MedTech Spectrum

Article Name Predictive Diagnostics

Exact Sciences Announces License with Freenome for Blood-Based Colorectal Cancer Screening Tests

Freenome submitted the final module of the premarket approval application to the FDA for the first version test

07th August, 2025

Bracco Imaging’s SonoVue® Secures NMPA Approval for HyCoSy Use in China, Enhancing Non-Invasive Infertility Diagnostics

Regulatory milestone supports China’s reproductive health goals by enabling radiation-free, high-accuracy ultrasound imaging to assess fallopian tube patency and uterine abnormalities in women.

06th August, 2025

Body Vision Medical Secures HSA Approval for AI-Powered LungVision Platform in Singapore

Regulatory green light marks full commercial launch of LungVision, enhancing early lung cancer detection through AI-driven 3D imaging for more precise bronchoscopic diagnostics.

06th August, 2025

Roche’s Elecsys® pTau181 Test Signals Paradigm Shift in Early Alzheimer’s Diagnosis

Dr Ashton Harper, Global Medical Affairs Lead for Neurosciences at Roche Diagnostics, discusses how the CE-marked blood test enhances early detection, reduces invasive diagnostics, and aligns with the advent of disease-modifying therapies.

06th August, 2025

Roche’s cobas® Respiratory 4-flex wins FDA nod for customisable, multi-virus PCR testing.

Designed for use with cobas® 5800, 6800, and 8800 systems, the cobas Respiratory 4-flex assay simultaneously detects and differentiates SARS-CoV-2, influenza A/B, and RSV, leveraging TAGS technology and digital reflex capabilities to enhance diagnostic precision and efficiency.

05th August, 2025

Medtronic Targets Renal and Hepatic Arteries in Groundbreaking SPYRAL GEMINI Pilot Study

Sandeep Brar, Vice President of Clinical and Regulatory at Medtronic, shares insights on the scientific rationale, catheter design, and the future of multi-organ denervation in managing hypertension.

04th August, 2025

Advanced MedTech Drives Patient-Centred Innovation in Urology Across Asia

In conversation with MedTech Spectrum, Mr. Wong Yau Chung, Group CEO of Advanced MedTech Holdings, shares how the company is advancing kidney stone care, laser technologies, and digital platforms to address emerging urological challenges.

04th August, 2025

Sony Expands Surgical Display Portfolio with Launch of 43” 4K Mini LED Monitor for Advanced Operating Environments

The new LMD-43M1MD delivers immersive, high-resolution visualisation with wide-angle team visibility and multi-source flexibility, designed to meet the evolving demands of hybrid ORs, complex procedures, and surgical training.

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

MAGENTIQ EYE Secures Series A Funding to Accelerate Global Expansion of AI-Powered Colonoscopy Platform

Led by aMoon, the round fuels development of advanced GI diagnostics and supports global rollout of MAGENTIQ-COLO™, the FDA- and CE-cleared solution enhancing real-time polyp detection and analysis during colonoscopy procedures.

31st July, 2025

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.

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

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.

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

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

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

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