Regulatory Approvals

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...

Ciliatech announced it received CE mark approval for its Intercil uveal spacer, an eye implant for treating glaucoma. The Chavanod, France-based company labeled Intercil as...

Brightonix Imaging announced its flagship Pharos positron emission tomography (PET) scanner received FDA clearance. Pharos, a state-of-the-art clinical PET system, offers high-quality imaging as part...