Regulatory Approvals

Rhythio wins FDA breakthrough nod for injectable electrode tech for defibrillation

Rhythio Medical announced that it received FDA breakthrough device designation for its Injectable Electrode System. The company’s proprietary offering aims to transform cardiac rhythm management....

OcuSciences gains EU CE Clearance for OcuMet Beacon diagnostic device

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 wins FDA 510(k) clearance for TMS navigation system

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 wins FDA clearance for PRAEVAorta® 2 software

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....

FDA grants 510(k) clearance to Surgical Theater’s spine platform

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 gets FDA breakthrough nod for dual-energy ablation catheter

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 wins CE mark for AI-based arrhythmia mapping system

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...

FDA clears pivotal trial for AorticLab’s FLOWer embolic protection system

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 gets FDA nod for single-use cystoscope

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...
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