An article on the Australian website IT News provides a great blow-by-blow description of the problems faced by members of the Western Australian Parliament in lobbying their IT department to get iPads added as an approved device under their laptop allowance.
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On June 6, the U.S. Food and Drug Administration approved a device that obviated the need for that second operation, replacing it with a bone-growing drug.
The U.S. Food and Drug Administration has approved a device that combines a small video camera and a computer on a pair of eyeglasses and an artificial retina that is implanted inside the eye.
You buy the right to display a grouping of words in front of your eyes for your private use with the aid of an electronic display device approved by Amazon.
At least one device is approved in Europe and several companies are testing devices in the United States.
That restriction requires that all code run on a device is approved with an unforgeable signature from Apple.
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When the MyDitto beeps twice, the USB drive is ready to be inserted into a Mac or PC, where the MyDitto app on it provides a simple two-list view for dragging files to and from your approved space on the device.
The device was just approved by the FDA for sale stateside after surmounting the same hurdle in Europe almost two years ago -- though it was first launched long, long before that.
But the new law included a loophole called 510(k) that remains today: A device can be approved with few or no clinical trials if it is deemed "substantially equivalent" to a gadget that existed before 1976.
The new KTS TV bands device is designed and approved for fixed operations that serve any broadband data applications.
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The device is still not approved by the Food and Drug Administration in the US, and these trials, and others, are expected to last at least two or three years.
The iPhone OS, by comparison, is a closed operating system where only certain Apple approved products can be loaded onto the device.
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Proponents say recent technology advances enable a more precise administration of the treatment compared to the first device marketed, which was approved by the Food and Drug Administration in 2002.
The FDA will also require sites that implant the device to undergo training with an approved program.
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Based on those results, the agency approved the Argus II as a humanitarian use device, meaning that it may help fewer than 4, 000 people but that these patients have no other alternatives to treat their condition.
Called the Enterra, it was approved in 2000 under the FDA's humanitarian device exemption, which is for devices that target a very narrow group of patients.
The artificial retina, called the Argus II Retinal Prosthesis System, is the first implantable device to treat the condition and is approved for people over age 25 with advanced RP who can see some light.
The magnets they wanted to place inside Patrick weren't approved by the Food and Drug Administration as a medical device, and Scaife knew of no one who had performed the procedure.
Cyberonics' poker-chip-size device, surgically implanted in the chest, is approved for treating drug-resistant epilepsy and has moved into final-stage human tests for the far bigger market of drug-resistant depression.
The FDA approved the Argus II Retinal Prosthesis System as a humanitarian use device, an approval pathway limited to those devices that treat or diagnose fewer than 4, 000 people in the United States each year.
Last month, the FDA approved a new "form-stable" implant from drug and device maker Allergan Inc.
Sprint looks forward to welcoming this exciting, new device into our portfolio as soon as it has been approved through our customary testing process.
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While the FDA can warn against the unsafe use of a medical device, doctors are not prohibited from using cleared or approved devices for an unapproved use within their practice of medicine.
AEDs are approved by the Food and Drug Administration and available as an over-the-counter device for home use.
Device-makers are having a terrible time getting new products that might give them pricing power approved by the FDA. Health reform adds a new 2.3% excise tax on many of the companies (though not lab equipment).
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