US-based consumer electronics and fitness company Fitbit has secured the US Food and Drug Administration’s (FDA) 510(k) clearance and CE marking in the EU for its electrocardiogram (ECG) app.
Fitbit’s device-compatible ECG app is designed to evaluate heart rhythm for signs of atrial fibrillation (AFib) by measuring the electrical activity of the heart.
People can use the app to take an on-the-spot reading of their heart rhythm at any time, including whenever they notice any unusual cardiac symptoms, the company said.
The regulatory clearance for the Fitbit ECG App follows a multi-site clinical trial conducted by the company across the US.
The study assessed the ability of Fitbit’s algorithm to precisely detect AFib from normal sinus rhythm and to generate an ECG trace. It demonstrated the ability to detect 98.7% of AFib cases and was 100% accurate in identifying study participants with normal sinus rhythm.
Fitbit co-founder and CTO Eric Friedman said: “Helping people understand and manage their heart health has always been a priority for Fitbit, and our new ECG app is designed for those users who want to assess themselves in the moment and review the reading later with their doctor.
“Early detection of AFib is critical, and I am incredibly excited that we are making these innovations accessible to people around the world to help them improve their heart health, prevent more serious conditions and potentially save lives.”
AFib, which is said to affect over 33.5 million people worldwide, increases the risk of serious complications such as stroke. The condition is considered difficult to diagnose as episodes often show no symptoms.
The Fitbit ECG App will be available next month to users on Fitbit Sense in countries, including the US, UK, Germany, Austria, Luxembourg, the Netherlands, Sweden, Switzerland, Czech Republic, Poland, Belgium, Portugal, Romania, Ireland, Italy, Spain, France, Hong Kong and India.
In a separate development, Fibralign, a maker of therapeutic biomedical devices, has received CE mark for its BioBridge Collagen Matrix.
The company’s first product, BioBridge, is a Class III device for lymphatic tissue repair. It can be used after or in conjunction with surgical procedures, addressing lymphedema.