Acutus Medical today announced it submitted pivotal clinical data of its AcQBlate force-sensing ablation catheter to the FDA for premarket approval. The Carlsbad, California-based company submitted data from the AcQForce Flutter trial, a prospective, multicenter, non-randomized study approved under an FDA investigational device exemption … [Read more...] about Acutus Medical submits AcQBlate force-sensing ablation catheter for FDA premarket approval
Acutus Medical
Acutus Medical wins regulatory approval in Japan for non-contact cardiac mapping catheter
Acutus Medical this week announced it received regulatory approval in Japan for its AcQMap high resolution imaging and mapping system and the AcQMap 3D imaging and mapping catheter. The approval represents a new era of non-contact arrhythmia management in Japan. Acutus Medical and its international alliance partner Biotronik have commenced … [Read more...] about Acutus Medical wins regulatory approval in Japan for non-contact cardiac mapping catheter
Design challenges to overcome when developing cardiac ablation devices
It’s about figuring out how and where to go with the cardiac ablation and then engineering the best catheter-based delivery device, according to a top Acutus Medical scientist. Cardiac ablation is when a physician intentionally destroys a small amount of tissue in the heart to treat and prevent heart rhythm problems. The procedure creates … [Read more...] about Design challenges to overcome when developing cardiac ablation devices
What is pulsed-field ablation? Here’s what you need to know
Top experts at Boston Scientific, Medtronic and Acutus Medical shared insights about pulsed-field ablation’s potential at DeviceTalks Boston. Pulsed-field ablation is a non-thermal method for cardiac ablation that has the potential to positively disrupt the way atrial fibrillation is treated. PFA’s roots go back to the dc ablation tech of the … [Read more...] about What is pulsed-field ablation? Here’s what you need to know
Acutus Medical sells left-heart access portfolio to Medtronic in $50M deal
Acutus Medical (NSDQ:AFIB) today announced that it has entered a definitive agreement to sell its left-heart access portfolio to Medtronic (NYSE:MDT) for $50 million. Medtronic will make an upfront cash payment to Princeton, N.J.–based Acutus Medical of $50 million upon the initial closing of the transaction, which is subject to the satisfaction … [Read more...] about Acutus Medical sells left-heart access portfolio to Medtronic in $50M deal
FDA clears Acutus Medical suite of universal transseptal crossing devices
Acutus Medical announced that it received FDA clearance for its AcQCross family of universal transseptal crossing devices. Carlsbad, Calif.-based Acutus touts the AcQCross system as the first and only transseptal puncture system specifically engineered to pair and mate seamlessly with Acutus' suite of sheaths, as well as with sheaths sold by … [Read more...] about FDA clears Acutus Medical suite of universal transseptal crossing devices
Acutus Medical names new chief financial officer
Acutus Medical (Nasdaq: AFIB) today announced that it appointed David Roman as its CFO, effective March 1. Founded in 2011, Carlsbad, Calif.–based Acutus Medical boasts a portfolio of electrophysiology products that includes catheter-based treatments for cardiac arrhythmias. Roman has more than 15 years of experience in the medical technology … [Read more...] about Acutus Medical names new chief financial officer
Acutus Medical transseptal crossing wins CE mark
Acutus Medical today said it received CE mark approval for its transseptal crossing products. The device is designed to deliver safe and efficient access to the left atrium of the heart. It includes the company's AcQCross Qx with either the AcQGuide Mini or steerable AcQGuide Flex introducer sheath. AcQCross Qx features an integrated needle … [Read more...] about Acutus Medical transseptal crossing wins CE mark
Acutus Medical launches cardiac ablation system in Europe
Acutus Medical yesterday launched its AcQBlate Force Sensing Ablation System following the CE mark approval of its Force ablation catheter. When used with the company's AcQMap, the ablation system is designed for the electrophysiologic mapping and RF ablation of cardiac arrhythmias. It shows physicians in real-time how much contact is being … [Read more...] about Acutus Medical launches cardiac ablation system in Europe
Acutus Medical 3D imaging and mapping catheter wins FDA clearance
Acutus medical recently won FDA 510(k) clearance of its AcQMap 3D imaging and mapping catheter. The mapping catheter builds on its predecessor and improves handling and deliverability. It combines 48 ultrasound transducers responsible for creating anatomical geometry and 48 engineered electrodes that enable electrical activation patterns to … [Read more...] about Acutus Medical 3D imaging and mapping catheter wins FDA clearance
