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New iteration of electrophysiology mapping system receives FDA clearance
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Acutus Medical announced that a second generation of its mapping system for electrophysiology procedures received clearance from the FDA.
The system (AcQMap, Acutus Medical) can create ultra-high-resolution 3D images with ultrasound and map electrical patterns, which uses non-contact, charge density technology, according to a press release from the company. This real-time visualization can be used during a variety of electrophysiology procedures.
The company also announced that contact mapping software for use on the AcQMap received a CE mark for commercial use in Europe. The contact mapping software is not yet cleared for commercial use in the United States.
The development of this system involved discussions with physicians to learn more about their needs, according to the release.
“We worked alongside physician partners to understand complex challenges and simple needs to improve the efficiency and safety of electrophysiology procedures,” Vince Burgess, CEO of Acutus Medical, said in the release. “This next-gen AcQMap system has the capability to exponentially improve the day-to-day clinical utility of cardiac mapping and deliver long-term value by offering health systems a comprehensive solution for electrophysiologists and their patients.”
The second-generation non-contact mapping platform will be available in the U.S. in the third quarter of this year, according to the release.
Disclosure: Burgess is an employee of Acutus Medical.
Editor’s Note: This article was revised on April 26, 2019 to clarify that the non-contact mapping system, not the contact mapping software, received FDA clearance. The Editors regret the error.