University of Milan

The FDA has granted breakthrough device designation to the SonoClear System, an acoustic coupling fluid designed to improve ultrasound clarity during brain tumor resection surgery.

Phase 2 clinical trial demonstrates IFB-088 (icerguastat) meets primary safety endpoint and shows significant reduction in disease progression for bulbar-onset ALS patients.

• Newronika has received FDA Investigational Device Exemption (IDE) approval to commence a pivotal trial evaluating their adaptive deep brain stimulation system for movement disorders, particularly Parkinson's disease. • The company's innovative AlphaDBS system utilizes real-time brain signal feedback to deliver personalized stimulation therapy, potentially offering improved outcomes over conventional DBS treatments. • The upcoming multinational pivotal trial will compare the adaptive system's performance against traditional DBS in advanced Parkinson's disease patients, marking a crucial step toward U.S. regulatory approval.