Regulatory Approvals

4DMedical receives CE Mark for CT:VQ, enabling EU launch

4DMedical Limited, the global leader in cardiothoracic imaging software, announces that its latest imaging technology, CT:VQ™ has received CE Mark certification for commercial use...

Pixee Medical announces CE Mark for Knee+ NexSight

Pixee Medical, a pioneer in Augmented Reality (AR) guidance for orthopedic surgery, announced it has received CE mark for Knee+ NexSight, its new AR-based...

Meril secures CE mark for MISSO Surgical Robot

Meril Life Sciences has secured CE marking for its MISSO robotic surgical system, a regulatory milestone bringing the platform into compliance with the stringent...

FDA clears Varian’s TrueBeam systems for low-dose radiation therapy

Varian has received US Food and Drug Administration (FDA) clearance for its TrueBeam radiotherapy systems to use low-dose radiation therapy (LDRT) in adults with...

JenaValve wins FDA nod for Trilogy heart valve system

JenaValve announced that it received FDA premarket approval (PMA) for its Trilogy THV system. Trilogy, a transcatheter heart valve (THV) system, won approval for the...

Nia Therapeutics wins FDA breakthrough nod for neuromod

Nia Therapeutics announced that it received FDA breakthrough device designation for its Smart Neurostimulation System (SNS). The device won the breakthrough nod for the treatment...

Perfuze wins FDA clearance for standalone aspiration catheter

Perfuze announced that it received FDA 510(k) clearance for its Millipede88 aspiration catheter. Galway, Ireland-based Perfuze designed the catheter for rapid and complete clot removal...

Endo Tools Therapeutics receives FDA 510(k) clearance for EZFuse

Endo Tools Therapeutics (ETT), developers of advanced endoscopic medical devices, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for...

Prodeon gets FDA clearance for BPH-treating nitinol implant

Prodeon Medical announced that it received FDA 510(k) clearance for its Urocross expander system. Sunnyvale, California-based Prodeon designed Urocross as a novel, non-permanent implant technology...
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