Regulatory Approvals

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...

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Tempus AI’s ECG-Low (ejection fraction) EF software. This software utilises AI to detect...

Synchrony Medical received FDA 510(k) clearance for its LibAirty airway clearance system. LibAirty addresses a need for patients with chronic lung diseases such as chronic...