One of the promises of wearable tech has been the possibility of making wearers' data available for clinical trials. There are have been about a million obstacles to that goal. A recent two-day seminar at the New York Academy of Sciences discussed this very issue, with opinions ranging from "it's too complex so it'll never happen" to "here's how we're doing it today." But … [Read more...]
Proteus, Otsuka, Submit First Wearable Drug to FDA
Frequent readers will know that Proteus Digital Health has been testing a wearable skin patch that monitors compliance with drug protocols. At last, three years after announcing the alliance, Proteus and its partner Otsuka have submitted for FDA approval an instrumented version of the anti-depressant Abilify. Although Proteus's Digital Health Feedback system had already been … [Read more...]
WSJ: Apple to Make 5 Million Watches, But Not Sure Why
With Mobile World Congress and its attendant blizzard of news about all things mobile coming up in a couple of weeks, Apple is newsbombing the proceedings with leaks about the forthcoming Apple Watch. The Wall Street Journal has carried a couple of interesting pieces in the last day. One article puts the initial production run at 5 million units. The other, more interesting, … [Read more...]
FDA Publishes Health Device Security Guidelines; Public Workshop Set
As wearables move further into the realm of bona fide health devices (see our site Health Tech Insider for lots more on the subject), developers and manufacturers will inevitably have to deal with the U.S. Food and Drug Administration. The FDA regulates health devices. Most current wearables don't fall under its jurisdiction, but it's entirely possible that more sophisticated … [Read more...]
Apple Hires Exec With FDA Approval Background
A couple of months ago, you may remember, Apple apparently sat down with officials of the U.S. Food and Drug Administration to talk about ... well, no one really knows what, but the widespread guess is that it had something to do with the much-rumored iWatch. Now, there's word that Apple has hired Divya Nag, an up-and-comer in the medical device world who has significant … [Read more...]
NYTimes says Apple Execs Met with FDA, Signaling a Heath-Related Device
The New York Times reports Friday evening that a bunch of high-ranking Apple executives met last month with some top folks at the U.S. Food and Drug Administration, the agency that regulates health devices. According to the Times, Apple was represented by Bud Tribble (VP of software), Jeff Williams (SVP Operations), and Michael O'Reilly (former chief medical officer of … [Read more...]
WAPost on Wearables Privacy
We're a little late on this, but our attention was just drawn to a really good Washington Post article about privacy concerns surrounding wearable tech (limited reads). The piece uses recent Samsung launches as the news hook, but it raises good questions about FDA and FTC regulatory issues that device makers and app writers might run up against. The massive amount of data … [Read more...]