Fitbit Receives FDA Approval For Wearable Device App That Detects Atrial Fibrillation


Many companies want to adapt consumer wearable devices to monitor health conditions, including biomarkers tested by medical laboratories

Managers of clinical laboratories know that portable devices for monitoring biophysical functions or measuring biomarkers are becoming increasingly complex and capable thanks to advances in miniaturization, computing, software and machine learning. artificial intelligence that allow new functions to be developed and their accuracy to be proven.

In September, Fitbit (NYSE: FIT) took it one step further. The San Francisco-based personal fitness technology maker “has received 510 (k) clearance from the United States Food and Drug Administration (FDA), as well as European Conformity (CE Mark) in the European Union,” for its application of electrocardiogram (ECG) to assess heart rate for atrial fibrillation (AFib), ”according to a press release.

The fact that Google is currently in the process of acquiring Fitbit for $ 2.1 billion may indicate that wearable devices to help doctors and patients diagnose and monitor health conditions will be big business in the future.

New ECG app is available on Fitbit Sense
The new ECG application is available on Fitbit sense (above), an “advanced health smartwatch”. To use the app, users place their finger and thumb on the stainless steel corners of the watch and stand still for 30 seconds. The app analyzes the heart rate for signs of AFib. Individuals can take heart rate readings at any time, monitor irregularities, and save and share data. (Photo Copyright: Fitbit.)

Help physicians “stay better connected” to their patients

“Helping people understand and manage their heart health has always been a priority for Fitbit, and our new ECG app is designed for users who want to check themselves in the moment and review the reading later with their doctor,” said said Eric Friedman, Fitbit co-founder and Chief Technology Officer, in the press release.

Before submitting the device for approval to regulatory agencies, Fitbit conducted the clinical trial in areas of the United States to assess the device’s ability to accurately detect AFib from a normal sinus rhythm. and generating ECG traces. The researchers proved that their algorithm was able to detect 98.7% of AFib cases (sensitivity) and was able to accurately identify normal sinus rhythms (specificity) in 100% of cases.

Venkatesh Raman, MD, an interventional cardiologist and medical director of the Cardiac Catheterization Lab at the 609-bed MedStar Georgetown University Hospital, was the principal investigator of the Fitbit ECG application clinical study. “Doctors often fly blindly about the daily lives of our patients between office visits. I have long believed in the potential of wearable devices to help us stay better connected and use individual real-world data to provide more informed and personalized care, ”he said in the press release.

“Considering the toll AFib continues to take on individuals and families around the world,” Raman continued, “I am very excited about the potential of this tool to help people detect possible AFib – a clinically important rhythm abnormality – even after their departure. the doctor’s office.

Fitbit ECG app receives European CE mark

In addition to receiving approval for the Fitbit ECG app in the United States, the device has also received CE (Conformité Européenne) mark for use in certain European countries.

In October 2020, the app was made available to Fitbit Sense users in the United States, Austria, Belgium, Czech Republic, France, Germany, Ireland, Italy, Luxembourg, Countries -Bas, Poland, Portugal, Romania, Spain, Sweden, Switzerland and UK. The device has also received approval for use in Hong Kong and India.

It is estimated that more than 33.5 million people worldwide suffer from AFib, an irregular heartbeat (arrhythmia) that can lead to stroke, blood clots or heart failure. The American Heart Association estimates that at least 2.7 million Americans are currently living with the disease. The most common symptoms experienced by people with the disease are:

  • Irregular heartbeat,
  • Heart palpitations (rapid, throbbing, shaking or throbbing),
  • dizziness
  • Extreme fatigue,
  • Shortness of breath, and
  • Chest pain.

Risk factors for AFib include advanced age, high blood pressure, obesity, diabetes, European ancestry, hyperthyroidism, chronic kidney disease, alcohol use, smoking, and known heart problems such as heart failure, ischemic heart disease, and enlarged chambers on the left side of the heart.

According to the Centers for Disease Control and Prevention (CDC), there are more than 454,000 hospitalizations each year in the United States that list AFib as the primary diagnosis. In 2018, AFib was mentioned on 175,326 death certificates, with disease being the underlying cause of death in 25,845 of these cases.

The CDC reports that cases are on the increase and predicts that by 2030, 12.1 million people in the United States will have AFib. Many people have the disease asymptomatic and are unaware they have it, which can make diagnosing AFib more difficult.

“Early detection of AFib is essential, and I am extremely happy that we are making these innovations available to people around the world to help them improve their heart health, prevent more serious disease and potentially save lives,” Friedman said, in a statement.

Those in charge of clinical laboratories must follow these developments closely. Fitbit’s FDA clearance and CE mark for its ECG app suggest this trend is accelerating.

—JP Schlingman

Related information:

Fitbit’s ECG App Gets FDA Green Light to Track Heart Rhythm Irregularities

Fitbit Obtains Regulatory Clearance in US and Europe for ECG App to Identify Atrial Fibrillation (AFib)

Fitbit’s Sense Smartwatch Gets FDA Clearance for EKG App

What the FDA clearance of the Apple Watch actually means

FDA confirms Samsung’s Galaxy Watch 3 cleared for ECG, just like Apple Watch

Fitbit to be acquired by Google

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