Loading...
*  Medical equipment management
Manufacturer: This is the name of the company that received approval from the FDA to sell the device, also known as the ... Newly acquired devices should be inspected by in-house or contracted biomedical equipment technicians (BMETs), who will receive ... Nomenclature: It defines what the device is, how, and the type of maintenance is to be performed. Common nomenclature systems ... This number is crucial to device alerts and recalls. Acquisition cost: The total purchased price for an individual item or ...
*  List of off-label promotion pharmaceutical settlements
... allegations that it marketed and distributed its sinus spacer product for use as a drug delivery device without FDA approval. ... Trisenox won approval by the FDA in 2000 to treat a relatively rare form of leukemia known as acute promyelocytic leukemia, but ... Serono, a Swiss biotechnology company, obtained approval from the FDA for the drug Serostim in 1996 to treat AIDS wasting, a ... The company allegedly promoted LC Bead, its embolization device-designed, to be inserted into blood vessels to block the flow ...
*  Management of depression
Use of such devices in the United States requires approval by the U.S. Food and Drug Administration (FDA) after field trials. ... A variety of medical devices are in use or under consideration for treatment of depression including devices which offer ... 2011 meeting of the Neurological Devices Panel Meeting to Discuss the Classification of Electroconvulsive Therapy Devices (ECT ... "FDA Panel Looks at Trials of Devices to Treat Depression" article by Emily P. Walker, Washington Correspondent, MedPage Today ...
*  Computer access control
Access approval is the function that actually grants or rejects access during operations. During access approval, the system ... Where you are, for example inside or outside a company firewall, or proximity of login location to a personal GPS device. ... A more narrow definition of access control would cover only access approval, whereby the system makes a decision to grant or ... Authentication methods and tokens include passwords, biometric scans, physical keys, electronic keys and devices, hidden paths ...
*  Today sponge
Vorhauer struggled for seven years to get the device approved and on the market. Following FDA approval, the brand was rolled ... Los Angeles Times FDA's approval of the Today contraceptive sponge: hearing before a subcommittee of the Committee on ... Birth control device linked to toxic shock. The Free Lance-Star Rosenthal MS (2003). The Gynecological Sourcebook, p. 144. ... The Today sponge also broke the barrier in several markets for advertising contraceptive devices. The Today sponge "was ...
*  History of the petroleum industry in Canada (oil sands and heavy oil)
The reason for the long gap between approval and completion was an alarming escalation of costs that beset all major North ... The company proposed detonating a 9-kiloton explosive device below the oil sands at a site 100 kilometres south of Fort ... In 1962 (the same year the Great Canadian Oil Sands proposal went up for approval) Cities Service Athabasca Inc. proposed a ... In 1962, Great Canadian Oil Sands Limited (GCOS) received approval from the Alberta government to build and operate a 10,000 ...
*  Destination therapy
... including the next generation of the device, HeartMate II, which is expected receive FDA-approval in early 2010. "Implantation ... Ventricular assist devices require open-heart surgery for implantation. An incision is made through the breastbone to expose ... Based on the results of this study, the U.S. Food and Drug Administration (FDA) granted a Premarket Approval for the Thoratec ... As of September 2009, the Thoratec HeartMate XVE is the only FDA-approved device for use specifically as destination therapy. ...
*  Commendation Medal
The Operational Distinguishing Device ("O" device) is authorized for wear on the Coast Guard Commendation Medal upon approval ... Devices Oak leaf cluster and "V" Device The U.S. Air Force began issuing its own Air Force Commendation Medal in 1958 with ... Devices Oak leaf cluster and "V" Device After the First World War, the Department of the Navy authorized the Navy Commendation ... Devices Oak leaf cluster (for subsequent awards) "V" Device (for valorous actions in direct contact with an enemy) The Army ...
*  Clinical trial
... manufacturers of medical devices in the United States are required to conduct clinical trials for premarket approval. Device ... They are conducted only after they have received health authority/ethics committee approval in the country where approval of ... device A versus device B, or therapy A versus therapy B) While most clinical trials test one alternative to the novel ... if the study involves a marketable drug or device), the regulatory agency for the country where the drug or device will be sold ...
*  Installation (computer programs)
An operating system may automatically install a device driver for a device that the user connects. (See plug and play.) Malware ... such as a similar app approval process, the use of Apple ID for purchases, and automatic installation and updating. Although ... Included in the dock as of 10.6.6, the Mac App Store shares many attributes with the successful App Store for iOS devices, ... Installation (or setup) of a computer program (including device drivers and plugins), is the act of making the program ready ...
*  Robert M. McDowell
This effort resulted in the revolutionary approval of low-power medical wireless devices to operate in specific frequencies, ... Devices used in these frequencies include electronic implants that allow paralyzed patients to regain use of their limbs, as ...
