Approvals

Axonics’ Sacral Neuromodulation System Gains Further Clearance

Axonics received the CE Mark for full-body MRI conditional labeling for its sacral neuromodulation device, used to treat urinary and bowel dysfunction.

The device is the only implantable sacral neuromodulation device that has received full-body MRI conditional labeling for European marketing.

With the clearance, patients receiving an MRI scan anywhere below the head no longer need to have their neurostimulator explanted before they undergo the scan.

Axilum Cleared by FDA for TMS-Cobot TS MV

The FDA granted 510(k) clearance to Axilum Robotics’ TMS-Cobot, a device that helps position and orient the MagVenture TMS therapy system.

The TMS-Cobot includes a proprietary optical tracking system that enables the user to control, in real-time, the MagVenture’s position, orientation and contact. The device can also compensate for patient head movement.

The MagVenture, which delivers transcranial magnetic stimulation, has been cleared by the FDA for the treatment of major depressive disorder in patients who have not seen satisfactory improvement from antidepressant drugs.

iVascular’s Microcatheter Gains CE Mark

iVascular’s Navitian coronary microcatheter received a CE Mark for supporting and handling a guidewire during the treatment of chronic total occlusions (CTOs).

The device is cleared to help navigate guidewires in the case of a near-to-complete blockage of a coronal artery. It is also approved to exchange guidewires and inject radiopaque contrast media or saline solutions.

The microcatheter’s braided pattern improves its flexibility and resistance to kinking, and its hydrophilic coating allows for high trackability in small, complex arteries.

Edwards Lifesciences Gains CE Mark for Mitral Repair Device

Edwards Lifescience gained the CE Mark for its Pascal transcatheter valve repair system for treating mitral regurgitation, the leakage of blood back through the mitral valve.

The device is designed to reduce mitral regurgitation, caused when the heart’s left ventricle contracts and the valve fails to close tightly.

The system uses two contoured, broad paddles to pull the valve’s two leaflets together, as well as a central spacer to fill the regurgitant orifice area.

FDA Clears Soft Tissue Visualization Addon for MRIdian SmartVision

The FDA granted 510(k) clearance for ViewRay’s MRIdian SmartVision system, giving the go-ahead for the device’s new soft tissue visualization capabilities.

The addon for the SmartVision MRI — which allows for high-definition imaging while removing risks of skin toxicities — gives enhanced contrast between different tissues to help clinicians with tissue visualization.

The new clearance enables the system to give faster, brighter and more detailed imaging for more precise targeting of tumors.

Abbott’s HBV Surface Antigen Test Earns CE Mark

Abbott has been handed the CE Mark for its Determine HBsAg2 diagnostic test, a device used for detecting hepatitis B surface antigens in a patient’s blood.

The portable diagnostic test — which provides results in 15 minutes — can be used with ease in any healthcare setting and has an analytical sensitivity of 0.1 IU/ml.

Patients can provide blood, plasma or serum for the diagnostic test to determine if they are infected with the virus and require treatment.

NuVasive’s Magnetic Implant System Nabs Dual Clearance

NuVasive’s Precice bone transport system has received both 510(k) clearance and the CE Mark for use in segmental bone loss treatment.

The Precice system is part of the company’s NuVasive Specialized Orthopedics family of magnetically adjustable, limb-lengthening implants.

The magnetic implant can treat complex segmental defects in the tibia and femur caused by trauma or infection and allows patients to avoid many complications from external fixation systems.