Alivecor’s CardiaAI Receives 510(k) clearance and secures $65 million financing

Alivecor KardiaAI

Alivecor’s KardiaMobile and Kardiastation products are one of the most popular products for users who are looking for a medical-grade product that can help detect atrial fibrillation, Bradycardia, Tachycardia, or normal heart rhythm.

The company just received FDA clearance for its KardiaAI product.

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About Kardiamobile and KardiaAI

Alivecor’s single-lead ECG device, Kardiamobile has been a popular device for users who regularly monitor their heart health.

Starting last year, Alivecor invested heavily in its R&D and launched the new KardiaMobile 6L. 

The new 6L is the only FDA-cleared personal 6-lead EKG device available out there.

Cardiologists say that there is an enormous range of evaluations made available via the new 6L product that was not previously available using only a single lead ECG.

The company has also been making advances in the field of machine learning algorithms and launched its KardiaAI offering.Alivecor KardiaAI gets clearance

The company just received a 510(k) clearance on its KardiaAI offering last week.

Investing in AI and machine learning for future products

In regard to the need for multiple 510(k) clearances, it appears that the company is implementing a strategic approach toward incorporating its algorithm into future products.

Want or need a medical-grade device to detect atrial fibrillation, Bradycardia, Tachycardia, or normal heart rhythm?

If you are looking for a medical-grade EKG device that provides the best insights and a platform that helps you monitor your heart health, you should definitely check out the new 6L offering from AliveCor.

KardiaMobile 6-Lead Personal EKG Monitor – Six Views of The Heart – Detects AFib and Irregular Arrhythmias – Instant Results in 30 seconds – Works with Most Smartphones - FSA/HSA Eligible
  • ACCURATE AND DETAILED EKG RESULTS. KardiaMobile 6L records a medical-grade, six-lead EKG and...
  • SIX LEADS, SIX TIMES THE DATA. Six-lead EKGs give you a more detailed view of your heart and more...

We expect to see more enhancements and new features to the new KardiaCare membership platform.

Currently, the new KardiaCare platform offers some of these features:

  • EKG review every 90 days by a board-certified cardiologist.
  • Monthly heart health report that summarizes all of your EKG recordings. Share it with your doctor, or use it to track your heart health over time.
  • Automatic sharing of your EKGs with family or caregivers using Inner Circle.

More news in the AI health space

Alivecor today announced its $65 million Series E financing led by existing investors OMRON, Khosla Ventures, WP Global Partners, Qualcomm Ventures, and Bold Capital Partners.

The company’s AI-powered ECG determinations will be augmented with telehealth services, as well as with detection and condition management services for providers and institutions.

The enhanced partnership with OMRON will also position the company to include hypertension management within its service portfolio.

“We are grateful for the continued confidence of our investors,” said Priya Abani, CEO of AliveCor.

“This financing speaks to the transformative power our technology brings to the healthcare system. We remain positioned to fulfill our vision of delivering AI-based, remote cardiological services for the vast majority of cases when cardiac patients are not in front of their doctor.”


With Apple, Withings, and a handful of other fitness and wellness device makers steadily making their push into consumer-grade cardiac monitoring, AliveCor is looking to differentiate itself as a more robust offering that can meet the needs of both patients and healthcare providers.

It’s an exciting time in the health, technology, and wearable fields! We can’t wait to see what the future pipeline produces.

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Sudz Niel Kar
I am a technologist with years of experience with Apple and wearOS products, have a BS in Computer Science and an MBA specializing in emerging tech, and owned the popular site AppleToolBox. In my day job, I advise Fortune 500 companies with their digital transformation strategies and also consult with numerous digital health startups in an advisory capacity. I'm VERY interested in exploring the digital health and fitness-tech evolution and keeping a close eye on patents, FDA approvals, strategic partnerships, and developments happening in the wearables and digital health sector. When I'm not writing or presenting, I run with my Apple Watch Ultra or Samsung Galaxy Watch and closely monitor my HRV and other recovery metrics.


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