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		<title>MFDS &#8211; Samsung Global Newsroom</title>
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				<title>Samsung Brings Irregular Heart Rhythm Notification to Galaxy Watch in 13 Markets</title>
				<link>https://news.samsung.com/global/samsung-brings-irregular-heart-rhythm-notification-to-galaxy-watch-in-13-markets</link>
				<pubDate>Wed, 14 Jun 2023 22:00:32 +0000</pubDate>
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				<dc:creator><![CDATA[Samsung Newsroom]]></dc:creator>
						<category><![CDATA[Mobile]]></category>
		<category><![CDATA[Press Release]]></category>
		<category><![CDATA[Galaxy]]></category>
		<category><![CDATA[Galaxy Wearable]]></category>
		<category><![CDATA[IHRN]]></category>
		<category><![CDATA[MFDS]]></category>
		<category><![CDATA[One UI 5]]></category>
		<category><![CDATA[One UI 5 Watch]]></category>
		<category><![CDATA[Samsung Health]]></category>
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									<description><![CDATA[Samsung Electronics today announced that the Irregular Heart Rhythm Notification (IHRN) feature1 on the Samsung Health Monitor app2 will soon be available in 13 markets starting this summer. Combined with the app’s Blood Pressure3 and Electrocardiogram (ECG)4 monitoring, the IHRN feature detects heart rhythms suggestive of atrial fibrillation (AFib), helping Galaxy Watch users understand their […]]]></description>
																<content:encoded><![CDATA[<p><img class="alignnone size-full wp-image-142162" src="https://img.global.news.samsung.com/global/wp-content/uploads/2023/06/IHRN-Notification_Galaxy-Watch_PR_main1.jpg" alt="" width="1000" height="455" /></p>
<p>Samsung Electronics today announced that the Irregular Heart Rhythm Notification (IHRN) feature<sup>1</sup> on the Samsung Health Monitor app<sup>2</sup> will soon be available in 13 markets starting this summer. Combined with the app’s Blood Pressure<sup>3</sup> and Electrocardiogram (ECG)<sup>4</sup> monitoring, the IHRN feature detects heart rhythms suggestive of atrial fibrillation (AFib), helping Galaxy Watch users understand their heart health more comprehensively.</p>
<p>The IHRN feature has been approved by the Korean Ministry of Food and Drug Safety (MFDS) last week, following recent <a href="https://news.samsung.com/global/samsung-announces-fda-cleared-irregular-heart-rhythm-notification-for-galaxy-watch" target="_blank" rel="noopener">clearance by the U.S. Food and Drug Administration (FDA)</a>. It will also be introduced in Argentina, Azerbaijan, Costa Rica, Dominican Republic, Ecuador, Georgia, Guatemala, Hong Kong, Indonesia, Panama, UAE, as well as Korea and the U.S., taking the total to 13 markets.</p>
<p>Alongside the on-demand ECG tracking, the IHRN feature checks for irregular heart rhythms in the background and warns the user of potential AFib activity. Together with the existing Blood Pressure and Heart Rate<sup>5</sup> monitoring, users can gain even deeper insights into their cardiovascular health.</p>
<p>Since the launch in 2020, the Samsung Health Monitor app has expanded to 74 markets<sup>6</sup> across the globe. Over 15 million Galaxy Watch users have kept track of their blood pressure and ECG right from their wrist, gaining a better picture of their heart health by continuously monitoring and recording their blood pressure and heart rhythms.</p>
<p>“Cardiovascular disease remains one of the main causes of death around the world, and we’re committed to empowering our users to stay informed about their heart health by providing monitoring tools, including blood pressure measurement and irregular heart rhythm notification,” said Hon Pak, Vice President and Head of Digital Health Team, MX Business at Samsung Electronics. “We’re constantly exploring new ways to help Galaxy Watch users obtain deeper insights on their health and wellness effortlessly, day and night.”</p>
<p>The Irregular Heart Rhythm Notification feature will first be available on the upcoming Galaxy Watch devices later this year, as part of the new <a href="https://news.samsung.com/global/better-sleep-better-health-new-one-ui-5-watch-shows-first-look-at-upcoming-galaxy-watch" target="_blank" rel="noopener">One UI 5 Watch</a> and later expanded to previous editions.<sup>7</sup></p>
<p><span style="font-size: small"><em><sup>1</sup> The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present. It is not intended for users with other known arrhythmias.<br />
<sup>2</sup> Availability may vary by market or device. Due to market restrictions in obtaining approval/registration as a Software as a Medical Device (SaMD), it only works on watches and smartphones purchased in the markets where service is currently available (however, service may be restricted when users travel to non-service markets). This app can only be used for measuring in ages 22 and over.<br />
<sup>3</sup> The Blood Pressure feature is only available in select markets. To ensure accuracy, users should calibrate their device every four weeks with a traditional blood pressure cuff. The BP feature cannot diagnose hypertension, other conditions or check for signs of a heart attack. It is not meant to replace traditional methods of diagnosis or treatment by a qualified healthcare professional.<br />
<sup>4</sup> The ECG feature is only available in select markets. It is not intended to replace traditional methods of diagnosis or treatment. The feature is not intended for users with known arrhythmias other than AFib. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.<br />
<sup>5</sup> Supported via Samsung Health app. The feature is intended for general wellness and fitness purposes only. Not intended for use in detection, diagnosis or treatment of any medical condition or disease. Availability may vary by market or device.<br />
