Spanish medical device innovator Nuubo has received United States Food and Drug Administration (FDA) 510(k) clearance to market in the US its Nuubo System, a disruptive wireless, textile-based ambulatory electrocardiogram (aECG) technology that enables mid and long-term monitoring for cardiac arrhythmia diagnosis.
The Nuubo System is designed to obtain the highest ECG signal quality while achieving best-in class patient comfort for monitoring up to 30 days. The non-invasive device consists of a seamless wearable fabric with multi-lead sensor technology that is flexible and stretchable. The Nuubo System is simple to use and has no adhesives or wires, improving patient comfort while increasing patient compliance and arrhythmia diagnostic yield.
The FDA clearance allows Nuubo to market and sell the Nuubo System to US hospitals and clinics for use in detecting and monitoring cardiac arrhythmias for ambulatory patients. The Nuubo System will be prescribed by a qualified healthcare professional when diagnostic and post-procedure monitoring is needed. The company anticipates US commercial availability of the Nuubo System later this year. “We are pleased to have received FDA 510(k) clearance to bring the Nuubo System to US healthcare providers and patients,” said Juan Alcántara, Nuubo CEO. “With more than 25,000 patients monitored by Nuubo in Europe, we are ready to launch in the US, the largest aECG market.”
Alcántara also noted that Nuubo system is the fifth Spanish FDA cleared product in the past five years. “This great accomplishment is the result of hard work from Nuubo’s talented team and their commitment to patient-centric ECG technology innovation. In addition to recognizing the Nuubo
team for this achievement, I also want to thank the Nuubo board members and investors for their continued support,” said Alcántara.