Sam Brusco, Associate Editor12.06.22
Arrhythmia management firm Acutus Medical has received a CE mark for its AcQMap 3D imaging and mapping catheter. According to the company, it’s the world’s only integrated high-resolution ultrasound imaging and non-contact mapping catheter.
“Obtaining our MDR CE Mark for AcQMap well before the transition date ensures that European patients and physicians will have continued access to our unique mapping technology offering individualized diagnosis and a personalized treatment plan for even the most complex arrhythmias,” Shibaji Shome, Acutus’ VP of marketing told the press. “The MDR, with a significant focus on quality and safety, is well aligned with our commitment to improve patient care through innovative and high-quality medical devices. Importantly, this approval positions us well for further expansion and growth within the European markets.”
The company also gained EU MDR certification of its quality management system. Acutus aims to file for EU MDR approval for the remaining products in its portfolio to ensure compliance by the May of 2024 deadline.
“Obtaining our MDR CE Mark for AcQMap well before the transition date ensures that European patients and physicians will have continued access to our unique mapping technology offering individualized diagnosis and a personalized treatment plan for even the most complex arrhythmias,” Shibaji Shome, Acutus’ VP of marketing told the press. “The MDR, with a significant focus on quality and safety, is well aligned with our commitment to improve patient care through innovative and high-quality medical devices. Importantly, this approval positions us well for further expansion and growth within the European markets.”
The company also gained EU MDR certification of its quality management system. Acutus aims to file for EU MDR approval for the remaining products in its portfolio to ensure compliance by the May of 2024 deadline.