1. BioMedical Enterprises has been approved for its Hammerlock Intramedullary Fixation System for hammertoe deformities, which features an upgraded linear body for easier joint fusion, better flexibility for positioning the device and easier insertion.
2. Janssen Therapeutics received approval for OLYSIO (simeprevir), an NS3/4A protease inhibitor that treats chronic Hepatitis C.
3. OrthAlign received 501(k) clearance to market its OrthALIGN Plus system for total hip and total knee arthroplasty surgeries.
4. Neuropace received approval for its RNS Stimulator, an implantable device that decreases the number of seizures for patients with drug-resistant epilepsy.
More Articles on the FDA:
FDA Issues Safety Communication on Certain HeartStart AEDs from Philips Medical Systems
Drug Quality and Security Act Regulates Compounding, Enhances Supply Chain Security
FDA Recalls Spacelabs Healthcare’s Anesthesia Workstations
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