FDA clearances, CE mark approvals…

Medtronic received 510(k) clearance of the Accurian RF ablation platform, which conducts radio frequency (RF) ablation of nerve tissues. Surgical RF ablation is a minimally invasive procedure where current produced by radio waves heats up a small area of nerve tissue to stop it from sending pain signals.

Intuitive Surgical’s Ion endoluminal system, enabling minimally invasive biopsy in the peripheral lung, received 510(k) clearance. The Ion system uses an ultra-thin articulating robotic catheter that moves 180° in all directions.

CardioComm Solutions received approval for the over-the-counter (OTC) sales and marketing of the GEMS Mobile smartphone app and HeartCheck CardiBeat, a handheld, heart rhythm monitor.

Cook Medical received approval for its Zenith Dissection Endovascular System, consisting of a proximal stent-graft component and a distal bare stent component, providing physicians a less invasive alternative for open surgery to repair Type B dissections of the descending thoracic aorta.

Zimmer Biomet received clearance for the ROSA One Brain Application, a robotic surgical navigation and positioning system for use in neurosurgical procedures.

Vertos Medical received CE mark approval for its mild device kit, which offers an outpatient, minimally invasive, fluoroscopically guided treatment for lumbar spinal stenosis (LSS).

Sensus Healthcare received market clearance for the Sculptura radiation oncology system that provides cancer patients and physicians a single radiation treatment at the point of surgery.

Altus Partners received 510(k) clearance for its Altus Spine Interbody Fusion System, an intervertebral body fusion device that stabilizes spinal segments and promotes fusion to restrict motion and decrease pain when using a bone graft.

Robocath obtained CE certification for its R-One robotic device that assists interventional cardiologists in stenting (angioplasty).