Medtronic has been dealt a setback in efforts to win U.S. Food and Drug Administration approval of its Amplify, what it consider a new innovative medical device for the spine. The news came on the same day Medtronic launched its Atlantis Vision Elite Anterior Cervical Plate System in the United States.
The Food & Drug Administration wants more information on possibly elevated cancer risks from Medtronic Inc.’s Amplify spinal implant. The Food & Drug Administration wants more answers about possibly elevated cancer risks from Medtronic Inc.’s (NYSE:MDT) Amplify spinal implant, which uses a bone morphogenic protein to stimulate bone growth. The federal watchdog agency will ask […]
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.