FDA Issues Non-Approvable Letter for Medtronic’s Amplify (HealthPointCapital)
FDA scotches Medtronic’s Amplify spine device application (Mass Device)
FDA Rejects Amplify (OTW)
The FDA rejects an approval application for Medtronic’s Amplify spinal device over concerns about links between cancer (about 3% more in the treatment patients) and the bone morphogenetic protein used in the device.