RNS System for idiopathic generalized epilepsy
NeuroPace Inc. received breakthrough device designation status from the U.S. Food and Drug Administration (FDA) for the potential use of its RNS System to treat idiopathic generalized epilepsy (IGE), which constitutes as many as one-third of all epilepsies. The company plans to pursue an indication expansion to include drug-resistant IGE for the RNS System.
The RNS System, a closed-loop technology programmed by physicians, monitors and responds to a patient’s brain patterns and delivers precise therapy in real-time, without chronic stimulation side effects.
NeuroPace CEO Mike Favet says, “The RNS System’s personalized approach to neuromodulation, which recognizes and responds to a patient’s unique brain patterns, may offer a new solution for patients with drug-resistant idiopathic generalized epilepsy, a condition that severely impacts quality of life for the individual and family alike.” https://www.neuropace.com
Reverse shoulder system approved
Catalyst OrthoScience Inc. received clearance from the U.S. Food & Drug Administration (FDA) to market its reverse shoulder system. Catalyst expects to begin a limited user release in the United States in Q2 2021, followed by a commercial launch later in 2021. Reverse shoulder arthroplasty is estimated to encompass more than 60% of the shoulder arthroplasty market.
The single-tray arthroplasty system combines evidence-based attributes of reverse shoulder arthroplasty design. The system offers surgeon-targeted implant positioning and bone-sparing implants. https://www.catalystortho.com