Clinical & Diagnostic

EMA Approves Takeda’s TAKHZYRO Pre-Filled Pen for Subcutaneous Administration in Adolescent and Adult HAE Patients

The new 2 mL pre-filled pen option expands individualized treatment choices for hereditary angioedema (HAE) patients, reinforcing Takeda’s commitment to reducing disease burden and improving quality of life....

IceCure Medical Seeks Israeli Regulatory Approval for Next-Gen XSense™ Cryoablation System

Building on FDA clearance, IceCure files for Israeli approval of its XSense™ System, expanding minimally invasive cryoablation solutions across multiple medical specialties in line with the growing trend of surgical de-escalation. ...

Co-Diagnostics Withdraws 510(k) Submission for COVID-19 Test to Pursue Enhanced Version

Following constructive discussions with the FDA, Co-Dx shifts focus to an improved test submission, incorporating platform advancements and optimizing long-term performance....

Ginkgo Bioworks Secures €24M EU Grant to Develop Rapid Next-Gen Sequencing for Respiratory Diagnostics

In collaboration with HaDEA and HERA, Ginkgo leads the RANGER project to create a point-of-care metagenomic sequencing device, aiming for 6-hour turnaround diagnostics to revolutionize pandemic preparedness and hospital triage across Europe. ...

UroMems Achieves Major Milestone in First-Ever Smart Implant Study for Female SUI Patientsv

With all female patients in its groundbreaking clinical feasibility study reaching six-month primary endpoints, UroMems' UroActive System marks a transformative step in treating stress urinary incontinence. The AI-powered smart implant, designed to enhance patient quality of life, is now paving the way for expanded adoption in the U.S. and Europe. ...

3Shape Celebrates 25 Years of Innovation with AI-Powered Advancements in Dental CAD Workflows

3Shape is celebrating 25 years of innovation by introducing a paradigm shift in CAD workflows for dental labs with the upcoming release of 3Shape Dental System 2024. This new software update will include a free AI-driven crown design application along with several workflow enhancements to significantly improve efficiency and digitization for dental labs. As the first employee hired at 3Shape 25 years ago, Rune Fisker, Senior Vice President of Product Strategy, reflects on the remarkable evolu...

Encore Clinical Holdings Expands Wound Care Services to Tennessee, Strengthening Leadership in Specialized Care

With its innovative, technology-driven model, Encore Wound Care extends its footprint to Tennessee, enhancing clinical outcomes, optimizing facility operations, and treating over 10,000 wounds per week across its growing service regions....

Zydus Lifesciences & Guardant Health Back India’s First Liquid Biopsy Academy to Advance Precision Oncology

LiS Academy, an independent academic forum led by top oncologists, aims to enhance awareness and adoption of liquid biopsies for personalized cancer care in India....

AESOP Technology Unveils AI-Driven Model to Combat Wrong-Site Surgery and Enhance Patient Safety

Leveraging machine learning, the Association Outlier Pattern (AOP) model provides real-time decision support and retrospective analysis, addressing surgical errors and strengthening healthcare reporting systems....

B. Braun Launches Emergency Department Single-Shot Nerve Block Tray to Enhance Acute Pain Management

Designed for emergency settings, the new tray features the Ultraplex® 360 Needle with advanced echogenic technology, enabling precise regional anesthesia as a safer alternative to opioids. ...