Approvals

Soterix Medical Gains FDA Clearance for IontoDC System

Soterix Medical has received FDA marketing clearance for its IontoDC electrotherapy device.

The device uses direct current to introduce ions of soluble salts or other drugs into the body and includes controls to adjust the duration and intensity of the treatment.

Stimwave Receives CE Mark Approval for Percutaneous Stimulator Anchoring System

Stimwave Technologies has gained a CE Mark for the Sandshark percutaneous injectable anchor system, used in conjunction with the company’s wireless neurostimulator devices to provide relief of chronic pain. Once the anchor is in the desired location, it secures the stimulator to the surrounding tissue to prevent migration throughout the life of the implant.

Ra Medical Systems Achieves FDA Clearance for Peripheral Artery Disease Treatment

The FDA has granted marketing clearance to Ra Medical Systems for its DABRA System for peripheral artery disease treatment. The single-use catheter produces a lumen while minimizing trauma to the vasculature. The DABRA laser ablates arterial blockages, reducing calcium, thrombus and atheroma, minimizing downstream debris. The portable laser weighs about 100 pounds.

Masimo Wins FDA Clearance of O3 Regional Oximetry for Pediatric Patients

The FDA has granted marketing clearance for Masimo’s pediatric indication for O3 regional oximetry with the O3 pediatric sensor. O3 regional oximetry monitoring, which was already available for adult patients in the United States, is now also available for pediatric patients weighing more than 11 pounds and less than 88 pounds. O3 regional oximetry uses near-infrared spectroscopy to continuously monitor absolute and trended regional tissue oxygen saturation (rSO2) in the cerebral region.

Intuitive Surgical Gets FDA Clearance for Robotic-Assisted Surgical System

Intuitive Surgical has received FDA clearance for its da Vinci X surgical system.

The device features 3D digital optics and flexible port placement. The system enables quadrant surgery including procedures like prostatectomy, partial nephrectomy, benign hysterectomy and sacrocolpopexy.

The device received a CE mark in April. The system will be available for sale in the U.S. later this year.

Atonomics Gains CE Mark for Trace Lipids Test Panel

Atonomics has gained a CE Mark for a lipids test panel on its proprietary Trace platform.

The lipids panel determines total cholesterol, HDL, LDL and triglycerides levels from a blood sample with results generated within minutes.

The cartridge test can be used to monitor the effectiveness of diet, lifestyle changes and medication to lower cholesterol.

The device is linked to an app that provides a read-out and tracking.