Regulatory Approvals

inTRAvent Medical Partners LP, a medical device company dedicated to bringing intra-operative imaging and navigation to the bedside to improve neurosurgical procedures, today announced...

Varian announced its Embozene microspheres have received CE mark for genicular artery embolisation (GAE) to treat knee osteoarthritis. The regulatory clearance makes Embozene the first...

Danish medtech company Neurescue has gained a European CE mark for its catheter to address non-shockable cardiac arrest. The company’s catheter is used in conjunction...

The US Food and Drug Administration (FDA) has cleared Microbot Medical’s LIBERTY, a single-use, remotely operated robotic system for peripheral endovascular procedures. Microbot completed the...

Lifeward (Nasdaq:LFWD) received CE mark approval for its ReWalk 7 personal exoskeleton. ReWalk 7, the seventh generation of the company’s personal exoskeleton, includes a number...

ClearPoint Neuro, a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced that the ClearPoint Prism...

Surgerii Robotics announced on LinkedIn that its Shurui single-port surgical robot garnered CE mark approval in Europe. According to the company’s post, it marks the...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to 4DMedical’s non-contrast, computed tomography (CT)-based ventilation-perfusion imaging technology, CT:VQ, for respiratory diagnostics. This...

Airiver Medical announced it received FDA investigational device exemption (IDE) for its pulmonary drug-coated balloon (DCB). The Brooklyn Park, Minnesota-based company designed its DCB to...