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CES 2021: New device listens to heart, measures ECG remotely - TechRepublic

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HD Medical debuted a new device that it says can revolutionize remote cardiac healthcare.

CES 2021 must-read coverage

TechRepublic's Karen Roby spoke with Arvind Thiagarajan, CEO of HD Medical, about a new heart monitoring device his team is demonstrating at CES 2021. The following is an edited transcript of their conversation.

Arvind Thiagarajan: This'll be our first year at CES. We usually participate in a lot of medical shows because our earlier products were all catered towards the physicians. But this is the first time we are really excited to launch our new patient product, the consumer product.

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Karen Roby: All right, Arvind. Let's get right down to it. The device that you guys will be talking about this week and explaining and demonstrating to everyone that you say is really a game-changer.

Arvind Thiagarajan: I'm with HD Medical, we are all about saving lives with early diagnosis, and I'm, again, Arvind Thiagarajan, founder and CEO of the company. And we are focused on solving this huge problem of cardiovascular disease, which is an epidemic, truly. Almost 18 million people die worldwide. And in America alone, almost 2,000 people die every day [from heart disease]. The reason for that is auscultation, the art of listening using a stethoscope, is a dying art. And then the second problem is that the ECG and echocardiograms, which are better technologies, but they are not routinely done unless symptoms show up. And the problem is, when the symptoms show up, the patient is not with the physician. And when the patient is with the physician, the symptoms, unfortunately, don't show up. That's why there are so many deaths.

healthyu-pr-image.jpg

Image: HD Medical

We wanted to solve this problem in two phases. The first phase was our solution for the physicians where we launched the world's first intelligent stethoscope [HD Steth] with integrated ECG leads. And this device has the ECG leads, the three golden dots, so it shows the ECG in green color, and then heart zones in blue, and any murmurs in orange color. This was FDA cleared last year in July 2020, this was FDA clear and we already started sales in the US and worldwide for this product, it's getting tremendous traction worldwide.

But we are super excited about the next phase of our solution, which is for the home patient. So we've got HealthyU which is the world's first intelligent all-in-one remote patient monitoring device for the home consumer. We want to make it so easy to use that even a grandma at home, without any training, can just simply put it on and use it without any wires or anything like that. So what this device does is that it's a very small little device, you can literally hold it in your hand, and this is how small it is.

It integrates all these parameters, what I've listed here on the left, starting with 7-Lead ECG, which is the highest in the industry, stethoscopes, heart rate, pulse oximeter, temperature, blood pressure, and respiration rate. I mean, imagine whatever we have on a stethoscope, a ECG, and the patient monitoring in the ICU, in the hospital, that's what you can have it in your pocket. This is going to change the future of telehealth and home monitoring. It's so easy to use, you just have to literally take this, Karen, and put it on with your four fingers, just like what I'm showing here and what you see on the screen. And that's it, it just has to make contact with the skin, and that's it. No training required, no wires, nothing.

And it has the ECG leads, the pulse-ox and blood pressure, heart sounds and lung sounds, everything in it, and the patient can just hold on to it, and they can see all the parameters on their device screen itself and also blood pressure and things like that. They can also connect this to a platform, which I'll show you in a minute. But this is just to give you a bit of a closer view of the device. I mean, right now, HealthyU is a little too healthy, we are going to put it on a diet, hopefully, in the next few weeks, and thin it down, if required, but our advisor says, "Don't make it too small, the older patients may drop it and lose it."

It's got a USB-C connector for charging and so on, and then also an audio connector. You can take the audio out and connect to a Zoom meeting, like this, and enable a doctor on the other side to listen to your heart zones and ausculte, so that's possible. More than that, it can actually connect to a platform, a software which the live demo you will see, but just to give you a feel for it, this is the stethoscope interface where you will see the heart sounds, the lub-dub sounds, and the ECG in green color, and so on. And if the doctor on the other side wants to look at the seven-lead ECG, then they can actually look at this and you can see the seven lead ECG.

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This is a game changer because today the highest in the industry is six-leads, and for that, you got to bend down, touch your leg, and things like that, or connect any wires. For a device without any wires, 7-lead, this is the highest in the industry, and this can change the way cardiac care is delivered at the home, because it can truly provide instant cardiac insight. And this can be life-saving, and we have benchmarked it with standard quality ECG machines, the performance is really good.

And with this, we are going to expedite our FDA clearance for this device. We are currently making this available for our partners for clinical evaluations under IRB protocol right now in this quarter. But hopefully, by second or third quarter [2021], we will have the FDA clearance in the US and make it available for home users to buy this or get it prescribed. But in Asia and other markets, we are going to start sales from next quarter onwards.

healthyu-device-with-hand2.jpg

Image: HD Medical

And this is what it does. It makes the remote patient monitoring use case really, really simple and easy to use. For starters, during the pandemic times, it enables connectivity. And even beyond the pandemic times, for telehealth and e-consultation, remote cardiac monitoring, and post-cardiac surgery. Today, the biggest expense to the health systems is the readmissions within 30 days after a surgery is done. We can actually cut that down significantly by having this device monitoring you at home. Then all these major adverse cardiac effects, like even myocardial infarctions or heart failure, and Dr. Nelson Schiller from UCSF believes, HealthyU you cannot only save lives, but it can greatly improve the quality of lives of his patients. That's where it's a game changer, it can truly revolutionize how home care is delivered, even to a grandma at home. That's where we really believe HealthyU is all about a happy you. It can really save lives and change the way our care is delivered.

We actually made this possible with our own technology, the HD Steth device, which had all the heart sounds and the ECG sensors integrated into it. It had multiple processors integrated into it. One of our key investors and technology partners is this company called Maxim Semiconductors, and we've integrated four process into the device, but with their help, and also, we have integrated additional sensors, optical sensors, and so on, that are additional ECG leads. So with this, now you have the original sensors from our previous device, which was FDA cleared, and then additional ECG leads and the optical sensors. That makes it possible to have all these integrated into one small little device. That's the tech behind it. With this connected to the platform, you have a lot of artificial intelligence (AI)-based diagnosis done. Even if you don't use our platform, you can connect through a Zoom like system and the doctor on the other side can view what's happening with this patient's conditions.

Imagine now you are Dr. Karen, and you're looking at your remote patient, and this is what it'll happen, and you'll log in securely through a HIPAA-compliant platform. Then once you log in, you can actually pair the device through Bluetooth, which will be more seamless, it'll automatically get paired in future, but right now, they got to manually pair the device on Bluetooth. Just give it a second or two. And it's scanning for the Bluetooth. Yes. They found the HealthyU device. It paired it, and now, within a few seconds, you will start seeing the heart sounds. There we go. The blue heart sounds on top, and then the ECG in green at the bottom. And then the doctor can connect their HD Steth device or any other stethoscope to listen to the heart sounds that they want.

And then the next one is the 7-lead ECG on the app there. So guys, you want to go to the 7-lead ECG? Yeah, that's great. You will see the 7-lead ECG and they can scroll down from lead one, lead two, lead three, aVL, aVR, aVF, and ECG vector leads, which you can potentially move from V1 to V6. You can actually get all 12 lead ECGs, sequentially, but simultaneously, you can get up to seven, and that's more than plenty for a home diagnosis use case. You get the 7-lead ECG, and then you also get the parameters. Even if their doctor's not connected live, he can go offline later, securely log in and see each patient, open it and then see all the readings and so on. So this really changes the game in terms of how healthcare is practiced and delivered.

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