Fitbit Cleared by FDA For Algorithm to Identify Atrial Fibrillation

<p class&equals;"drop-cap">Fitbit says it has received clearance from the U&period;S&period; Food and Drug Administration for a new PPG &lpar;photoplethysmography&rpar; algorithm to identify atrial fibrillation &lpar;AFib&rpar;&period; The algorithm will power new Irregular Heart Rhythm Notifications feature on Fitbit&period;<&sol;p>&NewLine;<p>Fitbit is a subsidiary of Google&period;<&sol;p>&NewLine;<p>AFib is a form of irregular heart rhythm that <a href&equals;"https&colon;&sol;&sol;pubmed&period;ncbi&period;nlm&period;nih&period;gov&sol;24345399&sol;" target&equals;"&lowbar;blank" rel&equals;"noopener" data-analytics-onclick&equals;"&lbrace;&quot&semi;event&quot&semi;&colon;&quot&semi;page interaction&quot&semi;&comma;&quot&semi;category&quot&semi;&colon;&quot&semi;in-article links&quot&semi;&comma;&quot&semi;action&quot&semi;&colon;&quot&semi;link click&quot&semi;&comma;&quot&semi;label&quot&semi;&colon;&quot&semi;https&colon;&sol;&sol;pubmed&period;ncbi&period;nlm&period;nih&period;gov&sol;24345399&sol;&quot&semi;&rcub;">affects nearly 33&period;5 million people globally<&sol;a>&comma; and <a href&equals;"https&colon;&sol;&sol;pubmed&period;ncbi&period;nlm&period;nih&period;gov&sol;1866765&sol;" target&equals;"&lowbar;blank" rel&equals;"noopener" data-analytics-onclick&equals;"&lbrace;&quot&semi;event&quot&semi;&colon;&quot&semi;page interaction&quot&semi;&comma;&quot&semi;category&quot&semi;&colon;&quot&semi;in-article links&quot&semi;&comma;&quot&semi;action&quot&semi;&colon;&quot&semi;link click&quot&semi;&comma;&quot&semi;label&quot&semi;&colon;&quot&semi;https&colon;&sol;&sol;pubmed&period;ncbi&period;nlm&period;nih&period;gov&sol;1866765&sol;&quot&semi;&rcub;">individuals with AFib have five times higher risk of stroke<&sol;a>&period; Unfortunately&comma; <a href&equals;"https&colon;&sol;&sol;www&period;nejm&period;org&sol;doi&sol;full&sol;10&period;1056&sol;nejmoa1105575" target&equals;"&lowbar;blank" rel&equals;"noopener" data-analytics-onclick&equals;"&lbrace;&quot&semi;event&quot&semi;&colon;&quot&semi;page interaction&quot&semi;&comma;&quot&semi;category&quot&semi;&colon;&quot&semi;in-article links&quot&semi;&comma;&quot&semi;action&quot&semi;&colon;&quot&semi;link click&quot&semi;&comma;&quot&semi;label&quot&semi;&colon;&quot&semi;https&colon;&sol;&sol;www&period;nejm&period;org&sol;doi&sol;full&sol;10&period;1056&sol;nejmoa1105575&quot&semi;&rcub;">AFib can be difficult to detect<&sol;a> as there are often no symptoms and episodes can come and go&period;<&sol;p>&NewLine;<p>Fitbit&&num;8217&semi;s new PPG AFib algorithm can passively assess your heart rhythm in the background while you’re still or asleep&period; If there’s anything that might be suggestive of AFib&comma; you’ll be notified through our Irregular Heart Rhythm Notifications feature — allowing you to talk with your healthcare provider or seek further assessment to help prevent a significant medical event&comma; such as stroke&period;<&sol;p>&NewLine;<p>When your heart beats&comma; tiny blood vessels throughout your body expand and contract based on changes in blood volume&period; Fitbit’s PPG optical heart-rate sensor can detect these volume changes right from your wrist&period; These measurements determine your heart rhythm&comma; which the detection algorithm then analyzes for irregularities and potential signs of atrial fibrillation&period;<&sol;p>&NewLine;<p>The clinical validation for Fitbit’s PPG algorithm is supported by data from the landmark Fitbit Heart Study&comma; which <a href&equals;"https&colon;&sol;&sol;press&period;fitbit&period;com&sol;press-releases&sol;press-release-details&sol;2020&sol;Fitbit-Announces-Large-Scale-Study-to-Identify-Atrial-Fibrillation&sol;default&period;aspx" target&equals;"&lowbar;blank" rel&equals;"noopener" data-analytics-onclick&equals;"&lbrace;&quot&semi;event&quot&semi;&colon;&quot&semi;page interaction&quot&semi;&comma;&quot&semi;category&quot&semi;&colon;&quot&semi;in-article links&quot&semi;&comma;&quot&semi;action&quot&semi;&colon;&quot&semi;link click&quot&semi;&comma;&quot&semi;label&quot&semi;&colon;&quot&semi;https&colon;&sol;&sol;press&period;fitbit&period;com&sol;press-releases&sol;press-release-details&sol;2020&sol;Fitbit-Announces-Large-Scale-Study-to-Identify-Atrial-Fibrillation&sol;default&period;aspx&quot&semi;&rcub;">launched<&sol;a> in 2020 and enrolled 455&comma;699 participants over five months&period; The study was conducted entirely virtually during the pandemic&comma; making it <a href&equals;"https&colon;&sol;&sol;pubmed&period;ncbi&period;nlm&period;nih&period;gov&sol;33865810&sol;" target&equals;"&lowbar;blank" rel&equals;"noopener" data-analytics-onclick&equals;"&lbrace;&quot&semi;event&quot&semi;&colon;&quot&semi;page