*  Intervertebral disc arthroplasty
This past year The Mobi-c Disc manufactured by LDR was approved in the United States and has FDA approval for one or two level ... The devices and results were not met with acceptance within the spine surgical field though some early surgeons reported good ... The first device approved for use in the United States was the Charite artificial disc. Invented at Charite University Hospital ... While these discs have received FDA approval, some insurance companies in the United States do not cover the surgery, still ...
*  CTX (explosive-detection device)
In the late 1990s, L-3 Communications developed a competing computerized tomography system that also met FAA approval. In ... The CTX (Computer Tomography X-ray) is an explosive detection device, a family of x-ray devices developed by InVision ... to characterize materials in checked bags and automatically identify objects that could be improvised explosive devices. The ...
*  Substantial equivalence
Premarket Approval]. Submitters must compare their device to one or more similar legally marketed devices and make and support ... a new Class II device that is essentially similar to an existing device can be cleared for release without further testing. The ... "A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective ... The term was borrowed from the FDA's 1976 substantial equivalence definition for new medical devices-under Premarket ...
*  Loretta Marron
Her investigations into fraudulent practices led to cancellations of the approvals for nine alternative "medical" devices from ...
*  Celacade
Vasogen in collaboration with Grupo Ferrer Internacional has regulatory approval to market Celacade as a medical device for the ... Celcade is a device-based outpatient procedure involving ex vivo exposure of 10ml autologous blood to heat, ultraviolet ... has recommended that Vasogen conduct a further confirmatory study to support a pre-market approval filing. Visioli F (September ...
*  Scanning Fiber Endoscope (SFE)
Applications for the device (which is pending FDA review and approval), are expected to include medical diagnosis and support ... When these devices are reduced in size, they suffer severe resolution degradation, resulting in an image quality that equates ... The PSF in endoscopes has the greatest impact are the inside the device at the real focal plane. In the FOV application the ... Expected diagnostic applications include plaque luminal characterization for better device selection, endothelization of prior ...
*  Food and Drug Administration Amendments Act of 2007
Title III requires applications for a humanitarian device exemption, an application for premarket approval of a medical device ... It excludes a person granted a humanitarian device exemption from the prohibition against selling the device for an amount that ... the device was not approved for pediatric patients prior to enactment of this Act; (3) the number of devices distributed does ... the review time for each approved device. It authorizes the FDA to determine that adult data on medical devices may be used to ...
*  HTC HD2
Microsoft has expressed tacit and subtle approval of such ports, nearing the release of Mango for native Windows Phone devices ... It is possible for users to call Microsoft to request an activation key, but the device is not supported as a WP7 phone and ... In December 2012, Windows RT and Windows Phone 8 were ported onto the device as a proof-of-concept; no working builds exist. On ... In addition, many customised versions of Windows Mobile are available for the device, with versions 6.1, 6.5, 6.5.3 and 6.5.5 ...
*  Approval
... a voting system Approval proofer, an output device used in Prepress proofing Approved drug, formal government approval of a ... Approval may refer to: Approval rating, a polling term which reflects the approval of a particular person or program Approval ... medication for sale Social approval, the positive appraisal and acceptance of a person by a social group. ...
*  Diversified Products Corp v Tye-Sil Corp
The Court of Appeal cited with approval jurisprudence that stands for the proposition that "an impractical and inoperable ... device cannot be an anticipation". The invention dealt with a conventional rowing machine usable in an upright position. The ...
*  Allergan
300 million plus future sums tied to approval/sales milestones. In November the company acquired aesthetic device company ... In September the company announced it would acquire ophthalmic device start-up AqueSys for $ ...
*  Riegel v. Medtronic, Inc.
... claims that challenge the effectiveness or safety of a medical device marketed in a form that received premarket approval from ... is a United States Supreme Court case in which the Court held that the pre-emption clause of the Medical Device Amendment bars ... The Supreme Court and Medical Device Regulation". New England Journal of Medicine. 357 (17): 1680-1681. doi:10.1056/NEJMp078142 ...
*  Bumper (car)
42: Uniform Provisions Concerning the Approval of Vehicles With Regard to Their Front and Rear Protective Devices (Bumpers, etc ...
*  Traian V. Chiril─â
Initially known as "Chirila keratoprosthesis", this device has been commercially developed as AlphaCor and received approvals ...
*  Central Catholic High School (Bloomington, Illinois)
Mayor Tari Renner refused to sign-off on the approval pending an attorney general opinion on whether any conflict of interest ... A 2013 upgrade installed school-wide wireless internet access in conjunction with a new bring your own device program. A ...
*  Febuxostat
... and Teijin obtained approval from the Japanese Pharmaceuticals and Medical Devices Agency in 2011. Febuxostat is used to treat ... Ipsen obtained marketing approval for febuxostat from the European Medicines Agency in April 2008, Takeda obtained FDA approval ... Ipsen obtained marketing approval for febuxostat from the European Medicines Agency in April 2008, Takeda obtained FDA approval ... February 14, 2009 Press release: ULORIC® (TMX-67, febuxostat) Receives FDA Approval for the Chronic Management of Hyperuricemia ...