Counter view: Steve Jobs instincts were about owning everything. Any app should (must) be bought from apple, as a subscription, while holding your data hostage, at their price.
That’s not how the iPhone worked. All the apps were pre-installed when the phone was purchased. There were no additional downloads or subscription (other than phone service).
You're not seriously suggesting the multiple apple subscription services were brought in because 3rd party apps became a thing?
The original iphone had zero market share on release. First one is free. Just like Appletv, applemusic, icloud storage, apple games subs....
If you think apple's approach has ever been anything else but abusing market power to maximise revenue I've got a bridge for you with microsoft written on the side. (MS are all like "We'd have been crucified for that, well not anymore!" And the race to the bottom of your wallet continues apace.)
You said it was Steve Jobs’ instincts. He’s been out of the picture for 13 years, before most, if not all the subscriptions you mentioned. Those were Tim Cook looking to make up for the iPhone reaching market saturation.
I was pointing out that Jobs’ instinct on the iPhone was web apps, because that’s what it launched with. The App Store was a response to customer demand and people hacking stuff onto it anyway. And of course, they looked to make money on it, as they are a business and it requires money to build and maintain the platform.
As far as their approach only ever being abuse of market dominance, that simply doesn’t make sense. In the late 90s and early 2000s they didn’t have much of a market to speak of. There was no market to abuse. Apple has been around for decades with pretty famous ups and downs.
510(k) summaries are always a negotiation between FDA (which wants as much data as possible in them) and manufacturers (which want as little data as possible, as it is priceless competitive intelligence)
> This is the "efficacy" part of "safety and efficacy".
Yes. FDA 100% cares if your device works as well. "Works as well as the predicate" is the foundation of the substantial equivalence paradigm that underlies the 510(k) process.
Better is a different story. Legally, they _can't_ care (in a 510(k) anyway), if it works better or not.
Hi, author here! I think my main concern with this process is that the predicate itself might never have gone through clinical trials.
So even if the new device works as well as the predicate, that predicate might be equivalent to a whole chain of devices that have never gone through clinical trials.
This might be fine if the device is low risk, but the 510(k) process has a history of clearing devices that have resulted in patient deaths.
Of course it's a balance between too much red tape and having unsafe devices, I was just personally surprised at where the FDA draws the line today.
Did you thoroughly read through the linked sources?
Because in source number 5, it mentions that some fraction of Class III submissions are cleared through the 510(k) process and not exclusively through the PMA process.
> In 2007, Congress asked the Government Accountability Office (GAO) to review the 510(k) process. The resulting 2009 GAO report described the 510(k) process as less stringent, faster, and less expensive than the PMA process and concluded that 66% of Class III submissions cleared through the 510(k) process in recent years were “implantable, life sustaining, or of significant risk,”
> Because in source number 5, it mentions that some fraction of Class III submissions are cleared through the 510(k) process and not exclusively through the PMA process.
Yes, these are what are known as "pre-amendment" devices, referring to those types of devices that were legally marketed in the US prior to the 1976 amendment to the FD&C Act that gave FDA power to regulate medical devices. FDA was given power to require these devices require PMAs via rulemaking, and has been slowly (far too slowly, in the views of many) closing this loophole.
I'm pretty sure the GAO report is largely referring to Class III devices approved after 1976 in this section... under less restrictive rules of some kind.
From a submission standpoint, as I write this, FDA seemingly cares more about cybersecurity than your medical device actually demonstrating safety and efficacy within intended use. The time that review teams have to review any given device has stayed the same, but fear-driven, heavy-handed cybersecurity regulations (which must be followed) have been added to the mix.
I’ve seen two papers on stimulation and entrainment of brain waves. Is there any place that has a huge pile of resources on that? Everything from introductory to cutting-edge papers?
"neuromodulation" mostly means deep brain stimulation since it's by far the most effective and clinically - if you pubmed stuff, there's reams of reams of papers (probably written by someone else than Ali Rezai...). That being said, anything re above neurophysiology is mostly still handwaving, bc honestly, we still don't know exactly how it works.
Prop 13 was an effect, not the cause. The cause was and remains a lack of housing supply. Prop 13 was a knee jerk reaction to skyrocketing property values in the 70s caused by (among other things) policy (largely NEPA and CEQA) that was weaponized to make it ever more difficult to build.
Yes, I wouldn't say it's the biggest problem. But it has created a serious block against housing liquidity. Something that protects seniors and those on fixed incomes from losing their homes is good - lots of states have laws like that - but prop 13 is fatally flawed.
Unfortunately California democrats can hardly be considered liberal, much less socialist. The neo-liberal ideology seems to be nearly as corporatist as the most die hard republicans.
