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Tag: Regulatory Approval

Biolinq granted de novo classification for needle-free glucose monitor

Biolinq granted de novo classification for needle-free glucose monitor

Heartflow wins FDA 510(k) clearance for next-gen plaque analysis tech

Heartflow wins FDA 510(k) clearance for next-gen plaque analysis tech

Neuromod Devices wins CE mark and other nods for the Lenire device

Neuromod Devices wins CE mark and other nods for the Lenire...

Virtuoso Surgical wins FDA breakthrough device designation for surgical robot

Virtuoso Surgical wins FDA breakthrough device designation for surgical robot

FDA clears Techsomed BioTraceIO360 for kidney ablation

FDA clears Techsomed BioTraceIO360 for kidney ablation

Jupiter Endovascular wins 510(k) FDA clearance for Vertex catheter

Jupiter Endovascular wins 510(k) FDA clearance for Vertex catheter

Amber Implants wins FDA clearance for VCFix spinal system

Amber Implants wins FDA clearance for VCFix spinal system

Novocuff announces FDA IDE approval for a study of its Cervical Control System

Novocuff announces FDA IDE approval for a study of its Cervical...

FDA grants approval for Womed Leaf for women with Asherman Syndrome

FDA grants approval for Womed Leaf for women with Asherman Syndrome

Novocure earns Japanese approval for Optune Lua wearable device

Novocure earns Japanese approval for Optune Lua wearable device

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