MedTech Spectrum

Article Name North America

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

Johnson & Johnson MedTech Launches VIRTUGUIDE™ System to Transform Bunion Surgery with AI Precision

AI-powered, patient-matched solution aims to simplify Lapidus procedures and enhance surgical outcomes

30th July, 2025

MD Anderson and TOPPAN Forge Alliance to Advance invivoid™ 3D Organoid Technology for Personalized Cancer Therapy

Partnership aims for CAP/CLIA certification of organoid-based assay to guide patient-specific treatment decisions; $10 million investment to fuel clinical validation across multiple cancer types

30th July, 2025

Surgical Safety Technologies Introduces AI-Powered Kinematic Analysis in OR Black Box

First camera-agnostic motion tracking solution for laparoscopic surgery delivers real-time insight into surgical technique and proficiency across all devices and operating rooms

30th July, 2025