Regulatory Approvals

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,...

Stereotaxis has received US Food and Drug Administration (FDA) clearance for MAGiC Sweep, an electrophysiology (EP) catheter. Shares in the company rose by 10.66% from...

CARMAT, designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular...

Imperative Care received FDA 510(k) clearance for its novel Zoom 7X catheter for aspiration thrombectomy procedures. The company also reported the first patient cases with...

Elekta announced it received FDA 510(k) clearance to expand indications for its Leksell Gamma Knife radiosurgery system. The system’s cleared indications now include refractory, intractable...

Spirair announced the FDA granted 510(k) clearance for its TurbAlign bioabsorbable implant device. The company designed the novel, bioabsorbable device to aid healing from sinus...

UroMems is set to enter the pivotal trial phase with its device for treating stress urinary incontinence (SUI). The company was awarded an investigational device...