Patient
Nuubo patient monitoring is a simple and convenient experience, guaranteeing a high level of compliance more information
Health Professionals
Nuubo provides a new perspective on remote and wireless cardiological monitoring. It is indicated for the medium and long-term monitoring. Offering high predictability and flexibility. more information
Company
Nuubo is a non-invasive, disruptive ambulatory electrocardiogram (aECG) with wireless, textile-based wearable technology that enables mid and long-term monitoring more information

Nuubo Technology Overview

The Nuubo textile electrode has been designed to obtain the best ECG signal quality while achieving best-in-class patient comfort

Silver textile-electrode composite + ECG cream
  • Avoid skin allergies
  • Optimal electrode performance quality
Flexible and stretchable conductive tracks
  • Patient comfort during daily activities
  • Electrode location flexibility
Seamless fabrics with two elastic axes
  • High-quality and comfortable fabric without adhesives
more information
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Nuubo Receives U.S. FDA 510(k) Clearance for the Nuubo System

Spanish medical device innovator Nuubo (https://www.nuubo.com) today announced it has received United States Food and Drug Administration (FDA) 510(k) clearance to market its Nuubo System, a disruptive wireless, textile-based ambulatory electrocardiogram (aECG) technology that enables mid and long-term monitoring for cardiac arrhythmia diagnosis.

Spanish medical device innovator Nuubo (https://www.nuubo.com) today announced it has received United States Food and Drug Administration (FDA) 510(k) clearance to market 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.

“This is just the beginning of an exciting journey to provide cardiologists and patients with a better aECG monitoring experience,” said Daniel Llorca, Nuubo Product Development Director. “Nuubo is committed to better patient outcomes and innovation in digital remote aECG technologies. We are excited about the US launch of the Nuubo System and look forward to the future of Nuubo and its near-term product pipeline.”

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