Article Name North America
Dräger Atlan A350 Series Earns Highest U.S. Cybersecurity Clearance for Medical Devices
Authority to Operate (ATO) certification from the U.S. Department of Defense affirms Dräger’s leadership in safeguarding patient data, delivering a fully ATO-certified anesthesia portfolio trusted by hospitals worldwide.
12th August, 2025
HistoSonics Announces $2.25B Acquisition by Consortium of Top-Tier Investors
Acquisition will Accelerate Global Expansion of Company’s Breakthrough Edison® Histotripsy Platform and Non-Invasive Tumor Therapy
08th August, 2025
QinFlow Launches Advanced Fluid and Blood Warming Solution to Meet Critical Needs in ORs and ICUs
Founded in 2009, QinFlow is a market leader in fluid thermoregulation solutions.
08th August, 2025
Voxela Officially Launches Next-Generation AI Eldercare Solution “Voxela VCare Pro”
Enhancing eldercare with real-time monitoring, automated reports, and predictive analytics
08th August, 2025
BiVACOR Total Artificial Heart Accepted into FDA’s TAP Program
This milestone further solidifies BiVACOR’s collaboration with the FDA following the TAH’s earlier recognition this year as a Breakthrough Device
07th August, 2025
BD Becomes First MedTech Company to Earn Diamond-Level Resiliency Badge Across All HIRC Supply Chain Domains
BD’s Urology and Critical Care and Surgery units achieve top-tier recognition from the Healthcare Industry Resilience Collaborative, affirming its leadership in supply chain transparency, risk mitigation, and operational excellence
06th August, 2025
Synchron Enables First Thought-Controlled iPad Experience
Synchron Debuts First Thought-Controlled iPad Experience Using Apple’s New BCI Human Interface Device Protocol
05th August, 2025
BMI OrganBank Secures FDA Breakthrough Device Designation for Innovative Kidney Transplant Technology
BMI OrganBank is developing novel medical devices with potential to significantly reduce the waitlist for lifesaving organ transplants, beginning with kidneys
05th August, 2025
BD Invests $35M to Expand U.S. Production of PosiFlush™ Prefilled Syringes
The expansion at its Nebraska facility will boost syringe output by hundreds of millions annually, enhancing supply resilience and supporting safe, high-quality patient care across U.S. hospitals.
05th August, 2025
Concept Medical Launches Major U.S. Trial for Sirolimus-Coated Balloon in Small Vessels
Concept Medical Announces First Patient Enrollment in MAGICAL-SV IDE Trial, Expanding its Coronary Clinical Program Across the U.S. and Europe
05th August, 2025
The FDA Is Phasing Out Animal Testing. Our Replacements Must Catch Up Fast.
In April, Health Secretary Robert F. Kennedy Jr. announced plans to dramatically reduce animal testing at U.S. health agencies. The FDA followed with a commitment to phase out animal studies in areas like monoclonal antibody development, favoring in vitro systems and artificial intelligence instead.
04th August, 2025
BD Submits FDA Application for First At-Home HPV Test with Advanced Self-Collection and Robotic Lab Processing
Designed to detect more high-risk HPV strains than any test on the market, the BD Onclarity™ Assay empowers women with a discreet, non-invasive screening option and leverages full lab automation to ensure accuracy, efficiency, and expanded access to cervical cancer prevention.
04th August, 2025
Demetra Launches Global Spine Division Following Strategic Acquisition of OrthoFundamentals
With the formation of Demetra Spine and recent acquisitions in the US and Europe, Demetra accelerates its mission to revolutionise spinal surgery through infection-reducing, single-use technologies designed for minimally invasive, value-based care.
04th August, 2025
Galaxy Therapeutics Opens New 9,200 Sq. Ft. Facility to Support Global Scale-Up of Brain Aneurysm Solutions
Equipped with ISO Class 7 cleanrooms and expanded R&D capacity, the new site accelerates Galaxy’s path to commercial readiness and global distribution of its breakthrough neurovascular technologies.
31st July, 2025
Gnosis Launches EdenDx™, the First Non-Invasive Liquid Cytology Test for Early Endometrial Cancer Detection in the U.S.
Powered by INEX’s epiHERA™ technology, EdenDx enables accurate, gene-based screening during routine pelvic exams—delivering earlier insights for millions of women at risk, without the need for invasive biopsy procedures.
31st July, 2025
RIVANNA Secures $9.92M BARDA Funding to Fast-Track AI-Powered Fracture Detection System
With total federal support exceeding $52M, RIVANNA accelerates development of CADe/x — an AI-driven diagnostic tool poised to transform musculoskeletal care through automated ultrasound image analysis and real-time fracture triage.
31st July, 2025
ClariMed Achieves ISO 13485:2016 Certification, Strengthening Global Medical Device Development Capabilities
Milestone underscores ClariMed’s commitment to quality excellence and reinforces its position as a trusted partner in navigating complex global regulatory landscapes
30th July, 2025
TrilliumBiO and T-NeuroDx Partner to Advance Blood-Based Diagnostics for Early Alzheimer’s Detection
Strategic collaboration aims to accelerate validation and commercialisation of non-invasive tests, enabling earlier, more accessible diagnosis of Alzheimer’s disease
30th July, 2025
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