Regulatory Approvals

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 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...

AngioSafe announced it has received FDA 510(k) clearance and CE marking for its Santreva-ATK endovascular revascularization catheter. San Jose, California-based AngioSafe designed the device for...

The US Food and Drug Administration (FDA) has granted de novo classification to Biolinq Shine, a wearable biosensor that would be the first needle-free...

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

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 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...