FDA Approvals - FDA Issues Approvable Letter For Ceftobiprole For Treatment Of Complicated
FDA Issues Approvable Letter For Ceftobiprole For Treatment Of Complicated Skin Infections (Medical News Today)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), announced that it received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.
AtriCure's Coolrail(TM) Linear Ablation Pen Receives FDA 510(k) Clearance (Medical News Today)
AtriCure, Inc. (Nasdaq: ATRC), a medical device company and leader in cardiac surgical ablation systems, announced that its Coolrail(TM) linear ablation pen received 510(k) clearance from the FDA for the ablation of cardiac tissue. Additionally, the first patient was successfully treated using the AtriCure Coolrail(TM) Linear Ablation Pen.
FDA Clears Expanded Use Of Xoft's Axxent(R) Electronic Brachytherapy System For All Radiation Therapy Indications (Medical News Today)
Xoft, Inc., announced that it has received expanded clearance from the U.S. Food & Drug Administration (FDA) for the Axxent(R) Electronic Brachytherapy System, a proprietary technology platform designed to deliver localized, non-radioactive, isotope-free radiation treatment in minimally-shielded clinical settings.