What the Apple Series 4 ECG does not offer that the HealthWatch Garment does?
Recently, we have been inundated with real and fake news with regards the Apple Series 4 ECG Watch. While Apple has contested that it is a great leap forward in homecare, the medical profession has looked at it as “nothing special”. Rather, they are worried that it will bring chaos to the hospitals with a massive number of false-positives, jamming emergency room availability, preventing doctors from attending really sick patients. While Apple did claim that the FDA granted Apple a “de novo” request for classification, they never explained to the public what that means. Does that mean that the Apple ECG is FDA granted? Not really. All Apple received was a pre-clearance, rather than a full approval with the device being classified as an “over the counter” Class 2 device, the same as a pair of crutches, powered wheelchairs and some pregnancy test kits.
The difference between a “real” medical device ECG and the Series 4 ECG is stark and I decided to compare it to the unique Master Caution® garment manufactured by HealthWatch Technologies (healthwatchtech.com). In short, the Master Caution® is a 12-lead FDA approved hospital grade wearable ECG, that is washable and can be worn comfortably for as long as you so desire (more information can be received from its website – healthwatchtech.com). For this discussion, we want to compare the main subtle features between the 2 options and how they affect me as a patient.
- While the Series 4 is all about monitoring Afib patients over the age of 22, the Master Caution® is not about screening at all but rather is about saving lives for those with or with potential of heart issues or ischemia.
- According to physicians and many columnists, screenings using the Series 4 result in many false-positives as a result of having only 1 lead, leading to diagnosis of diseases that don’t actually exist. This will lead to an overburden on the health system in terms of money and healthcare providers’ time – eventually affecting the patient’s quality of life. As the Master Caution® is a 12-lead FDA approved hospital grade ECG, it has been rigorously tested in real field conditions thus false-positives are not an issue.
- The Series 4 false-positives will cause anxiety and panic for those wrongly diagnosed while those using the Master Caution’s® accurate, hospital-standard ECG remote and continuous monitoring system, will remain calm and collected.
- It seems that those who are interested in using the Series 4 are willing to settle for an FDA-cleared device, and not an FDA-approved medical wearable device, as the Master Caution® is.
- There’s a good reason physicians recommend involvement of experienced professional in ECG procedures. You, as a patient, can decide whether to count on an ECG watch, like the Series 4 or use a wearable medical device coupled with personalized physician supervision, like the Master Caution®.
- The Series 4 ECG watches are a nice thing to have, but are you, as a patient, looking for an add-on or for an integrated medical device?
- An important question for the physician is: Would they accept a patient’s ECG report from an app or from a hospital grade ECG similar to the Master Caution®?
Finally, honestly, I can agree that an ECG app is a nice thing to have but when a medical or clinical decision is required, I choose, any day, a medical hospital-standard device, like the Master Caution®.
