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False claims and misleading wording in the world of personal health apps

Last week the FDA issued a warning about certain applications and wearables that claim to measure blood glucose levels. The warning was clear: if the application is not FDA approved, it’s not safe. Since 2014, numerous applications have emerged (and sold well) that claim to monitor health concerns that the public is interested in like glucose, heart rhythm, blood pressure etc. Some of these achieved FDA clearance, but the vast majority did not.

A class of application that is particularly concerning are so called heart-health checkers. These involve placing your finger over the camera lens of your phone, or wearing a ring or other wearables that talk to your phone and claim to tell you if your “heart is healthy”. These are (for the very large part) making false claims. Like blood glucose level, heart health measurement is a sophisticated process that depends on diagnostically rich underlying data. Your ring may be able to sense a rough pulse (about the same as what you could do with your finger and a stopwatch), but you should not rely on it to tell you (for instance) anything about having a heart attack. Heart attacks are something that people have been trained to worry about, so many of us are attracted to the idea that we can purchase a device or application that will tell us if we are having one. This is why we see false claims or misleading wording about cardiac health detection in ads promoted on social all the time. Similarly, unless you are wearing a high-quality blood pressure cuff attached to your phone, there is almost no chance any phone application is providing anything more than a guess at your blood pressure, and this low fidelity measurement certainly won’t be an indicator of any kind for overall heart health. Once again the easiest thing to look for is FDA approval for the claims that are being made.

An app that collects diagnostic data for the purpose of medical assessment requires that it be cleared by the FDA as a class II medical device. An app that provides medical reports or feedback of any kind about your physical health most definitely requires FDA clearance through a rigorous and lengthy process. Not only do the producers of these applications need to prove the science behind their device works, but they must also validate it with clinical studies. Even then, they need to prove their companies have rigorous risk assessment and quality management controls to ensure that their device continues to work safely and as indicated, even after being sold.

The mandate is to ensure that people are in no way harmed by the use of the device, or app, or test. For instance an application cannot claim to tell you if you are having a heart attack or not. For the FDA to approve such a claim, the producer of the application would have to prove that accuracy of the device (for heart attack detection) is extremely high. The provider would need to clinically demonstrate a very low probability of producing a false negative result. A false negative, might erroneously convince a user that they are in fact NOT having a cardiac issue and prevent them from otherwise seeking immediate care they actually need. Diagnosing heart attacks is something that needs to be done by qualified doctors using specialized tests and equipment in a diagnostic path. These tests often involved multi-lead ECGs, blood tests, echocardiograms, CTs MRIs or angiograms. In most cases no single test is definitive and there are multiple classes of heart attack that can manifest differently. Protecting the patient is not just limited to the accuracy of a device or the underlying science, it also increasingly involves considerations for cyber security: If electronic devices can be hacked, or the data stolen, or the device functionality compromised, that also represents a risk to the public. The FDA has clear (and equally rigorous) guidelines for such things.

A properly cleared device or application makes specific, clear, and carefully worded statements about what is can and cannot do. The ability of any application to make such claims is limited by the data it can reliably collect. For instance an ECG on your watch, is good at collecting a small slice of your hearts electrical activity, but it can’t claim to replicate the diagnostic ability of a multi-lead system wired to your chest with an expert to interpret the output. Responsible producers of these devices make this clear. The FDA has a webpage where they publish some of the warning letters to companies who are making misleading, unproven or false claims

Feedback from the field

Dr. Anna Shkreba – cardiologist: “Very soon after I tried Stethophone, I started it using daily in my practise. The sound quality is extremely high. I now also have the ability to record, listen and analyze sounds anytime later, as well as to compare data to track disease regression or treatment response.”

“Stethophone significantly improved my approach to examining of new patients, especially those who have latent symptoms. It was surprising for me not only to hear high quality sound, but to see it also. Because of Stethophone, I have been able to detect refined details, consequently, patients receive their diagnosis quicker and don’t have to go through repeated cycles of consultations and examinations. 

