Approvals

Three Rivers Medical Earns CE Mark for Rio Embolization Coil System

Three Rivers Medical received a CE Mark for its Rio Embolization Coil System. The product includes an embolization coil line and visual detachment system for treatment of cerebral aneurysms and other vascular malformations.

The company plans to begin commercialization through distributors in territories that recognize the CE Mark and is pursuing additional regulatory approvals in key global markets.

FDA Grants EAP Designation to Guardant’s NGS-Based Liquid Biopsy

The FDA granted Guardant Health Expedited Access Pathway designation for its Guardant360 assay, a next-generation sequencing-based liquid biopsy test for advanced cancer.

The assay has been marketed as a laboratory-developed test since 2014 and is available in more than 30 countries. The company plans to submit a PMA to the FDA for the assay by year end.

Pure-Vu System Earns CE Mark

Motus GI secured a CE mark in the European Union for its Pure-Vu system.

The device fits over most standard colonoscopes and allows physicians to clean poorly-prepped colons to improve clinical outcomes. It has already secured 510(k) approval from the FDA and is being piloted in the United States.

The company received CE mark approval based on positive clinical study results it reported last November and it plans to continue post-approval trials over the next year.

Getinge Wins 510(k) Clearance for PulsioFlex Monitoring System

Getinge received FDA 510(k) clearance for its PulsioFlex Monitoring System and PiCCO Module.

The diagnostic aid is used to measure and monitor blood pressure and cardiopulmonary, circulatory and organ function variables in patients in intensive care units.

The PiCCO Module is used for hemodynamic management of critically ill patients, providing cardiac output measurements both continuously and intermittently.

Endomag’s Magseed Marker Cleared for Long-Term and Soft Tissue Implantation

Endomag received 510(k) marketing clearance to extend the indication of its Magseed magnetic marker to include both the marking of soft tissue and long-term implantation. The marker is used to locate lesion for breast cancer.

The device is a wire-free localization device that can be implanted into any soft tissue with no restrictions on the length of time the marker can remain in the body. It is compatible for imaging under ultrasound, X-ray and MRI.

The system is designed to guide the accurate removal of cancer, and to maximize the amount of healthy tissue retained.

Medtronic Wins FDA Nod for Guardian Sensor

The FDA cleared Medtronic‘s Guardian sensor, part of the Medtech’s MiniMed 670G automated insulin delivery system.

The device is a continuous glucose monitor and is used with a hybrid-closed loop system to control insulin delivery.

The system uses Medtronic’s SmartGuard algorithm to automatically adjust insulin delivery every five minutes based on data provided by the Guardian Sensor 3.

Reva Earns CE Mark for Fantom Encore Bioresorbable Scaffold

Reva received a CE mark and reported the first implant of the Fantom Encore bioresorbable scaffold.

Bioresorbable scaffolds were developed as an alternative to metal drug-eluting stents for the treatment of coronary artery disease. The Fantom Encore offers a thin profile without compromising strength or X-ray visibility, using improved polymer processing and manufacturing techniques.

REVA expects to launch the entire Fantom Encore product line later this year.

Siemens Healthineers Receives FDA Clearance for MRI Application

Siemens Healthineers received FDA clearance for GOKnee3D, a magnetic resonance imaging application used for diagnostic exams of the knee.

The device enables a push-button diagnostic 3D knee exam in 10 minutes and high-resolution isotropic 3D images enables flexible evaluation of the images in all planes.