Medical Device
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.
Neptune Medical Secures $97M in Funding, Launches Jupiter Endovascular Subsidiary
Neptune Medical, Jupiter Endovascular, GI robotics, endovascular technology, Series D financing, medical device innovation, healthcare technology
Revolutionary AI and Brain Implants Restore ALS Patient’s Voice
ALS, brain-computer interface, AI, speech restoration, brain implants, medical breakthrough
FDA Approves ARS’s Epinephrine Nasal Spray for Emergency Allergic Reactions
FDA approval, epinephrine nasal spray, ARS Pharmaceuticals, anaphylaxis treatment, needle-free alternative, EpiPen
IDRx Secures $120M for Pivotal KIT Inhibitor Study with Promising Early Data
IDRx, KIT inhibitor, pivotal study, funding, cancer treatment, biotech
Mallinckrodt Sells Immunotherapy Business to CVC Capital for $925 Million
Mallinckrodt, CVC Capital, immunotherapy, Therakos, $925 million deal