European regulators approved Acutus Medical’s flagship ‘Katheter’ device, a diagnostic catheter for real-time 3D imaging and mapping of the heart.
The Katheter is just a part of Acutus Medical’s larger stand-alone system, the company said. The device contains 48 ultrasound crystals and electrodes that capture both the geometry of the heart and its electrical activity.
"This is the 1st step toward commercializing the entire system designed to map the true electrical source of the heart wall’s electrical activation," president & CEO Randy Werneth said in prepared remarks. "This 1st-generation product will be used to collect clinical evidence in support of the anticipated benefits of this novel stand-alone system."
This is the 1st regulatory nod for the company, which has in recent years collected millions from the likes of GE Ventures, Orbimed and other investors.
Acutus has been lucky on the fundraising trail, Werneth told MassDevice.com last year, noting that the company is aiming at a growth market – cardiac arrhythmias – and has a proven technology, given the completion of a clinical trial.
"I don’t want to sound arrogant, but you put those 2 things together and I had a pretty easy time," he said.