The TGA Approves Medical Wearables
A medical device is any product used to achieve its intended purpose by a physical, mechanical or chemical action. The TGA regulates therapeutic goods including software as a medical device (SaMD).
SaMD has been the source of excitement in Australia since the Series 4 Apple Watch’s ECG feature was approved as a Class lla medical device. It can help detect atrial fibrillation (AF) which can lead to heart failure.
How Does the Medical Technology Hold Up in the Real World?
While no device is perfect, and the TGA understands that, Australia’s medical device requirements are among the most stringent in the world. They include rigorous approval assessments that focus on ensuring devices are safe and perform as intended, and ongoing monitoring of the devices to ensure they continue to meet these requirements.
Samsung is introducing its first smartwatch series in Australia that offer both TGA-approved blood pressure and ECG monitoring. The app is also able to track other health metrics, including body fat percentage (BMI), skeletal muscle weight, and activity levels.
CardiacSense’s patented technology enables medical-grade heart rate and rhythm monitoring, including detection of atrial fibrillation, by continuous photoplethysmography (PPG) and spot electrocardiogram (ECG) with the highest level of accuracy for a non-invasive wearable. It’s a game changer for people with Atrial Fibrillation and their Electrophysiologists as it enables them to monitor themselves over time, without the need for invasive cardiac monitoring. In addition, this medical wearable is the only one of its kind that is TGA approved for a personalised treatment program.
Does the TGA Approve Smart Watches as Medical Devices?
The Australian government body responsible for approving medical devices is called the TGA. The TGA is like the QA team for health tech, making sure that a gadget does what it’s supposed to do and that there aren’t any hidden risks.
All medical devices require TGA approval and inclusion in the ARTG before they can be sold in Australia. The TGA has some of the strictest approval requirements in the world.
Software based medical devices are regulated in Australia as medical device software (unless it’s ‘excluded’ or ‘exempt’). This includes most of the software operating in consumer wearables with health and fitness functions. This is also true of many clinical decision support systems (CDSS) that are embedded in medical devices such as pacemakers.
Does the TGA Approve Smart Watches with ECG Features?
While some smartwatches can record and analyse your heart rhythm, they don’t have the necessary clinical approval for atrial fibrillation detection. The reason is that identifying atrial fibrillation requires sophisticated algorithms and testing on a large number of patients.
Apple launched the Series 4 of their watch with an ECG feature in the US two years ago, but that functionality isn’t available in Australia. However, Withings has now managed to get their latest device approved with the TGA, and it’s now available in Australia.
The Galaxy Watch series is another TGA-approved smartwatch with both blood pressure and ECG tracking. These devices go through rigorous testing and a conformity assessment to confirm they meet the Essential Principles. However, the Samsung device also relies on a single-lead ECG that can be prone to interference and artefact that can affect the accuracy of the result. That’s not as accurate as a 12-lead ECG that can be analysed by a cardiologist to detect AFib.
Does the TGA Approve Smart Watches with Blood Pressure Features?
The latest smartwatches offer a wide range of features for tracking health and fitness. Many feature sleep measurement, heart rate monitoring, and medication adherence tracking to help improve adherence.
Some smartwatches also have ECG (electrocardiogram) capabilities. Apple’s Series 4 was the first direct-to-consumer smart watch to include this feature and it was successfully approved as a Class IIa medical device in May 2021.
The Australian Therapeutic Goods Administration in short TGA follows a rigorous approval procedure to approve medical devices. Its registration procedure takes into account European Union directives. This makes it easier to register low-risk medical devices that have already been CE marked by a Notified Body, such as TUV SUD, in the EU.
OnePhenix is the only IPAAS software that connects your wearable data to your healthcare professionals. www.Onephenix.com.au
References
https://www.gizmodo.com.au/2022/02/smartwatch-medical-technology-features/amp/