Tag: ECG

Posted on

Garmin launches a new FDA-cleared ECG app for the Venu 2 Plus

Garmin is the latest company to give its users the ability to take an ECG reading from their wrist. The company is launching a new ECG app that allows users to record their heart rhythm and check for signs of atrial fibrillation (AFib), the company announced on Tuesday.

The app, which is the company’s first FDA-cleared smartwatch feature, is available for the Venu 2 Plus in the United States. Garmin plans to add support for more devices and regions in the future, and notes that these plans require further regulatory approval.

Users can use the app to record a 30-second ECG and view their heart rhythm results immediately on the watch or at a later time in the Garmin Connect app. When users take an ECG, the new app uses sensors on the Venu 2 Plus to record the electrical signals that control how their heart beats. The ECG App then analyzes that recording to detect signs of AFib. For context, AFib rhythms occur when the upper and lower chambers of your heart are not beating in sync.

Garmin ECG app

Image Credits: Garmin

Users can also sync their results to Garmin Connect, which allows users to view their history of ECG results and create reports that can be shared with a healthcare provider.

“The ECG App is Garmin’s first FDA-cleared smartwatch feature and we are thrilled to offer this revolutionary tool to our customers as another way to stay on top of their health,” said Dan Bartel, Garmin vice president of global consumer sales, in a press release. “During the early stages of AFib, it’s common for symptoms to be infrequent, making it difficult to detect in a clinical setting. With the new ECG App, Venu 2 Plus customers can conveniently take an ECG recording anytime and optionally create a report of their results to share with their doctor later.”

As with other similar apps, Garmin’s ECG app isn’t a diagnostic tool and is instead seen as a way to get a bit more insight into your health. Google, Fitbit, Apple, Samsung and Withings smartwatches have offered ECG features for quite some time now, so Garmin’s new ECG app is a welcome addition to the Venu 2 Plus.

Garmin pops solar power onto its fancy Forerunner running watch

Garmin launches a new FDA-cleared ECG app for the Venu 2 Plus by Aisha Malik originally published on TechCrunch

Posted on

Cardiomatics bags $3.2M for its ECG-reading AI

Poland-based healthtech AI startup Cardiomatics has announced a $3.2M seed raise to expand use of its electrocardiogram (ECG) reading automation technology.

The round is led by Central and Eastern European VC Kaya, with Nina Capital, Nova Capital and Innovation Nest also participating.

The seed raise also includes a $1M non-equity grant from the Polish National Centre of Research and Development.

The 2017-founded startup sells a cloud tool to speed up diagnosis and drive efficiency for cardiologists, clinicians and other healthcare professionals to interpret ECGs — automating the detection and analyse of some 20 heart abnormalities and disorders with the software generating reports on scans in minutes, faster than a trained human specialist would be able to work.

Cardiomatics touts its tech as helping to democratize access to healthcare — saying the tool enables cardiologists to optimise their workflow so they can see and treat more patients. It also says it allows GPs and smaller practices to offer ECG analysis to patients without needing to refer them to specialist hospitals.

The AI tool has analyzed more than 3 million hours of ECG signals commercially to date, per the startup, which says its software is being used by more than 700 customers in 10+ countries, including Switzerland, Denmark, Germany and Poland.

The software is able to integrate with more than 25 ECG monitoring devices at this stage, and it touts offering a modern cloud software interface as a differentiator vs legacy medical software.

Asked how the accuracy of its AI’s ECG readings has been validated, the startup told us: “The data set that we use to develop algorithms contains more than 10 billion heartbeats from approximately 100,000 patients and is systematically growing. The majority of the data-sets we have built ourselves, the rest are publicly available databases.

“Ninety percent of the data is used as a training set, and 10% for algorithm validation and testing. According to the data-centric AI we attach great importance to the test sets to be sure that they contain the best possible representation of signals from our clients. We check the accuracy of the algorithms in experimental work during the continuous development of both algorithms and data with a frequency of once a month. Our clients check it everyday in clinical practice.”

Cardiomatics said it will use the seed funding to invest in product development, expand its business activities in existing markets and gear up to launch into new markets.

“Proceeds from the round will be used to support fast-paced expansion plans across Europe, including scaling up our market-leading AI technology and ensuring physicians have the best experience. We prepare the product to launch into new markets too. Our future plans include obtaining FDA certification and entering the US market,” it added.

The AI tool received European medical device certification in 2018 — although it’s worth noting that the European Union’s regulatory regime for medical devices and AI is continuing to evolve, with an update to the bloc’s Medial Devices Directive (now known as the EU Medical Device Regulation) coming into application earlier this year (May).

A new risk-based framework for applications of AI — aka the Artificial Intelligence Act — is also incoming and will likely expand compliance demands on AI healthtech tools like Cardiomatics, introducing requirements such as demonstrating safety, reliability and a lack of bias in automated results.

