Federal Register: Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development To Support Labeling ClaimsDecember 29, 2009 8:54 am | by FDA (The Center for Devices and Radiological Health) | News | Comments
This document describes how FDA reviews and evaluates patient-reported outcome (PRO) instruments used to measure treatment benefit in medical product clinical trials.
Federal Register: Meeting: Incorporation of New Science Into Regulatory Decisionmaking Within the Center for Devices and Radiological HealthDecember 29, 2009 8:53 am | by FDA (The Center for Devices and Radiological Health) | News | Comments
The purpose of the public meeting is to identify strategies and means for incorporating new science into the regulatory decisionmaking process within the agency's Center for Devices and Radiological Health (CDRH).
[UPDATED 12/23/2009] Recall classified as Class I. Nationwide recall due to stretching or fracture of the sheath during use.
FDA recommends blankets and other products not be used in magnetic resonance [MR] conditional or MR compatible environments
Recall expanded from November recall of 5 lots due to reports of moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. Posted 12/28/2009
Tadiran, a leading manufacturer of lithium batteries, has developed long life 3.6 V lithium thionyl chloride cells capable of delivering continuous around-the-clock power for 20+ years in temperatures as low as -80ºC.
Intersil’s ISL28117 and ISL28217 bipolar low-power precision operational amplifiers combine low noise and low power coupled with low offset voltage, low bias current drift and minimal offset drift over temperature. The products are appropriate for applications that require
XP Power announced a 250W AC/DC power supply, the CCM250, that achieves up to 95 percent efficiency in medical, IT and industrial systems. The high efficiency means that it is said to reduce or eliminate the requirement for heat sinks, or fans for forced-air cooling.
For a month, Pierpaolo Petruzziello's amputated arm was connected to a robotic limb, allowing him to feel sensations and control the arm with his thoughts. Rossella Lorenzi talks to him about the bionic experiment.
AlazarTech announced the release of ATS9350, a 12-bit, 500 MS/s, dual channel waveform digitizer based on the eight-lane PCI Express bus. The RoHS compliant instrument features a dual-port on-board acquisition memory buffer, which enables very fast, sustained data throughput to computer memory.
One lot recalled because labeling on the foil blister card of certain packages were printed with the label reversed, and consumers may not be aware of the warnings of an antihistamine that could cause drowsiness.
GlobTek’s GT-91114 Series of PCB Mount power supplies have double-enforced insulation mechanical configurations, regulated outputs voltage from: 5 V to 48 V DC in 0.1 V increments, up to 6 W of continuous output power. Style enclosed power supplies are potted in a 55.4 mm x 52.0 mm x 23.5 mm impact resistant polycarbonate case with thermal conduction cooling. This family features
Cases of drug-induced hepatotoxicity reported, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure.
Unapproved device with potential for improper sterilization and disinfection.
Increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products during pregnancy.
Potential association between Lexiva and myocardial infarction in HIV infected adults.
Risk of sudden death and cardiac dysrhythmias in patients being treated with Norpramin.
The beating of the heart is often recorded via sound or simply with touch - but there's also another interesting and somewhat lesser known option - light. An infrared emitter/detector pair can be used along with a programmable microcontroller, to effectively visualize the effects of the human body's hardest-working muscle
Silios Technologies announced new mini-colorimeters are based on SILIOS' DVF (discrete variable filter) technology for any application of analysis and control of online products using the visible spectrum. They are composed of a DVF mounted on a CMOS bar plus an electronic board for the control command and the recovery of data via a USB link. The integration
A potential for the navigation PC SPC-1 component to stop working which could result in potential harms associated with this failure.
FDA is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo.
Product found containing the bacteria B. cepacia.
Cardiac Science Corp. Powerheart and CardioVive Automated External Defibrillators: Initial CommunicationNovember 19, 2009 3:50 pm | by FDA MedWatch | News | Comments
Defective components may cause affected devices to not deliver electric shocks, and the device's self-test may not detect the defect in advance of use.
Life Improving Miniaturized Electronics.