Stryker’s Incompass Total Ankle Wins FDA Clearance
Stryker FDA-cleared InCompass Ankle; protein degrader partnerships drive innovation.
Regulatory
Hereditary Angioedema Drug From CSL Gains German Backing
Hereditary angioedema therapy by CSL Behring gains positive nod in Germany.
FDA Import Ban Disrupts Olympus’ US Medical Supply
FDA import ban issued on Olympus medical devices from Japan for quality violations.
FDA Probes Elevidys Deaths, Stirring Regulatory and Market Uncertainty
FDA investigates Elevidys deaths, raising new safety and regulatory questions for gene therapies.
Neuron23’s NEU-411 Trial Shifts the Parkinson’s Paradigm Toward Precision
Neuron23 advances NEU-411 into Phase II Parkinson’s trial, driven by biomarker-based strategies and strong investor support.
Digital Pathology Clearance Accelerates U.S. Market Entry
PathPresenter wins FDA clearance for digital pathology viewer, advancing primary diagnosis and LIS integration.
TISSIUM’s De Novo FDA Authorization Signals Industry Shift
FDA De Novo nod for TISSIUM’s COAPTIUM CONNECT: a new era in sutureless nerve repair.
Arialys Therapeutics Targets First in Class Precision Therapy for Autoimmune Encephalitis
ART5803 targets NMDA receptor autoantibodies, advancing precision therapy for autoimmune encephalitis.
ENHERTU Advances First-Line Endometrial Therapy in Phase 3 Trial
ENHERTU Phase 3 trial launches for first-line endometrial therapy targeting HER2-expressing tumors.
ZEISS CLARUS 700 Gains China NMPA Approval for Retinal Imaging
ZEISS expands retinal diagnostic capabilities in China with CLARUS 700 ultra-widefield imaging system approval.