FDA Approvals - St. Jude Medical Announces CE Mark Approval And FDA Clearance
St. Jude Medical Announces CE Mark Approval And FDA Clearance For New Family Of HIFU Surgical Ablation Products (Medical News Today)
St. Jude Medical, Inc. (NYSE:STJ) has received European CE Mark approval and U.S. Food and Drug Administration (FDA) clearance for the Epicor(TM) LP Cardiac Ablation System, a second generation technology that uses HIFU (high intensity focused ultrasound) to surgically ablate cardiac tissue to disrupt abnormal electrical impulses in the heart.
FDA Approval, Oversight Of Mifeprex 'Consistent' With Other Drugs, GAO Report Says (Medical News Today)
FDA's approval process and postmarket oversight of Danco Laboratories' medication abortion drug Mifeprex, also known as RU-486, were "consisten[t]" with how the agency handles other drugs with restricted distribution, according to a Government Accountability Office report released Tuesday, Bloomberg reports (Larkin, Bloomberg, 8/18).