Viewing profile — seehafer

Sid — I’m at FDA and would like to talk to you about your proposals to make industry more patient friendly. Will reach out to this address unless there’s a better one.

Though (very) unevenly distributed

Yet again we see that Steve Jobs’ user interface instincts were right: he hated the idea of apps and fought putting them on the iPhone.

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 co…

I am a great admirer of Tyler’s but he often does too much thinking and too little feeling, particularly in the context of art.

> 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…

> 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 equ…

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.…

Great to see Dr. Rezai getting his due. One of the pioneers of neuromodulation; he's been involved in deep brain stimulation since the early days.

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 (amo…

Same. I’m fact I suspect a large proportion of HN’s audience started around this age.

This evokes the Internet of the 90's, when it was home mostly to misfits, nerds, and outcasts. A simpler time. A happier time.

We’re talking about California here, which is functionally a single-party state, and that party is not the Republican Party.

The European Commission is likely going to keep extending out their MDR transition timeline indefinitely. That or allow thousands of devices to get taken off the market.

Had a very similar experience hanging out with him and his equally-brilliant wife Robyn in ATX between 2011-2012. Very approachable guy -- impressively so, given his stature in the…

This change would have certainly increased overall risk so a new 510(k) would have been required if this device was already commercialized. And had your management not backed down,…

Fellow Snow Leopard fan here. Best version of any OS, ever, in my estimation.

Carol Leifer was a writer on the show for many years and the inspiration for Elaine, as she was an ex-girlfriend of Jerry’s and they remained friends after the breakup.

> This company is the next Theranos, and I don't think it's even that bold of a statement to say. It’s a very bold statement to say when you have no evidence that Boom would or eve…

Half of the Board of Supervisors at any given time are just as bad as Dean, they’re just less vocal. The actual problem is the SF electorate.

Another iPhone SE fan here. Among all the other benefits listed in this post, there’s also no notch. I hate the notch and I can’t believe Apple industrial design is fine with it be…

Same. Richard, you & your startup were one of the most memorable from our batch. So sorry to hear this news. I suspect there are other founders that feel the way Mike and I do.

The title of this article ought to be: Former nuclear _regulators_: Say ‘no’ to new reactors To which I say: “this is my shocked face”

>These guys are politicians first, scientists second - you don’t ascend to the head of their respective agencies without toeing the line, and being savvy to the political climate. …