Can you imagine a consumer-level product _AND_ an FDA-approved product? That would be a hell of a "new category" to enter! The margins would be fantastic. And the competition would be behind for years (due to the long FDA approval process). This would perfectly fit in with Cook's recent comments.
The 510k Premarket Approval process can typically be completed in less than 180 days and often less than 90 days.
So, at this point the iWatch appears to just be a display device, which frankly doesn't seem like it warrants Apple's time and effort. In short, all we learned is that while Apple is interested in health stuff, the iWatch's role will be secondary and won't require FDA approval, so it won't be a Fit alternative.
I wonder what's going to make the iWatch compelling? I'm more confused than ever.
Please note that the unannounced device is, in fact, most likely a sensor-laden, self-monitoring device. The difference is that the device is not a medical device. The device will be an magnificent evolution of the quantified self. The device will almost certainly include blood glucose monitoring.
I believe that Apple is developing what is essentially a mobile sports performance laboratory. This is, if correct, a revolution in sports performance.
activity tracking
blood glucose
blood oxygen levels
thermoregulation
total energy expenditure
NOTE: The FDA heavily revised their guidance to distinguish between self monitoring blood glucose test systems (SMBGs) and blood glucose monitoring test systems for prescription Point-of- Care use just last month.
Rumors about a future wrist-worn smart device from Apple continue to emerge, with one report Monday claiming the team in Cupertino, Calif., working on the so-called "iWatch" has grown to include more than 200 people.
If it also does golf course GPS on it's own, not relying on my iPhone, I'm in.
If not my next watch will be a Garmin golf course GPS watch this spring.
The iWatch will then have to wait for a few years!
Can't wait. AAPL stock will look cheap at these prices once the world realises the company can still popularise and dominate new product categories. Note they don't have to be able to invent the category, just to take it and make it work at Apple levels of user experience and provide that quality at truly vast production scaling.
Comments
The 510k Premarket Approval process can typically be completed in less than 180 days and often less than 90 days.
Please note that the unannounced device is, in fact, most likely a sensor-laden, self-monitoring device. The difference is that the device is not a medical device. The device will be an magnificent evolution of the quantified self. The device will almost certainly include blood glucose monitoring.
I believe that Apple is developing what is essentially a mobile sports performance laboratory. This is, if correct, a revolution in sports performance.
activity tracking
blood glucose
blood oxygen levels
thermoregulation
total energy expenditure
NOTE: The FDA heavily revised their guidance to distinguish between self monitoring blood glucose test systems (SMBGs) and blood glucose monitoring test systems for prescription Point-of- Care use just last month.
Rumors about a future wrist-worn smart device from Apple continue to emerge, with one report Monday claiming the team in Cupertino, Calif., working on the so-called "iWatch" has grown to include more than 200 people.
If it also does golf course GPS on it's own, not relying on my iPhone, I'm in.
If not my next watch will be a Garmin golf course GPS watch this spring.
The iWatch will then have to wait for a few years!
That's not a shock.
That's not a shock.
Budum tss
I wonder how big this thing will actually be considering all the stuff they're supposedly packing into it
Direct drug injection feature.
Ah, yes...a "sports enhancement" device. Apple will call it the iCan in a nod to one of it's investors.