Federal Register: Agency Information Collection Activities; Submission for OMB Review; Comment Request; Guidance for Humanitarian Device Exemption Holders, Institutional Revie...February 18, 2010 9:41 am | by FDA (The Center for Devices and Radiological Health) | News | Comments
The FDA is announcing that a proposed collection of information has been submitted to the OMB for review and clearance under the Paperwork Reduction Act of 1995.
Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of MeetingFebruary 18, 2010 9:41 am | by FDA (The Center for Devices and Radiological Health) | News | Comments
On March 18, 2010, the committee will discuss, make recommendations, and vote on the premarket approval application (PMA) for the Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) sponsored by Boston Scientific.
FDA requires REMS that ensures that only those hospitals and healthcare professionals who have enrolled and completed training in risk management program will prescribe and dispense ESAs to patients with cancer.
Consumers who have a history of gastrointestinal ulcers or a bleeding disorder should not use Maalox Total Relief because it contains bismuth subsalicylate, a substance chemically related to aspirin.
Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.
Security experts have found a network of 74,000 virus-infected computers that stole information from inside corporations and government agencies. The find reflects the dangers of having computers with sensitive data connected to the open Internet.More than 2,400 organizations, including...
Voxware Inc., which makes voice-driven software for use in warehouse operations, said Friday that its fiscal second-quarter loss narrowed as costs fell.For the quarter ended Dec. 31, Voxware reported a loss of $528,000, or 7 cents per share, compared with a loss of $1.7 million, or 26 cents per...
With New Mexico cutting schools and health care services, lawmakers fumed Friday over a proposal to finance economic development projects benefiting corporations like the Hewlett-Packard Co.A proposal to allocate $38 million for capital improvements passed the Senate but not before several...
As it introduced a new social hub, Google quickly learned that people's most frequent e-mail contacts are not necessarily their best friends.Rather, they could be business associates, or even lovers, and the groups don't necessarily mix well. It's one reason many people keep those worlds...
Rovi Corp. on Friday reported a profit in the fourth quarter as the company benefited from an increase in revenue and the absence of a loss from discontinued operations in the same quarter a year ago.Rovi, which provides TV listings data and related services, said Thursday that it earned $2.6...
The Chip de BOI (literally, "the Ox chip") is an excellent startup product for the nascent south-of-the border firm CEITEC. The facility, located in Porto Alegre , is the first of its kind south of the Rio Grande.
Should the government be able to track your movements based on cell-phone records, without evidence of criminal wrongdoing? A legal showdown on the closely watched issue unfolded Friday in a federal appeals court in Philadelphia, as the Justice Department battled electronic-privacy groups.
Microsoft Corp. is expected to announce a major revamp of its phone software Monday, in an attempt to regain momentum in a crucial market where it's been overshadowed. CEO Steve Ballmer will be speaking at Mobile World Congress in Barcelona, Spain, the world's largest cell phone trade show, and analysts expect him to reveal Windows Mobile 7.
Satellite TV provider DirecTV Inc. is suing its rival, Dish Network Corp., for running an advertisement claiming that Dish delivers the same programs for less money. The TV commercial shows three TV sets broadcasting the same programs, with Dish costing $39.99 a month, DirecTV costing $63.99 and cable TV at $63.83.
Connor-Winfield’s D32G Series of 3.2 mm x 2.5 mm SMT temperature compensated crystal oscillators (TCXOs) use analog temperature compensation to hold