Regulatory Approvals

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

Heartflow received FDA 510(k) clearance for its next-generation Heartflow Plaque Analysis algorithm. With clearance, the Mountain View, California-based company says its algorithm is now available...

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

Neuromod Devices announced it received significant regulatory nods to bring its Lenire device to Europe and other geographies. Dublin, Ireland-based Neuromod won approval to the...

Virtuoso Surgical wins FDA breakthrough device designation for surgical robot

Virtuoso Surgical announced it received FDA breakthrough device designation for bladder lesion removal with its surgical robot. The breakthrough nod covers bladder lesion removal via...

FDA clears Techsomed BioTraceIO360 for kidney ablation

Techsomed announced it received FDA 510(k) clearance to expand indications for its BioTraceIO360 software platform to include percutaneous ablation of soft tissue in the...

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

Jupiter Endovascular announced its Vertex catheter received FDA 510(k) clearance for the insertion of endovascular devices. According to the FDA 510(k) database, the agency received...

Amber Implants wins FDA clearance for VCFix spinal system

Amber Implants received FDA 510(k) clearance for its VCFix Spinal System. The Netherlands-based company designed VCFix to treat vertebral compression fractures. The system is a...

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

Novocuff, Inc., a clinical-stage, maternal health medical device company, today announced approval from the U.S. Food and Drug Administration of its Investigational Device Exemption...

FDA grants approval for Womed Leaf for women with Asherman Syndrome

Womed Leaf Resorbable Adhesion Barrier receives PMA approval for women suffering from moderate to severe intrauterine adhesions, a major cause for female infertility. Womed, the...

Novocure earns Japanese approval for Optune Lua wearable device

Novocure received regulatory approval in Japan for its Optune Lua wearable device. Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Optune Lua for concurrent...
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