interaction&quot&semi;&comma;&quot&semi;category&quot&semi;&colon;&quot&semi;in-article links&quot&semi;&comma;&quot&semi;action&quot&semi;&colon;&quot&semi;link click&quot&semi;&comma;&quot&semi;label&quot&semi;&colon;&quot&semi;https&colon;&sol;&sol;pubmed&period;ncbi&period;nlm&period;nih&period;gov&sol;33865810&sol;&quot&semi;&rcub;">one of the largest remote studies of PPG-based software<&sol;a> to date&period; Data presented at the 2021 <a href&equals;"https&colon;&sol;&sol;newsroom&period;heart&period;org&sol;news&sol;novel-algorithm-on-wearable-devices-can-detect-irregular-heartbeat-may-prompt-early-care" target&equals;"&lowbar;blank" rel&equals;"noopener" data-analytics-onclick&equals;"&lbrace;&quot&semi;event&quot&semi;&colon;&quot&semi;page interaction&quot&semi;&comma;&quot&semi;category&quot&semi;&colon;&quot&semi;in-article links&quot&semi;&comma;&quot&semi;action&quot&semi;&colon;&quot&semi;link click&quot&semi;&comma;&quot&semi;label&quot&semi;&colon;&quot&semi;https&colon;&sol;&sol;newsroom&period;heart&period;org&sol;news&sol;novel-algorithm-on-wearable-devices-can-detect-irregular-heartbeat-may-prompt-early-care&quot&semi;&rcub;">American Heart Association Scientific Sessions<&sol;a> found that the Fitbit PPG detections correctly identified AFib episodes 98&percnt; of the time&comma; as confirmed by ECG patch monitors&period;<&sol;p>&NewLine;<p>Because AFib can be so sporadic&comma; the optimal way to screen for it is through <a href&equals;"https&colon;&sol;&sol;pubmed&period;ncbi&period;nlm&period;nih&period;gov&sol;17322588&sol;" target&equals;"&lowbar;blank" rel&equals;"noopener" data-analytics-onclick&equals;"&lbrace;&quot&semi;event&quot&semi;&colon;&quot&semi;page interaction&quot&semi;&comma;&quot&semi;category&quot&semi;&colon;&quot&semi;in-article links&quot&semi;&comma;&quot&semi;action&quot&semi;&colon;&quot&semi;link click&quot&semi;&comma;&quot&semi;label&quot&semi;&colon;&quot&semi;https&colon;&sol;&sol;pubmed&period;ncbi&period;nlm&period;nih&period;gov&sol;17322588&sol;&quot&semi;&rcub;">heart rate tracking technology when the body is still or at rest<&sol;a> — making overnight detection when people are asleep especially important&period; The unique capabilities of Fitbit devices — especially its 24&sol;7 heart rate tracking and long battery life — give it the potential to accelerate identification through long-term heart rhythm assessment&period;<&sol;p>&NewLine;<p>With FDA clearance of the PPG-based algorithm&comma; Fitbit now provides two ways to detect AFib&period; Fitbit’s ECG app&comma; which takes a spot-check approach&comma; allows you to proactively screen yourself for possible AFib and record an ECG trace that you can then review with a healthcare provider&period; Additionally&comma; the new PPG-based algorithm allows for long-term heart rhythm assessment that helps identify asymptomatic AFib that could otherwise go undetected&period;<&sol;p>&NewLine;<p>The Fitbit PPG-based algorithm and Irregular Heart Rhythm Notifications feature will soon be available to consumers in the U&period;S&period; across a range of heart-rate enabled devices&period; We want to make AFib detection as accessible as possible to help reduce the risk of potentially life-threatening events — like stroke — and ultimately improve overall heart health for everyone&period; We’ll continue to work with the <a href&equals;"https&colon;&sol;&sol;press&period;fitbit&period;com&sol;press-releases&sol;press-release-details&sol;2019&sol;The-Bristol-Myers-Squibb-Pfizer-Alliance-and-Fitbit-Collaborate-to-Address-Gaps-in-Atrial-Fibrillation-Detection-with-the-Aim-of-Accelerating-Diagnosis&sol;default&period;aspx" target&equals;"&lowbar;blank" rel&equals;"noopener" data-analytics-onclick&equals;"&lbrace;&quot&semi;event&quot&semi;&colon;&quot&semi;page interaction&quot&semi;&comma;&quot&semi;category&quot&semi;&colon;&quot&semi;in-article links&quot&semi;&comma;&quot&semi;action&quot&semi;&colon;&quot&semi;link click&quot&semi;&comma;&quot&semi;label&quot&semi;&colon;&quot&semi;https&colon;&sol;&sol;press&period;fitbit&period;com&sol;press-releases&sol;press-release-details&sol;2019&sol;The-Bristol-Myers-Squibb-Pfizer-Alliance-and-Fitbit-Collaborate-to-Address-Gaps-in-Atrial-Fibrillation-Detection-with-the-Aim-of-Accelerating-Diagnosis&sol;default&period;aspx&quot&semi;&rcub;">BMS-Pfizer Alliance<&sol;a> to develop educational content for patients and healthcare providers that will help identify and support people in the U&period;S&period; with irregular heart rhythms consistent with atrial fibrillation&period;<&sol;p>&NewLine;<p>Apple&&num;8217&semi;s Watch also has a feature that can check for abnormal heart beat&period;<&sol;p>&NewLine;

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