I see it's being prescribed, and to a small-ish number of people (400), so perhaps it's in a trial phase? FDA has 5 phases for medical device development (googled below):

    Step 1: Device Discovery and Concept.
    Step 2: Preclinical Research-Prototype.
    Step 3: Pathway to Approval.
    Step 4: FDA Device Review.
    Step 5: FDA Post-Market Device Safety Monitoring.

They could be on step 3, where they do clinical trials. Maybe working with the VA, or perhaps they advertised at VA hospitals or veteran's groups. I would imagine that's the easiest group to find and recruit into your trial.

I don't think it's restricted to veterans, the website says it's approved for adults 22 or older with a nightmare disorder or nightmares caused by PTSD. You need a prescription, but you don't need to be a veteran.

Yea - could someone shed some light on this? What would the FDA have to do with an app like this? What risk to the public could an app like this pose?

    “We had to get an independent security audit and submit it for FDA clearance”

Security audit is probably a good thing. Maybe they need FDA clearance for doctors to prescribe the usage of an app? That just seems ridiculous to me, but also right up the FDA's alley.

What if it would have worsened it? Or had unwanted side effects? That you call it an "app" doesn't mean it cannot affect your health, to state the obvious. And that's regulated territory, and with good reason.

Why is it ridiculous for a medical device to be reviewed by the governmental agency whose remit includes reviewing medical devices?

Because it's not a medical device, it's a vibrating watch.

This comment is whatever middlebrow dismissal would be, but for basic facts of U.S. law. As per the Food, Drug, and Cosmetics act of 1938, we have 21 U.S. Code §321[1]:

(1) The term “device” (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is

> (A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

> (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

> (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 360j(o) of this title.

The developer of the device themselves clearly understands that this "vibrating watch" qualifies as a medical device.

[1] - https://www.law.cornell.edu/uscode/text/21/321

Veterans have lots of social credit, and this is a marketing piece from Apple.

Much of their target market will feel goodwill toward the Apple brand as a result of Apple developing products that provide help for a group the person so targeted holds in high esteem.

Of course it helps everyone with PTSD, but I assume thay the demographic Apple is targeting with this bit of marketing is more moved by the mention of military veterans than a mention of mental illness in general.

The subheading of the article does say that it is for PTSD without further qualification.