Medical Device
Abbott and Dexcom Reach 10-Year Settlement Over Diabetes Sensor Patent Disputes
Abbott, Dexcom, diabetes sensor, patent litigation, settlement, 10-year truce, continuous glucose monitoring (CGM)
Gilead Sciences Appoints Dietmar Berger as Chief Medical Officer to Spearhead R&D Revamp
Gilead Sciences, Dietmar Berger, Chief Medical Officer, R&D Reset, Biotechnology, Pharmaceutical Industry
Embecta Discontinues Insulin Patch Pump Program Amid Restructuring Efforts
Embecta, insulin patch pump, discontinuation, restructuring, layoffs, diabetes technology
Roche Advances Alzheimer’s Disease Diagnosis with Breakthrough Blood Test
Alzheimer’s disease, blood test, Roche, Eli Lilly, FDA breakthrough device designation, pTau217, amyloid pathology, early diagnosis.
Merck & Co. and Mestag Therapeutics Collaborate on $1.9 Billion Fibroblast Therapy Deal for Inflammatory Diseases
Merck & Co., Mestag Therapeutics, Fibroblast therapies, Inflammatory diseases, $1.9 billion deal, RAFT platform, Drug target identification
FDA Approves Over-the-Counter Hearing Aid Software for Apple AirPods Pro
FDA approval, over-the-counter hearing aids, Apple AirPods Pro, hearing aid software, mild to moderate hearing loss
Abbott Launches Lingo, First Over-the-Counter Continuous Glucose Monitor for Health and Wellness in the US
Abbott, Lingo, Over-the-Counter CGM, Health and Wellness, Continuous Glucose Monitoring
FDA Approves Revolutionary Re-Expandable Stent for Young Children
FDA approval, re-expandable stent, young children, congenital heart disease, minimally invasive procedures
Launching a Product in Europe: Understanding Supply Chain Cost Drivers
Supply Chain Cost Analysis, European Market, Cost Drivers, Supply Chain Management, Risk Management
The Post-Chevron Regulatory Landscape: Implications for the FDA and Healthcare Industry
Chevron deference, FDA, regulatory landscape, healthcare industry, Supreme Court ruling, Loper Bright Enterprises v. Raimondo, Corner Post, Inc. v. Board of Governors of the Federal Reserve System, Administrative Procedure Act (APA), judicial scrutiny, legal challenges, regulatory implications.