FDA Hopes to Improve Medical Device Approval Process Via Partnership
The Food and Drug Administration plays a vital role in ensuring the safety of consumers all across the country. It’s the agency’s responsibility to approve only those medical devices that would provide ample benefits whilst mitigating unnecessary risks, and they also keep track of food that might be contaminated in order to prevent an outbreak… read more
Liberation Therapy MS Treatment Criticized by FDA
A treatment that some claim can help combat multiple sclerosis is taking fire from the Food and Drug Administration because they say a correlation cannot be established that would prove the treatment’s efficacy. Under scrutiny is a form of treatment known as liberation therapy. This type of treatment involves using stents or balloon angioplasty devices… read more
SOUND to Prevent Medical Devices Based Off Recalled Designs
An act being considered by the Senate and the House of Representatives takes aim at medical devices whose design was based off of previously recalled products. The Safety of Untested and New Devices Act, known as SOUND, was brought about largely because of complications with a transvaginal mesh implant that had numerous complications. The issue… read more
Bill Aims to Give FDA More Power to Police Medical Products
The Food and Drug Administration’s ability to police new medical products might be strengthened if Democrats get their way. They are in the process of trying to pass a bill that would disallow companies from manufacturing products that are substantially similar from previous items that were recalled or if they are in the process of… read more
Children Mechanical Cardiac Assist Device Approved By FDA
According to news sources, the Food and Drug Administration has recently approved a medical device to help children suffering from heart failure that will reportedly to stay alive while a heart transplant donor can be found. The device us called EXCOR Pediatric System and was developed by Berlin Heart for the purpose of fitting the… read more