FDA requires risk management plan and class-labeling changes for all LABAs.
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.
STMicroelectronics has introduced an integrated low-noise ultrasound pulse controller. Built using the company’s high-voltage BCD mixed-signal technology, the STHV748 provides four independent channels, each of which generates
E-Switch introduced the LP15 series illuminated pushbutton switch, featuring multiple LED colors, custom marking options for the caps, and several cap sizes. The LED colors available are red, blue, green, yellow, and white. Four different
Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): RecallFebruary 9, 2010 3:51 pm | by FDA MedWatch | News | Comments
Device may not be able to deliver therapy during a cardiac resuscitation attempt.
Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.
At today’s International Solid State Circuit Conference, imec and Holst Centre report an analog-signal processor ASIC (application-specific integrated circuit) – in short ASP - that reduces the overall power consumption of an ambulatory heart activity signal monitoring systems by more than 5 times. This is a major step towards autonomous wireless sensor systems powered, which constantly monitor the patient’s health for diagnosis or chronic illness.
Scientists have found specific genetic variants which may explain why some people age earlier than others and say their findings have important implications for understanding cancer and age-related diseases. Dutch and British researchers analyzed more than 500,000 genetic variations from human gene maps and found that people with particular variants near a gene called TERC were likely to be biologically older by 3 to 4 years.
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket SurveillanceFebruary 8, 2010 9:51 am | by FDA (The Center for Devices and Radiological Health) | News | Comments
The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency.
Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri.
Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas MedicalFebruary 4, 2010 12:51 pm | by FDA MedWatch | News | Comments
Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.
Newly approved ecomagination products help hospitals reduce costs and waste, delivering positive benefits to the environment
Voluson E8, Voluson i and ViewPoint highlight company focus on women’s healthcare
Federal Register: Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public Meeting; Request for CommentsFebruary 3, 2010 11:51 pm | by FDA (The Center for Devices and Radiological Health) | News | Comments
The purpose of the public meeting is to identify actions that CDRH can consider taking to strengthen the premarket notification process for review of medical devices, also known as the 510(k) process. FDA is seeking input on a number of identified...
Federal Register: The Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of MeetingFebruary 3, 2010 11:51 pm | by FDA (The Center for Devices and Radiological Health) | News | Comments
On March 12, 2010, the committee will discuss, make recommendations, and vote on a premarket approval application for the Deep Brain Stimulation System for Epilepsy sponsored by Medtronic, Inc.
Federal Register: Workshop on Pediatric Neurological and Neurocognitive Assessments for Cardiovascular Devices; Public WorkshopFebruary 3, 2010 11:51 pm | by FDA (The Center for Devices and Radiological Health) | News | Comments
The purpose of the public workshop is to solicit information from clinicians, academia, professional societies, other government agencies, and industry on various neurological and neurocognitive assessments for pediatric patients implanted with...
Cal Sensors announced the launch of PIREPlus, a high-output, high-pulse rate emitter that can be pulsed as a source of blackbody radiation for near-to-far infrared applications at 180 Hz with 50 percent modulation depth. With a pulsing speed that is asserted to be 18 times faster than alternative technologies, the emitter
BEAR Power Supplies has introduced its BE Series external AC/DC power adapters. The units are Energy Star qualified and factory-configurable for commercial, industrial and medical instruments. The BE Series includes wall-mount converters from 5 W to 30 W, and desktop converters from 15 W to 60 W. All have
ITT Interconnect Solutions has expanded its family of sealed, miniature, lightweight connectors for modern and "future soldier" applications with a "Super Clean" version. Also suitable for medical use, the Nemesis SC connectors are