Medtech innovation

Sway Medical Secures FDA 510(k) Clearance for Concussion Management System Expanding Digital Health in the U.S.

The mobile-based solution enhances concussion assessment and monitoring with real-time, objective data for sports, military, and clinical applications across the United States....

China Approves ZEISS VISUMAX® 800 with SMILE® Pro, Elevating Laser Vision Correction Standards

The next-generation femtosecond laser enhances surgical precision, reduces treatment time, and integrates AI-driven features, reinforcing ZEISS’ leadership in refractive surgery innovation....

Averto Medical’s ColoSeal™ Wins FDA Breakthrough Device Designation for Colorectal Surgery

Minimally invasive ICD system aims to eliminate temporary ostomies, improving recovery and quality of life for patients undergoing colorectal surgery....

ParagonCare Partners with Coreline Soft to Advance AI-Powered Lung Cancer Screening in Australia

Strategic collaboration introduces Coreline Soft’s AI-driven imaging solutions to enhance early lung cancer detection, supporting the National Lung Cancer Screening Program (NLCSP) in Australia....

Medtronic Secures FDA Approval for BrainSense™ Adaptive DBS, Pioneering Largest BCI-Enabled Therapy Launch

New real-time, self-adjusting deep brain stimulation system transforms Parkinson’s care with personalized neuromodulation...

CathVision Secures CE Mark for ECGenius System, Expanding Electrophysiology Solutions Across Europe

With CE Mark approval, CathVision’s AI-powered ECGenius System is set to launch in the European market, enhancing real-time electrogram recording and clinical decision-making for healthcare providers....

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. ...

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...

South Korea’s PranaQ Secures FDA Clearance for AI-Powered Sleep Apnea Wearable, Backed by NAVER D2SF

With FDA 510(k) clearance for TipTraQ, PranaQ is set to transform home-based sleep diagnostics. The AI-driven wearable, supported by NAVER D2SF, delivers clinical-grade sleep and respiratory insights, ensuring accessible, multi-night testing and seamless remote monitoring. With FDA 510(k) clearance for TipTraQ, PranaQ is set to transform home-based sleep diagnostics. The AI-driven wearable, supported by NAVER D2SF, delivers clinical-grade sleep and respiratory insights, ensuring a...

CathVision Secures CE Mark for ECGenius System, Expanding Electrophysiology Innovation Across Europe

With CE Mark certification, the AI-powered ECGenius System is now approved for commercialization in the European Economic Area, enhancing real-time electrogram recording and clinical decision-making for healthcare providers....