Digital health technology company Qardio, based out of San Francisco, received FDA approval for a new health product this week.
The QardioArm 2.0 is probably the next-generation model of the company’s popular QardioArm line of blood pressure measurement devices.
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QardioArm 2’s FDA 510(k) clearance
We are not sure about the detailed specifications of the new model. The listing was spotted this week.
The existing QardioArm unit is one of the popular models out there that many customers favor due to its attractive price point and integration with Apple Health.
QardioArm wireless blood pressure monitor measures your systolic, diastolic blood pressure, and heart rate and detects irregular heartbeat. It is FDA cleared and clinically validated to meet the US and European Standards.
QardioArm is FSA and HSA eligible (Flexible Spending Account, Health Savings Account).
QardioArm devices also integrate well with Amazon Alexa. The new Qardio Alexa Skill for Amazon Alexa is available on all Amazon devices that support Alexa, including the Amazon Echo and Echo Plus, Echo Spot, Echo Show, Echo Dot, and Fire tablets.
Given the price point of $99, the existing QardioArm is still a good buy for those suffering from hypertension issues. We will keep an eye on any exciting announcements from Qardio about this new model and will keep the post updated.
About the FDA’s 510(k) clearance process
Section 510(k) of the FDA (Food, Drug, and Cosmetic Act) requires device manufacturers to register and notify the FDA of their intent to market a medical device at least 90 days in advance. This process is known as Premarket Notification–also called PMN or 510(k).
The FDA then reviews the submitted device and determines whether this new device is equivalent to a device already placed into one of the three classification categories of Class 1, Class 2, or Class 3 medical devices.