Global/International

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 ...

How the FDA’s 510(k) Pathway and Risk-Based Oversight Are Shaping the Future of Medical Device Regulation

By aligning regulatory rigour with technological complexity, the FDA safeguards public health while accelerating access to life-changing medical innovations through adaptive pathways and total lifecycle vigilance...

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 ...

Stryker’s Inari Division Debuts InThrill Thrombectomy System

First and only purpose-built solution delivering rapid and complete luminal clot removal in small vessel and arteriovenous access cases...

Siemens Healthineers Leads the Way in Laboratory Sustainability with ACT Ecolabel Certification for Over 150 Diagnostic Reagents

First in the industry to achieve dual certification for both reagents and analysers within its Atellica portfolio...

Athena Diagnostics Introduces Advanced Genetic Test to Detect Hidden Causes of Ataxia

Developed with PacBio's PureTarget technology, the new test enhances identification of complex DNA repeat expansions to support accurate diagnosis and care for patients with neurological disorders ...

Aptitude Medical Secures $9M BARDA Partnership to Advance Rapid Filovirus Diagnostic for Ebola and Marburg Detection

New Metrix Filovirus Panel to deliver 30-minute, lab-quality results from blood samples in remote and point-of-care settings—marking a pivotal step in global outbreak preparedness. ...

Qynapse Unveils Promising AI-Powered Advances in Alzheimer’s Imaging and Prediction at AAIC 2025

Breakthrough findings for QyScore® and QyPredict® highlight enhanced accuracy in brain segmentation and early identification of cognitive decline, paving the way for improved clinical trials and patient outcomes in Alzheimer’s disease. ...

Stereotaxis Secures FDA Clearance for MAGiC Sweep Catheter

New magnetic ablation catheter designed to enhance precision and reach in robotic electrophysiology procedures across the U.S....

Quanterix Unveils Next-Generation p-Tau 205 and p-Tau 212 Assays to Propel Alzheimer’s Research

Launched at AAIC 2025, the ultra-sensitive assays aim to improve early detection, disease monitoring, and biomarker discovery in neurodegenerative research....