Regulatory Approvals

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Terumo Interventional Systems’ (TIS) OPUSWAVE dual sensor imaging system, marking the company’s...

The US Food and Drug Administration (FDA) has cleared NeurAxis’ percutaneous electrical nerve field stimulation (PENFS) system for treating pain linked with a chronic...

Glaukos announced that the FDA approved its Epoxia incision-free alternative to traditional corneal cross-linking procedures. Epoxia offers an advancement in corneal cross-linking for the treatment...

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 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...