Striking a Chord with Both Consumers and
With three new FDA clearances under its belt in 2019 alone, AliveCor keeps reinventing itself for modernity. It recently introduced the first and only FDA-approved personal 6-lead ECG, once again raising the bar for its peers.
By Gergana Koleva
Founder of AliveCor Dr. David Albert celebrated his 65th birthday in style by doing 65 push-ups on camera and sharing the video on LinkedIn with a message to everyone in his network to stay active, assuring them that keeping oneself young is possible at any age. The video garnered over 50,000 views in less than a week. Albert loves such challenges and is continually looking to "change the game", so much so that his philosophy of "everyone must be healthy and take more responsibility for their own health" is reflected in his creation of an innovative, game-changing product.
If all the wearable ECG device-makers of the world were to put aside their rivalries and form a “council of elders” to steer the future while drawing wisdom from the past, AliveCor might well be its chairman. When it emerged in beta mode at the Consumer Electronics Show in 2011, after a homemade YouTube video posted by its founder-to-be demonstrating a prototype of an iPhone ECG went viral, it marked the unofficial start of the remote cardiac monitoring innovation race.
A year later, Albert had founded the Mountain View-based company and gotten an FDA clearance to commercialize its first product, the AliveCor Heart Monitor. The invention consisted of sensor technology embedded into an iPhone 4/4S case that produced and showed an on-screen ECG after being placed on the fingers or held against the chest to determine the presence of arrhythmia. The pioneering concept unlocked a flood of innovation in the industry and to this day continues to serve as a reference to makers of both clinical-grade and consumer wireless cardiac devices.
The wisdom of hindsight
Mountain View, CA headquartered AliveCor is transforming cardiological care using deep learning. AliveCor's clinically valuable personal ECG devices make heart care more convenient, more accessible, and less expensive than ever before.
AliveCor´s current flagship products, a single-lead and a 6-lead mobile ECG devices, are a far cry from that first iPhone case. Not only has the company improved the underlying technology, based on over 50 million recorded ECGs worldwide, and rebranded its heart monitors – now known as the KardiaMobile and KardiaMobile 6L – but it has also fortified its newest offerings with capabilities that allow for differentiated arrhythmia diagnoses.
Namely, two of last year´s FDA clearances certified KardiaMobile as the only consumer wearable ECG device on the market able to detect bradycardia and tachycardia; the third regulatory approval recognized the KardiaMobile 6L – an advanced version of the KardiaMobile – as the first portable 6-lead ECG monitor which can also detect atrial flutter and provide superior P-waves visualization.
“We knew that 30 to 40 percent of our users whose ECGs were labelled as ´unclassified arrhythmia´ by the KardiaMobile were simply having high and low heart rate. We still want these users to go to their doctor to find out what they have, but we want to help them feel less anxious,” says Albert in explaining why AliveCor sought FDA approval for its tachycardia and bradycardia detection capabilities.
A serial entrepreneur who left a career as chief scientist of cardiology at GE in 2004 and has since founded two startups and three technology companies, including AliveCor, Albert is best known for having reimagined ECG technology. With the advent of the first palm top computer in the mid-90s, he had developed an intense interest in wireless transmission of ECGs in handheld devices and had attempted to pique the interest of colleagues by showing them prototypes and license the technology, but to no avail. After partnering and running experiments with Bruce Satchell, an Australian friend working on developing a Bluetooth ECG monitor, he founded AliveCor and with it found a home for his calling. And as his nearly 60 U.S. patents (of which 25 are pending) and more than 100 conference abstracts and publications in peer-reviewed journals attest, he hasn´t stopped innovating ever since.
From a product design standpoint, Albert´s latest technology, the KardiaMobile, consists of a sleek touchpad with two stainless steel electrodes on the top for the user´s fingers. The KardiaMobile 6L includes a third one on the bottom to be placed against the skin of the left leg (knee or ankle), for the configuration of ECG leads I, II, III, aVL, aVR, and aVF – the so called Einthoven Triangle.
