April 1, 2013 – FDA cleared the NeuroBlate System for use in the U.S. It’s important to note that the NeuroBlate System was never approved by the FDA. Instead, it was merely “cleared” by the 510(k) process, meaning the FDA permitted Monteris to market the device because it was substantially equivalent to a device…
News and Updates
Blizzard Law, PLLC has filed a lawsuit on behalf of a nine year old child who suffered a massive brain bleed after surgeons at Texas Children’s Hospital used a laser probe (“NeuroBlate”) that had been recalled by FDA for causing “unintended overheating” of brain tissue.
The U.S. Food and Drug Administration (FDA) is responsible for policing all prescription and over the counter medications and medical devices. The agency ensures devices and drugs comply with mandated safety standards and ensures manufacturers abide by advertising rules. Unfortunately, the FDA sent far fewer advertising letters out this past year.
There is a fine balance between providing lifesaving medicine to the public and protecting the public from potentially harmful medicine. This is the line the U.S. Food and Drug Administration (FDA) must walk as it regulates drugs and medical devices. However the agency is making tremendous strides in patient safety by allowing more drug inspections in manufacturing facilities overseas.
As patients, we expect the prescriptions our doctors give us to be safe to take. However, a recent study found this might not be the case. Researchers determined one out of every three medications poses additional safety risks after approval from the U.S. Food and Drug Administration (FDA).