Regulatory Approvals

OcuSciences has received European Union CE clearance for its OcuMet Beacon, a next-generation diagnostic instrument that aims to advance the assessment of retinal dystrophies...

Zeta Surgical this week announced it received FDA 510(k) clearance for its Zeta TMS Navigation System. The Zeta system is a device that provides real-time,...

Nurea, a pioneer in AI-powered medical imaging, today announced that its PRAEVAorta®2 software has received FDA 510(k) clearance, enabling entry into the U.S. market....

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Surgical Theater’s next-generation platform, SyncAR Spine. The decision enhances the platform’s suite of...

Abbott official posted on social media to announce FDA breakthrough device designation for a new ablation catheter. Abbott SVP Uri Yaron said on LinkedIn that...

Vektor Medical announced it received CE mark approval for its vMap artificial intelligence-powered arrhythmia mapping system. The company’s vMap converts standard 12-lead ECG data into...

AorticLab received FDA approval for an Investigational Device Exemption (IDE) to begin a pivotal clinical trial of its FLOWer System in the U.S. The FLOWer...

Zenflow received FDA 510(k) clearance for its Spring scope and camera control unit (CCU). The South San Francisco, California-based company touts its Spring scope and...

AngioSafe announced it has received FDA 510(k) clearance and CE marking for its Santreva-ATK endovascular revascularization catheter. San Jose, California-based AngioSafe designed the device for...