Asked about the regulatory landscape it said: “When we launched in 2018 we were one of the first AI-based solutions approved as medical device in Europe. To stay in front of the pace we carefully observe the situation in Europe and the process of legislating a risk-based framework for regulating applications of AI. We also monitor draft regulations and requirements that may be introduced soon. In case of introducing new standards and requirements for artificial intelligence, we will immediately undertake their implementation in the company’s and product operations, as well as extending the documentation and algorithms validation with the necessary evidence for the reliability and safety of our product.”

However it also conceded that objectively measuring efficacy of ECG reading algorithms is a challenge.

“An objective assessment of the effectiveness of algorithms can be very challenging,” it told TechCrunch. “Most often it is performed on a narrow set of data from a specific group of patients, registered with only one device. We receive signals from various groups of patients, coming from different recorders. We are working on this method of assessing effectiveness. Our algorithms, which would allow them to reliably evaluate their performance regardless of various factors accompanying the study, including the recording device or the social group on which it would be tested.”

“When analysis is performed by a physician, ECG interpretation is a function of experience, rules and art. When a human interprets an ECG, they see a curve. It works on a visual layer. An algorithm sees a stream of numbers instead of a picture, so the task becomes a mathematical problem. But, ultimately, you cannot build effective algorithms without knowledge of the domain,” it added. “This knowledge and the experience of our medical team are a piece of art in Cardiomatics. We shouldn’t forget that algorithms are also trained on the data generated by cardiologists. There is a strong correlation between the experience of medical professionals and machine learning.”

As clinical guidelines shift, heart disease screening startup pulls in $43M Series B

Apple launched a study to look for irregular heart rhythms on the Apple Watch

Posted on

AliveCor, which helps its users manage their heart health, scores another FDA approval

Last week, AliveCor, a nine-year-old, 92-person company whose small, personal electrocardiogram devices help users detect atrial fibrillation, bradycardia, and tachycardia from heart rate readings taken from their own kitchen tables, raised $65 million from investors.

Today, it’s clearer why investors — who’ve now provided the Mountain View, Ca., company with $169 million altogether —  are excited about its prospects. AliveCor just received its newest FDA clearance under the agency’s software as a medical device designation for an upgrade that generates enough detail and fidelity that AliveCor says its cardiological services can now serve as stand-in for the vast majority of cases when cardiac patients are not in front of their doctor.

Specifically, the company says the FDA-cleared update can detect premature atrial contractions, premature ventricular contractions, sinus rhythm with wide QRS.

In a world where the pandemic continues to rage and people remain hesitant to visit a hospital, these little steps add up. In fact, CEO Priya Abani, along with AliveCor founder and chief medical officer David Albert, formerly the chief clinical scientist of cardiology at GE, say AliveCor’s “Kardia” devices have been used to record nearly 15 million EKG recordings since March of this year, which is up over 70% year-over-year.

They also claim a 25% increase year-over-year in what they call physician-patient connections, meaning doctors specifically asking their patients to use the device, either at their medical office or at the patient’s home. Indeed, the pair says that while the company has focused historically on consumer sales, so much new business is coming through doctor referrals that roughly one out of every two of its devices is now sold through these recommendations.

Patients still need to pay out of pocket for AliveCor’s personal EKG devices, one of which currently sells for $89 while a more sophisticated model sells for $139.

The company also more recently rolled out a subscription product for $99 per year that “unlocks” additional features, including monthly summaries of a customer’s heart data, and hopefully soon, says Abani, access to cardiologists who will be able to answer questions in lieu of one’s own cardiologist.

Abani — who joined AliveCor last year from Amazon, where she was a general manager and director of Alexa — says other offerings are also in the works that should help customers measure their hypertension and blood pressure. She adds that the company more broadly sees itself as becoming a way for people to manage chronic conditions from home and that, if things go AliveCor’s way, employers will begin offering the service to employees as a way for them to take better care of their own heart health.

In the meantime, AliveCor’s bigger push into the enterprise appears tied not only to COVID and its ripple effects but also to competition on the consumer front from Apple Watch, which also now enables wearers to records the electrical pulses that make one’s heart beat and to determine whether the upper and lower chambers are their heart are in rhythm.

Though the company has sung Apple’s praises for raising awareness around heart health, last year, owing to shrinking sales, AliveCor stopped making an earlier product called the KardiaBand that was an FDA-cleared ECG wristband designed for use with Apple Watches.

AliveCor’s products are currently sold in 12 countries, including India, South Korea, and Germany, and it has clearance to sell in more than 37 altogether.

In addition to selling directly to customers through its site, its devices are available to buy through Best Buy, CVS, and Walgreens.

Very worth noting: Neither Apple nor AliveCor can detect actual heart attacks. While both can detect atrial fibrillation, acute heart attacks are not associated with atrial fibrillation.