Regulatory Approvals

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...

Pulsecare Medical announced that Chinese regulatory authorities granted marketing approval for its pulsed field ablation technology. Shenzhen, China–based Pulsecare develops the NxPFA nanosecond PFA system....

SetPoint Medical announced the FDA approved its SetPoint neuroimmune modulation system for treating rheumatoid arthritis (RA). The first-of-its-kind device treats adults with moderate-to-severe RA not...

A new style of hip implant from Embody Orthopaedic that enables women to have a type of hip surgery previously only suitable for men,...