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The 510(k) submissions process allows the FDA to determine if clinical trials are necessary in the case where a device is nearly similar to one already on the market.
Medical Design Magazine :: MDUFMA II bill includes 510(k) scrutiny
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This is press release from MarketWire about a new patent awarded to ISSYS, Inc.
Integrated Sensing Systems, Inc. - ISSYS Inc. Awarded a Patent for Wireless, Batteryless, Implantable Sensors
I'll try to follow up on the technology behind these systems with someone from ISSYS.
Dr. Nader Najafi, ISSYS CEO, stated that "ISSYS has already established a solid patent portfolio to cover the design and technology of its wireless implant platform. It is exciting to see that the recently awarded patents
are now covering the medical applications of our technology." ISSYS technology supports the trend toward home health monitoring and has the potential to revolutionize the way many diseases are treated. The
particular targets of ISSYS products are cardiovascular disease, especially congestive heart failure, hydrocephalus (high brain pressure), and traumatic brain injuries.
UPDATE: I found the relevant Web page on the ISSYS site, and had a quick phone call with Dr. Cathy Morgan regarding their preclinical studies of the MEMS sensor in monitoring CHF. I will provide more info about the technical detail in a future post.
With all the reports coming out of people figuring out ways to activate their iPhone without subscribing to AT&T, instead using Wi-Fi as the only means of staying connected (but not doing VoIP, alas), there is also the news from T-Mobile which I'm just picking up on now thanks to the Poguester.
T-Mobile's Hotspot @Home allows you to use a Wi-Fi connection to make VoIP calls for just an extra $10/month. That's unlimited calling worldwide, as long as you start the call with the Wi-Fi connection. It will shift automatically to the cellular, if the signal should strengthen. You can use your own router with your DSL service (mandatory), but the one T-Mobile supplies helps save the battery life on the cell phones that support this service.
At the moment, you have a choice of only two phones: the Nokia 6086 and Samsung t409. Both of these are small basic flip phones (both $50 after rebate and with two-year commitment). They sound terrific; over Wi-Fi, in fact, they produce the best-sounding cellphone calls you’ve ever made. But the screens are small and coarse, and the features limited. Fortunately, T-Mobile intends to bring the HotSpot @Home feature to many other phones in the coming months.
It won't work with any network that requires a login, but it works with the T-Mobile Wi-Fi service at Starbucks, Borders, and other shops.
This makes T-Mobile's network coverage competitive with other carriers such as Verizon, and it solves the main consumer complaint of not having a decent signal at home. It also lightens the traffic on the T-Mobile network without them having to make an extra investment in towers and capacity.
To us, a productivity device is anything that helps us Get Things Done while we're out and about, and email, web, and SMS are the holy trinity on a smartphone device. If any part of that trifecta is crap, the whole device may as well be crap. And unfortunately for us, even if you can put up with the keyboard, the Mail client is so awful it actually makes us wish Apple made a Foleo for the iPhone. An iFoleo, if you will. Anyway, if you're anything like us, this is a major, major dealbreaker.
He cites a noticeable delay in opening up even the simplest message, having to delete e-mail messages one by one--then you have to manually delete the items which were sent to trash, no BCC, no integration with OS X's Mail.app, messages on IMAP cannot be marked as read, no ability "mark all / selected" as read, no spellchecking after a message has been saved to draft, and you can only download the latest 200 messages from their server.
He does say that the Yahoo-push IMAP worked "beautifully," but Gmail integration requires POP access.
So as a productivity device, it might be better to look elsewhere or wait for the next version of the iPhone.
I combined all the photographs I took Saturday into one Flickr set.
All were taken with the Nikon Coolpix S10, point & shoot digital camera. Because it has a swivel lens, I could take the photo without much notice since I didn't have to hold the camera up to eye level to view the lcd screen.
Engadget is reporting on this, based on the recent conference call by Ed Colligan, Palm's CEO, that BrightHand noticed.
The comments to this post express the opinion that Palm has fallen too far behind. The availability of software and therefore the flexibility of the Treo still provides an advantage over the iPhone. But I guess, most folks don't care about customization, and the iPhone's UI will it's multi-touch screen makes the smartphone experience really approachable.
Palm needs a Wi-Fi Internet tablet with an 800 x 480 screen. Charge $400, and position it against the iPhone. The lead time would definitely push release of such a product until next year, or maybe later. But now is the time for Palm to reassure its fan base that it can be responsive to changing trends. People are familiar with the Palm OS PIM and calendar, so it has a reputation as a workable system. The touchscreen meme has now been revitalized.
This report also mentions that as of Sunday, 84% of the Apple stores had them in stock.
Ninety-five percent of iPhone buyers in San Francisco, New York and Minneapolis (home to Piper Jaffray's offices) purchased the 8GB model, according to a survey conducted by the firm. About half were new customers for AT&T, at least among the 253 people surveyed for the report.
What would happen if Steve Jobs should introduce a new product based on the iPhone but not a cell phone, more like the Nokia N800 Internet tablet, and sell it for $100 less? Call it the next-gen iPod Web/media player. Perhaps his deal with AT&T forbids this, in which case the other carriers can come up with such a product, capitalizing on the iPhone buzz.
UPDATE: Global Equities Research is estimating that 525,000 iPhones were sold over this past weekend.
Half of the Apple stores on the U.S. West Coast sold out of the devices on the first day, the report said, citing analyst Trip Chowdhry of Global Equities Research in San Francisco.
Wi-Fi gets a boost
When you add a full-featured (relatively speaking) Safari browser and the large touch screen, this device invites Web surfing in a handheld like never before. E-mail is still done more efficiently on the Blackberrys, Treos, etc., but the iPhone has broader consumer acceptance then the type A's who need to be connected all the time. The general public will expect Wi-Fi at a cafe or airport. Or, in any shopping district where leisure time also includes information-seeking needs. This could also boost the notion of advertising specifically who people on the hunt for bargains or highly-rated goods or services.
There will also be a need for stations with Bluetooth keyboards, if you're not carrying one on your own. There'll be those times when you have a need to write voluminously, sometimes prompted by caffeine.
Web tablets/personal media players gain acceptance
This could even have the effect of promoting devices without cellular data but that have Wi-Fi along with a great browser and large screen. This would be something like the Nokia Internet Tablet, 880. You don't need to change your carrier or your plan, and you still have your phone which works well as your phone. It might be better to keep the digital camera in the phone, since it's more easily acceptable.
This is also a boon for companies that produce Web-based applications. Besides shopping and entertainment, you might have a personal health record or another program to help manage a chronic disease such as diabetes or hypertension.
Print media dries up
Print media will no longer be seen as the way to get information to people. Newspapers and magazines are failing, and except for the feature pieces, suffer from lag time. This idea of waiting until the 6 0'clock news to get a rundown on the day is over. In the near future, every citizen will have such a device, subsidized by....? All media will come from these devices. A patient admitted to a hospital won't need to rent a TV, or bring along a laptop, just the charging cord.
Reading a book on a device with a screen like the iPhone is very much unnderrated. Searching, buying, collecting, sharing, annotating, highlighting reading material on a handheld should have progressed at a faster rate that it already has. Finding adequate lighting is no longer a problem, nor is having to purchase large print books or magazines for those with diminished eyesight.
These Web tablets will also be used in schools once the price point can be lowered.
(more later...)
