FDA – Tekrati https://www.tekrati.com Experts' Views on Modern Business Fri, 19 Feb 2021 06:13:18 +0000 en-US hourly 1 https://wordpress.org/?v=6.9.4 https://www.tekrati.com/wp-content/uploads/2022/04/cropped-Tekrati-Guest-Posts-32x32.jpeg FDA – Tekrati https://www.tekrati.com 32 32 FDA Approves Yale’s Salivadirect Test For Public Use https://www.tekrati.com/fda-approves-yales-salivadirect-test-for-public-use/ https://www.tekrati.com/fda-approves-yales-salivadirect-test-for-public-use/#respond Mon, 24 Aug 2020 21:30:11 +0000 https://www.tekrati.com/?p=1139 FDA Approves Yale’s Salivadirect Test For Public Use

FDA Approves Yale’s Salivadirect Test For Public Use

To help test more Americans for COVID-19, the FDA approved the SalivaDirect test for public use. This test uses a person’s saliva to detect the virus. With SalivaDirect, more US citizens can get tested. SalivaDirect delivers fast results at lower prices. The US FDA approved SalivaDirect for emergency use on Saturday.  COVID-19 Testing with SalivaDirect [...]

The post FDA Approves Yale’s Salivadirect Test For Public Use first appeared on Tekrati and is written by Irene Hawkins

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FDA Approves Yale’s Salivadirect Test For Public Use

FDA Approves Yale’s Salivadirect Test For Public Use

To help test more Americans for COVID-19, the FDA approved the SalivaDirect test for public use. This test uses a person’s saliva to detect the virus. With SalivaDirect, more US citizens can get tested. SalivaDirect delivers fast results at lower prices.

The US FDA approved SalivaDirect for emergency use on Saturday. 

COVID-19 Testing with SalivaDirect

CNN reports that experts from the Yale School of Public Health created SalivaDirect. Unlike swab tests, you don’t need swabs or external collection devices with SalivaDirect. With reagents and samples, the whole kit could cost just over $10.

With SalivaDirect, Yale hopes they can help control the pandemic. The world needs to contain the virus while waiting for a vaccine. 

How Fast is SalivaDirect?

In just three hours, SalivaDirect gives you accurate results. SalivaDirect’s results are as precise as standard nasal swab tests. Yale hopes to roll out the kits to the public in the next few weeks

Since Yale plans to make its test “open-source,” other labs could use the saliva test. They just have to follow Yale’s instructions.

Currently, the NBA uses SalivaDirect for testing. It has also funded Yale’s research. 

COVID-19 Testing in the US

Fewer US states are still testing for COVID-19. Last week, seventeen states did fewer tests than previous weeks. Right now, Americans have to wait for days before getting results back.

The post FDA Approves Yale’s Salivadirect Test For Public Use first appeared on Tekrati and is written by Irene Hawkins

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US FDA Clears Samsung Galaxy Watch 3’s ECG App https://www.tekrati.com/us-fda-clears-samsung-galaxy-watch-3s-ecg-app/ https://www.tekrati.com/us-fda-clears-samsung-galaxy-watch-3s-ecg-app/#respond Thu, 06 Aug 2020 19:05:55 +0000 https://www.tekrati.com/?p=934 US FDA Clears Samsung Galaxy Watch 3’s ECG App

US FDA Clears Samsung Galaxy Watch 3’s ECG App

You can look outside the Apple Watch for on-the-go ECG monitoring. Now, the US Food and Drug Administration (FDA) has cleared Samsung’s Galaxy Watch 3 for ECG monitoring. With the clearance, Samsung and Apple are the only two smartwatch makers allowed to release ECG apps. FDA Clearance for the Galaxy Watch 3 The Verge reports [...]

The post US FDA Clears Samsung Galaxy Watch 3’s ECG App first appeared on Tekrati and is written by Sam Arnold

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US FDA Clears Samsung Galaxy Watch 3’s ECG App

US FDA Clears Samsung Galaxy Watch 3’s ECG App

You can look outside the Apple Watch for on-the-go ECG monitoring. Now, the US Food and Drug Administration (FDA) has cleared Samsung’s Galaxy Watch 3 for ECG monitoring. With the clearance, Samsung and Apple are the only two smartwatch makers allowed to release ECG apps.

FDA Clearance for the Galaxy Watch 3

The Verge reports that the FDA has given Samsung a Class II clearance. For Galaxy Watch 3 users, this clearance means you can use the watch as a medical device. You can rely on your watch to give you accurate data, which you can take to your doctor. Apple Watches had also received Class II clearances in 2018. 

As a Class II medical device, Galaxy Watches and Apple Watches are on the same level as home pregnancy tests and blood pressure cuffs. However, only Class III devices, like pacemakers, enjoy a Class III clearance.


The Galaxy Watch 3 as a Medical Tool

Federico Casalegno welcomed the FDA clearance at Samsung’s Unpacked event. At the event, he said the FDA giving the  Watch 3 a Class II clearance was exciting news. Caselegno is the Senior Vice President of Samsung.

Users can also access an ECG app in the Watch 2, but they can’t use it in the United States. The Galaxy Watch 3 takes a step closer to the Apple Watch in terms of use as health and wellness gadgets.

South Koreans Already Use the Galaxy Watch 3’s ECG app

In May, South Korea’s Ministry of Food and Drug Safety cleared the Watch 2’s ECG app for public use. It’s not yet clear when Americans can use the feature on their Watch 2s.

The post US FDA Clears Samsung Galaxy Watch 3’s ECG App first appeared on Tekrati and is written by Sam Arnold

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