The TGA has had discussions with Apple Australia regarding the regulation of software as a medical device according to an email I received from them.
Normally Health Canada pretty much rubber stamps stuff that the FDA or whatever agency is involved in the States does. Not all the time but enough that it's safe to say that, and that's backed up by my wife's experience as a Neo Natal ICU nurse for 31 years. She's seen more cool tech come and go than any of us ever will.Not doubting that, but I think the EU would have been prioritized if it came to launching with the largest customer base with the least regulatory hurdle for Apple.
Thanks for acknowledging that Canada is different than America. We are similar to the US in that we have cars and roads and houses and stuff but we are also so insanely different that you really do have to spend time in both countries to notice how different we are. We get bombarded by American everything in ways that only Mexico would understand and America remembers we're up here when they blame us for the cold weather. That's the relationship, so you are correct that our regulatory process isn't the same as the US and agree that fussing over why certain countries get the ECG feature before others is like trying to figure out why Grandma likes cousin Timmy the best. Life is full of unexplained mysteries. At least we know it's coming now and we'll do what we always do when Apple announces something cool and new.....wait six months while Americans work the bugs out. Let them beta test this one. I'm fine with that.As far as certification in different countries, and how that is obtained, I think it's hubris to assume a bunch of Macrumor postabouts have all the information as to the how, why and when all of that happens. I can see EU being a challenge due to language, or other regulations. Every country is a little different (We will assume EU as a country, given its political structure) Canada, Australia, US. One would assume the US would be first as Apple is a US company. Canada makes sense, about as similar to the US as you can get without being the US. But, vastly different in their approach to health care, and a bi lingual society by law. I'm sure there are regulatory and business restrictions none of us here fully understand. That's lawyer territory.
In the end, if you think it's a dopey toy, don't buy it. It's your money....
The Apple watch won't specifically alert to PVCs, but the ECG will record them and you can show the recording to your doctor.
The TGA has had discussions with Apple Australia regarding the regulation of software as a medical device according to an email I received from them.
Well...so much for ECG functionality at WWCD.
Medical device approval is quite complex, and for good reason as it can affect a human life. It’s not just about money, especially in countries that have their own approval bodies.
Thus there’s a catch 22 for an international company like Apple who tailored their product announcement for US market. This can create an illusion of false advertising simply because many features they announced ended up only being valid for few markets, but the announcement is seen worldwide. Heck, many regions don’t even have the news app.
That’s not up to you to decide, that’s up to the regulators. If you feel you know better, go work for the regulators to change things. If not, your complaints are only a noise.Sorry but a medical device that just potentially detects an issue as a senior is NOT affecting any life in this regard and instance.
That’s not up to you to decide, that’s up to the regulators. If you feel you know better, go work for the regulators to change things. If not, your complaints are only a noise.
Unless you started voting for the politicians that share your views, and/or participate in the lawmaking process itself, your complaints don't really mean anything, tbh. In the end, Apple has to follow the regulations, period.That’s odd, I decided with my dollars and the choice evidently is mine. In context of the ECG feature in the Watch S4, it’s a sensor and it’s not hurting nub s4 user across the globe whom has also chosen with their dolllars. Considering the demand and purchases I’d say this noise you speak of and have responded to, is worth a lot more.
If you really believe regulars are making choices purely and solely for the well being of their citizens, lol, then I could point you to the bank account of Mr Ford (present and past here in Ontario & Toronto respectively; brothers). As of right now it’s all about greasing the right palms with the right amount; else this product would NOT have been made available for sale if there was any REAL concern for the safety of consumers here in Canada.
But your opinion is just as valid as mine. The same regulators were irresponsible in placing fine controls of medical substances allowing them to be easily available for street narcotic consumption, so I wouldn’t believe in their “best interests” as the right way to do things only.