Medical Diagnostics

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. ...

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....

Cortechs.ai Expands FDA-Cleared NeuroQuant® Brain Tumor with Automated Segmentation of Brain Metastases and Meningiomas

New AI models bring precision and speed to neuro-oncology, enabling fully automated volumetric analysis and seamless integration into radiology, surgery, and radiation oncology workflows—advancing diagnostic confidence and patient care. ...

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....

Alafair Biosciences Earns Dual FDA 510(k) Clearances for VersaCoat™ Flowable Hydrogel

VersaCoat, a syringe-deliverable soft-tissue protector, brings Alafair’s proven hyaluronic acid and alginate formula to complex surgical sites—expanding its impact in orthopedic, trauma, and sports medicine procedures....

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. ...

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 ...

Quasar Medical Establishes Global Headquarters in Singapore to Drive MedTech Innovation and Global Growth

Strategic relocation from Hong Kong strengthens ties to Asia’s thriving MedTech ecosystem, enhances collaboration with global partners, and supports ambitious expansion plans ...

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...

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 ...