What does the FDA's authorization of Apple Watch mean?

Yesterday, Apple announced that the US Food and Drug Administration has approved two new features for the Apple Watch Series 4. One is an advanced method of heart monitoring called electrocardiogram (EKG) and the other is the User Watch ability of an irregular heartbeat. Both features will be available on the device later in 2018 (not at launch). The news seems exciting, but some important precautions limit the usefulness of the new gadget.

First, the FDA's authorization letters for ECG functions and irregular rhythm notification indicate that they are not intended for people under 22 years of age. The irregular rhythm function does not address people who have already been diagnosed who is one of the most common causes of an irregular rhythm. (In other words, this feature is better used by people who are already good.) And the two letters specify that applications "are not intended to replace traditional methods of diagnosis or treatment." They may provide additional information and, but they will not replace a doctor's visit.

Secondly, it is important to understand that the FDA has "erased" both applications, but it is not the same as "approving" them. According to Jon Speer, co-founder of Greenlight Guru, a company that manufactures quality management software for medical device manufacturers, the FDA is usually associated with a new project. The most advanced is the FDA approval, which applies only to Class III products or technologies that may pose a higher risk, but also more advantageous. (Think of implantable pacemakers.) Approval is the gold standard and companies need to do a lot of testing to receive this designation.

The Apple watch is in class II. For Class II and Class I, the FDA does not give its "approval", it simply gives permission. Class I and Class II products are low-risk products – as Speer says, a classic Class I example looks like a tongue depressor – and it's a lot easier to get a license than you'd like. 39; approve.

Most of the time, the products are eliminated because they are sufficiently similar to an existing medical device already regulated by the FDA. Apple pointed out, however, that it had received a "de novo" classification for the EKG function. This means that although it is still in class II in terms of risk and has not been tested as much as an "approved" device, it does not look like anything else on the market. This is the first portable EKG for the consumer. (Last year, the FDA approved AliveCor KardiaBand, a watch accessory that does essentially the same thing, but was not directly aimed at the consumer.)

Historically, saying that something is "de novo" is a less common way of introducing devices to the market, but it is becoming more and more popular, adds Speer, combining fitness gadgets with technology. emerging. "We will continue to see these portable technologies cross and become regulated as medical devices," says Speer. "Think of things that are indicators of your health: blood pressure, heart pressure, respiratory rate, maybe things like diabetes management. The possibilities seem endless.

For example, Omron is working on a blood pressure monitor that looks like a smartwatch. Last year, the European Union announced that the Natural Cycles fertility tracking app could be classified as a medical device. (This may not have been a wise decision, given the controversy around the application.)

"At one point, technology companies were not interested in health care and were not ready to play," said Linda Pissott Reig, Co-Chair of the FDA's FDA Section. 39, lawyers Buchanan, Ingersoll & Rooney. Now we have Apple embracing the field of health care and this high profile announcement, and the FDA is more open to approving these new technologies. Reig points out that the FDA has approved the two new features about a month after the first submission of the application. "The fact that they have had this success quickly with the FDA in response to their request will encourage others to follow their path and be equally encouraged by the fact that these opportunities that the FDA will adopt and bless and allow to continue, " she says.