Regulatory Approvals

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...

NeuroOne Medical Technologies has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its OneRF trigeminal nerve ablation system to treat...

Onward Medical announced it received FDA investigational device exemption (IDE) for its ARC-IM system. ARC-IM, an implanted neuromodulation platform, delivers targeted and personalized spinal cord...

The FDA has granted breakthrough device designation to SpinaFX Medical’s Triojection system, a minimally invasive treatment for contained lumbar disc herniations. Triojection is an image-guided...

DeepSight Technology announced it received FDA 510(k) clearance for its NeedleVue LC1 ultrasound system. The company said clearance marks an important step forward in the...

Myra Vision announced that it received FDA investigational device exemption (IDE) approval for its Calibreye system. The Shifamed portfolio company can now initiate its ADAPT...

Instylla received FDA premarket approval (PMA) for its flagship Embrace hydrogel embolic system (HES). The Bedford, Massachusetts-based company received approval for Embrace for the embolization...

Nyxoah received FDA approval for its Genio neuromodulation device for treating sleep apnea. Genio utilises an implanted electrode around the hypoglossal nerve, stimulating the tongue...