<sup>6</sup> Available in Argentina, Australia, Austria, Azerbaijan, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, Christmas Island, Cocos (Keeling) Islands, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Honduras, Hungary, Iceland, Indonesia, Israel, Ireland, Italy, Korea, Latvia, Lithuania, Luxemburg, Macau, Malaysia, Malta, Mayotte, Mexico, Netherlands, New Zealand, Nicaragua, Norfolk Island, Norway, Panama, Paraguay, Peru, Philippines,  Poland, Portugal, Réunion, Romania, Russia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Türkiye, U.K., Ukraine, UAE, U.S., Venezuela and Vietnam.<br />
<sup>7</sup> Availability may vary by market, carrier, model or a paired smartphone. Available on Galaxy Watch4 series and later models.</em></span></p>
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					<item>
				<title>Samsung Announces Blood Pressure Monitoring Application for Galaxy Watch Devices</title>
				<link>https://news.samsung.com/global/samsung-announces-blood-pressure-monitoring-application-for-galaxy-watch-devices</link>
				<pubDate>Tue, 21 Apr 2020 11:19:35 +0000</pubDate>
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				<dc:creator><![CDATA[Samsung Newsroom]]></dc:creator>
						<category><![CDATA[Mobile]]></category>
		<category><![CDATA[Blood Pressure Monitoring Application]]></category>
		<category><![CDATA[Galaxy Watch]]></category>
		<category><![CDATA[Galaxy Watch Active2]]></category>
		<category><![CDATA[Galaxy Watch Devices]]></category>
		<category><![CDATA[Heart Rate Monitoring Sensors]]></category>
		<category><![CDATA[MFDS]]></category>
		<category><![CDATA[SaMD]]></category>
		<category><![CDATA[Samsung Health Monitor App]]></category>
		<category><![CDATA[Software as a Medical Device]]></category>
		<category><![CDATA[South Korea’s Ministry of Food and Drug Safety]]></category>
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									<description><![CDATA[Samsung Electronics announced today that the Samsung Health Monitor app has been cleared by South Korea’s Ministry of Food and Drug Safety (MFDS), as a Software as a Medical Device (SaMD), making it a government-cleared, over-the-counter and cuffless blood pressure monitoring application. The Samsung Health Monitor app, when paired with advanced sensor technology on the […]]]></description>
																<content:encoded><![CDATA[<p>Samsung Electronics announced today that the Samsung Health Monitor app has been cleared by South Korea’s Ministry of Food and Drug Safety (MFDS), as a Software as a Medical Device (SaMD), making it a government-cleared, over-the-counter and cuffless blood pressure monitoring application. The Samsung Health Monitor app, when paired with advanced sensor technology on the Galaxy Watch Active2,<sup>1</sup> enables you to easily and more conveniently measure and track your blood pressure.</p>
<p>Globally, high blood pressure is known to significantly increase your risk of brain, kidney and heart diseases, including stroke and coronary heart disease when not managed properly. By helping users measure and track their blood pressure, the Samsung Health Monitor app gives people greater insight into their health and allows them to make more informed decisions, to lead healthier lives.</p>
<p>“The Samsung Health Monitor app has the potential to help millions of people around the world who are affected by high blood pressure,” says Taejong Jay Yang, Corporate SVP and Head of Health Team, Mobile Communications Business at Samsung Electronics. “This is one of many examples of how Samsung is integrating its best-in-class hardware with the latest software innovations to innovate mobile experiences.”</p>
<p>Once your Galaxy Watch Active2 device has been calibrated with a traditional cuff, you can simply tap to “Measure” your blood pressure anytime, anywhere. The device measures blood pressure through pulse wave analysis, which is tracked with the Heart Rate Monitoring sensors. The program then analyzes the relationship between the calibration value and the blood pressure change to determine the blood pressure.<sup>2</sup> To ensure accuracy, users are required to calibrate their device at least every four weeks.</p>
<p>With the addition of blood pressure monitoring, the Galaxy Watch Active2 boasts Samsung’s most advanced health and wellness capabilities yet. The Galaxy Watch Active2 comes with more sensitive and accurate Heart Rate Monitoring sensors, and enables users to track their exercise, sleep, stress and get added healthcare insights that can help you improve your wellbeing.<sup>3</sup></p>
<p>The Samsung Health Monitor app will be available on the Galaxy Watch Active2 within the third quarter <span>and</span><span> will progressively expand to upcoming Galaxy Watch devices.</span></p>
<p><img class="alignnone wp-image-116127" src="https://img.global.news.samsung.com/global/wp-content/uploads/2020/04/Samsung-Health-Monitor_main.gif" alt="" width="1000" height="563" /></p>
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<p><span style="font-size: small"><sup>1</sup> <em>Requires Galaxy smartphone, running Android N OS or above and Galaxy Watch Active2 or upcoming Galaxy Watch device(s) to be paired.</em></span></p>
<p><span style="font-size: small"><sup>2</sup> <em>Users should measure their blood pressure when at rest, as they would do with a traditional cuff, and refrain from measuring when they are working out, smoking or drinking.</em></span></p>
<p><span style="font-size: small"><sup>3</sup> <em>Availability may vary by market.</em></span></p>
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