Home All Stories COMPANY SCORES ANOTHER FDA CLEARANCE FOR ITS HEART MONITORING TECH

COMPANY SCORES ANOTHER FDA CLEARANCE FOR ITS HEART MONITORING TECH

Kardia device next to a symbol of heart rate

The US FDA recently awarded AliveCor a clearance for its heart monitoring device and app, Kardia, per a press release. 

The company’s services, an app, Kardia, and its devices act as a personal ECG device. 

According to a TechCrunch report, the FDA just cleared the company under its new FDA clearance for software as a medical device. 

Meaning, it has undergone FDA’s 510 (k) clearance providing “detail and fidelity” to the product. 

It also means AliveCor’s devices and apps can now serve as substitutes for cardiac patients to monitor their hearts’ status even without their doctors. 

Last year, the FDA also gave the company its second and third clearance for the company’s personal ECG device. 

Who is AliveCor and What is Kardia? 

AliveCor, an AI and medical device company.

Per the company’s press release, “Kardia AI V2 is the most sophisticated AI ever brought to personal ECG.” 

Moreover, it makes use of “algorithms and visualization.”

The company’s services (the Kardia app and its devices) allow users to take ECG on their own and receive instant verification of their cardiac situation. 

For example, Kardia can detect premature atrial fibrillation, bradycardia, Tachycardia, or a normal heart rhythm, per the company’s description. 

After getting those readings, the person using the device can email them to their doctors for monitoring and review. 

Just last week, several investors have provided the company a $65 million funding.

The investment would give the company a boost domestically and internationally.  

What it Means

It means that people can now save time and money from regularly going to the hospital for ECG services. Especially now, during the pandemic where hospitals and medical practitioners, most of the time, are already overloaded with patients. 

Also, it lessens people’s fear (especially the elderly) of going to the hospital or going outside because they might contract the virus. 

It also means the patients themselves, with the help of their doctors, can monitor their cardiac condition daily.

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