Headsafe Enters U.S. Healthcare Market with FDA-Cleared Concussion Assessment Device

Headsafe, an emerging Australian medical technology company, today announced its strategic entry into the U.S. healthcare market with the launch of Nurochek™—a lightweight, portable, FDA-cleared brain assessment system engineered to enhance concussion evaluation in clinical settings through proprietary AI and machine learning (ML) technology.

EXALTA Secures EU-MDR Certification for Titanium Compression Screws, Expanding Access to Advanced Trauma Solutions

EXALTA Group, a global leader in the development and manufacturing of integrated OEM solutions for mission-critical medical devices, today announced it has obtained European Medical Device Regulation (EU-MDR) certification for its full range of headed and headless titanium compression screws used in trauma and reconstructive surgery.

2025 US Tariffs in the MedTech Space

Tariff Time Bomb: European and American MedTech Companies Can Act Now to Turn a Potential Crisis into Opportunity

In an era defined by geopolitical maneuvering and protectionist impulses, European MedTech companies now face a pivotal moment. The U.S. administration’s latest proposal to impose steep tariffs on multiple countries worldwide, including European imports, is not just a policy tweak; it is a signal of a return to a high-stakes trade environment reminiscent of history’s […]