectSense technology
Boston Scientific (NYSE:BSX) announced today that it launched its DirectSense for monitoring the effect of radiofrequency (RF) energy during cardiac ablation procedures. Marlborough, Mass.-based Boston Scientific’s DirectSense is available on the Rhythmia HDx mapping system that won FDA approval in April. Rhythmia HDx monitors changes in local impedance — electrical resistance — around the tip of […]
Acutus Medical, Biotronik ink deal
Acutus Medical and Biotronik have announced that they will collaborate on electrophysiology, mapping, ablation and accessory products across certain markets. The products involved in the collaboration center around the treatment of cardiac arrhythmias in markets that include Europe and Asia, according to a news release. The partnership centers on Acutus’ AcQMap system, which Acutus touts […]
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