The clinical utility and workflow advantages of the devices and the accompanying HIPAA-compliant, web-based KardiaPro portal – which allows patient ECG data to be connected to hospital- or physician-based electronic health records portals – have been demonstrated in clinical studies at the Mayo Clinic, the British NHS in collaboration with the University of Edinburgh, and the Cardiovascular research Foundation of Southern California.
“We spent a lot of time on ensuring that the device was completely validated by solid research, so we published a study around it ahead of our submission for FDA approval. As a result, the approval for the device took only 70 days,” says Albert, reflecting on the rewards of rigorous testing for ECG devices that blur the line between consumer and medical-grade devices. “We are now used as an example of how digital health should lead with validation and evidence-based research.”
The KardiaMobile technology consists of a sleek touchpad with two stainless steel electrodes on the top for the user´s fingers. The KardiaMobile 6L includes a third one on the bottom to be placed against the skin of the left leg (knee or ankle), for the configuration of ECG leads I, II, III, aVL, aVR, and aVF – the so called Einthoven Triangle.
As AliveCor continues to dominate the AI-based, consumer-facing remote ECG space, its business strategy has pivoted toward licensing of the technology and collaborations with corporate clients to bring devices and services to new markets.
One such partnership, indicative of the company´s increased interest in strengthening its presence in the consumer wearables niche, has been its recent alliance with Chinese smartwatch and heart tracker maker Huami. The expectation is that the collaboration will introduce entirely new ECG form factors in 2020 and deliver AliveCor’s AI-driven subscription services and solutions to enterprise customers and consumers worldwide.
Another international deal closed last year was with health service provider Beijing Dream Tree Medical Technology, which will leverage AliveCor´s technology to deliver cost-effective care to a growing number of Chinese patients who suffer from or are at elevated risk for heart disease.
Closer to home, the company has also partnered with Illinois-based Omron Healthcare over the design of Complete, the first blood pressure monitor that allows users to simultaneously monitor their ECG at home.
“AliveCor technology allows partners to easily deliver clinically validated, peer-reviewed medical features to their own customers, at scale,” AliveCor CEO Priya Abani informed the press at the partnership announcement, emphasizing the value the company´s innovations would bring to new alliances. Abani joined AliveCor last year from Amazon, where working on the Alexa team had been her latest engagement in a career spanning two decades of experience launching innovative products.
“After losing a parent last year, I started to think about working in the health care segment. The idea of transforming cardiac care was really interesting to me,” she said in an interview with CNBC last year. Abani´s decision to join AliveCor was applauded by legendary investor and chairman of the board of directors Vinod Khosla, who had roped her in for her expertise in scaling businesses, making them appealing to new consumer segments, and forging corporate partnerships.
AliveCor´s vision is to make ECGs as affordable and routine as taking blood pressure – and it knows it has a head start. Albert, who gave a presentation in 2012 on the consumerization of cardiac monitoring devices and applications of wireless connectivity for medical devices, in more recent interviews captures that succinctly:
“We’ve pioneered the consumer access to real personal cardiac health data. We´ve got a unique position: we were early and we´ve taken a right cross from the world´s biggest companies, and we still thrive. We feel pretty good about where we´ve been and where we are going.”
We’ve pioneered the consumer access to real personal cardiac health data. We´ve got a unique position: we were early and we´ve taken a right cross from the world´s biggest companies, and we still thrive. We feel pretty good about where we´ve been and where we are going.
David Albert, Founder and Interim Chief Medical Officer of AliveCor
In an age where information is a commodity, discerning the credibility of the source is everything. The companies that are relentlessly committed to providing the highest quality data, while protecting their customers’ data, will be the ones that win in this space.
Priya Abani @ JP Morgan’s Internet of Medical Things panel on The future of Digital Health