It is known that digital disruption is now a commonplace; it’s surely outstanding that it could change the functionality of an ordinary object such as a watch.
And this is already happening in the Apple world; the new-arrived iWatch (series 4) will be able to monitor heart rates, from the wrist of users, making an ECG similar to a single-lead electrocardiogram.
The FDA has issued the medical device authorization for the new Apple Watch, shortly before the launch at the Apple Event this past September.
We are witnessing a turning point: this will no longer represent just a smart watch but it would be a real medical device and for this reason it will have to meet necessary requirements such as scientific evidence, accuracy, security and quality.
In a historical field ruled by solely economics, clinical studies will break out; this is why FDA has given its authorization: the reliability of the heart rate monitor for identifying cases of atrial fibrillation has been valued during the Apple Heart Study, conducted in collaboration with Stanford University and the American Heart Association (419,093 people have enrolled in the study and results are expected next year).
This is the paradigm that FDA wants to pursuit in order to put the patient’s safety at the center of the technologic-innovation-process. On September 26th, it announced the names of the companies that will participate in a program that will review and certify each participant’s process. The Precertification program aims at accelerating the process of obtaining the authorization in the next future.
Furthermore the latest news form this changing regulatory environment is a document issued on October 30th that clarifies which products are considered as “de novo” or unprecedented.
To date the software is not yet available but it will soon be in the USA. And what about Europe?
There is still a long way to go: Apple has to undertake specific procedures to disrupt the European Healthcare System too.