Medical Devices
Page 1 • 12 itemsGain critical insights into global medical device regulatory pathways, market trends, and innovation impacting pharmaceutical R&D and commercialization.
Stryker Australia Receives TGA Approval for Total Temporomandibular Joint Prosthesis
Stryker Australia gains TGA approval for total temporomandibular joint prosthesis, expanding treatment options for TMJ disorders in Australia.
Australia's TGA Section 41HD Emergency Medical Device Import Approvals: Complete Guide for Healthcare Providers
Australia's TGA Section 41HD approvals enable emergency medical device imports during supply shortages. Learn eligibility criteria and application process.
Edwards Lifesciences RESILIA Tissue Shows 10-Year Durability in COMMENCE Aortic Trial Results
Edwards Lifesciences announces 10-year COMMENCE trial data demonstrating long-term durability of RESILIA tissue for aortic valve replacement procedures.
Vector Science & Therapeutics Files Patent for Microneedle Catheter Platform for Cancer Drug Delivery
Vector Science & Therapeutics secures IP protection for novel microneedle catheter technology designed to deliver cancer drugs directly into tumors.
NAMSA and Lexitas Form Strategic Partnership for Comprehensive Ophthalmic Medical Device Development Services
NAMSA partners with Lexitas Pharma Services to offer end-to-end ophthalmic medical device development, creating single-source solution for sponsors.
TGA Issues Guidance on Combination and Boundary Products for Pharmaceutical Companies in APAC
Australia's TGA provides regulatory clarity on combination products like pre-filled syringes and boundary products including nasal decongestants.
Thailand Emerges as ASEAN Medical Device Gateway as Market Set to Reach $18.6B by 2029
Thailand positions itself as Southeast Asia's medical device hub with WHX Bangkok 2026, targeting $18.6B regional MedTech market growing at 7.31% annually.
TGA Updates Comprehensive Regulatory Framework for Implantable Medical Devices in Australia
Australia's TGA provides updated guidance on implantable medical device regulations, covering manufacturing, application processes, and market authorization requirements.
Akso Health Group Launches Brain-Computer Interface R&D Program Targeting Neurotechnology Market
Akso Health Group (NASDAQ: AHG) announces entry into brain-computer interface development, establishing R&D infrastructure for next-generation neurotechnology solutions.
Australia's TGA Updates Personalised Medical Device Regulations: New Guidance for Market Authorization and Supply Chain Compliance
Australia's TGA releases comprehensive regulatory guidance for personalised medical devices, covering application processes, market authorization, and supply chain requirements.
Amcor Opens $35M Healthcare Packaging Facility in Malaysia to Strengthen Southeast Asia Medical Supply Chain
Amcor invests $35M in advanced healthcare packaging facility in Malaysia, bringing sterile medical packaging capabilities to Southeast Asia market.
Sonorous Neurovascular Receives FDA 510(k) Clearance for BosCATH™ Neurovascular Catheter
Sonorous Neurovascular gains FDA 510(k) clearance for BosCATH™ catheter, advancing neurovascular intervention capabilities for complex cerebral procedures.