Using Stethophone is valuable  for both the doctor and the patient and easy to get used to.I see my patients are more relaxed and have a sense of greater security with Stethophone

Welcome to Stethophone

Earlier today, Sparrow Bioacoustics launched a product into the US App Store. We think this represent a new level of offering in the consumer medical and healthcare space.

It’s called Stethophone, and it belongs to a class of product called Software As a Medical Device (SAMD). Stethophone is a class II, FDA cleared application. The first of its kind to be cleared by the FDA for consumer use.

Stethophone is a software application that converts your Smartphone into a medical grade stethoscopic device. Quite simply your phone can now listen to your heart and lungs and record that signal anywhere any time. No gadgets no attachments nothing new to charge or wear.

Using sound to assess the condition of your heart and lungs is not new. In the last two hundred  years doctors leaned how to “hear” dozens of diseases. Sound is extremely rich in diagnostic information. It tells us a great deal about the structural and rhythmic condition of the heart. In many cases it can help doctors catch diseases early – before they progress. Cardiovascular disease is the number one cause of death. CVD kills 5x as many women as breast cancer. Often, it is missed until it’s too late.

So we at Sparrow gathered a team of engineers, bio-acousticians, doctors, and researchers and decided to create a new kind of product. We wanted to see if we could turn the world’s smartphones into cardiac and pulmonary auscultation devices: making collecting diagnostic information about  your heart as easy as using a home thermometer. It will evolve quickly into a system smart enough to help detect disease at scale.

The rational was simple, your doctor can’t always be there – and symptoms and concerned happen at home. That is where you need to capture  the data.

We want to give people a medically powerful way to do this, and to use the data to get better and faster care. Our goal is to help a million people and beyond. Our sound algorithms make Stethophone of one of the finest stethoscopic devices on the market.  But we are not stopping there. We are teaching machines 200 years of auscultation using with what will soon be the largest  database of human chest sounds in history; so they can help identify anomalies that even doctors can’t always here.

Today is culmination of years of work by dedicated experts, thousands of steps in testing and refinement and regulatory, and great support from our investors, partners, and friends.

Stehophone is off to a great start. Our pilot efforts in Ukraine have involved thousands of people and helped save a few lives. And now, we are available in the US to help people listen and record their heart and lungs at home.  It’s been a long road, but this is still only the first step. The challenge now is fitting it into people’s lives in way that helps them and their doctors now and in the future. In the months ahead, we are listening and watching very closely as we continue to invest, add-value and refine our offering. Stethophone represents our belief that  people can participate more in their own care. When people have real empirical medical data to engage with the health care system it gives them more agency, peace of mind and often better outcomes.

Follow this link for Stethophone in the App Store

Feedback from the field

What’s did you find most valuable about StethophoneTM?

Dr. Satenik Rustamyan – cardiologist and new Stethophone user: I can both hear and see sounds that I would have missed with standard methods. With Stethophone, it’s much easier to catch an extrasystole or determine valve insufficiency in the absence of sounds during traditional auscultation.

The ability to save data is invaluable. A doctor always thinks about their patient, even outside of appointments. And the Stethophone provides the opportunity to reflect further with a solid foundation on objective auscultation data. This is an opportunity that doctors previously didn’t fundamentally have. So, Stethophone is not just a better version of the stethoscope; it’s a conceptually new solution for both doctors and patients.

Another advantage for me, as an educator, is being able to gather several cases from patients with a certain type of cardiac pathology and share and demonstrate them all to medical students. This offers an incomparably deeper understanding of the learning material and a stunning clarity that is unachievable with the classical approach of auscultating and hearing only in real-time.

What about the patient reactions?

Patients get engaged in a way I have never seen before, “So that’s what my arrhythmia sounds like!” I can also find a segments of regular rhythm and visually demonstrate “how it should be.” All of this ensures better patient contact and more successful compliance.

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