Approvals

Zimmer Biomet’s 3D Printed Titanium Spinal Implant Receives 510(k) Clearance

The FDA gave 510(k) clearance to Zimmer Biomet’s Zyston Strut open titanium interbody spacer system, a titanium implant manufactured through a 3D printing process.

The system consists of a group of lumbar cages designed to enhance the graft capacity, strength and visualization of interbody spacers in spinal fusion cases, and includes a variety of sizes to work with different patient anatomies and surgical procedures.

The system, available in straight and curved profiles, includes surgical tools to insert, move and remove the implants.

FDA Clears Synedgen’s Wound Hydrogel

Synedgen’s Catasyn advanced technology wound hydrogel was given 510(k) clearance by the FDA for advanced physician administration and over-the-counter use.

Used by patients, the hydrogel can dress and manage minor burns, cuts, lacerations, abrasions and abrasions of the skin.

Under the care of a physician, the hydrogel can be used to treat second degree burns, post-operative sites and partial to full thickness dermal ulcers including pressure sores, arterial ulcers, diabetic ulcers and venous stasis ulcers.

BioGX Launches Six CE-Mark Tests for Antibiotic Resistance and Meningitis

BioGX expanded its BD Max molecular diagnostics platform with six CE Mark diagnosis tests for meningitis and antibiotic resistance.

The six new tests can diagnose viral meningitis HSV/VZV, bacterial meningitis NSH, bacterial meningitis ELGBS, carbapenem resistance KNO, carbapenem/colistin resistance VGM and vancomycin resistance.

With the expansion, the BD Max system now comprises eleven tests, with an additional ten planned for the second half of 2018.

Avinger Gains 510(k) Clearance for Pantheris

Avinger received 510(k) clearance from the FDA for its lumivascular atherectomy system, Pantheris, an image-guided device for treatment of peripheral artery disease.

The system includes a single balloon designed to allow blood flow occlusion and to treat blocked peripheral blood vessels using optical coherence tomography.

An in-process clinical trial is examining the device’s use for treating in-stent restenosis in lower extremity arteries.

Attune Medical Receives 510(k) Clearance for New EnsoETM Models

Attune Medical received 510(k) clearance for new models of its EnsoETM temperature management device to raise or maintain patient temperature with Cincinnati Sub-Zero’s Norm-O-Temp hyperthermia system.

The device manages patient temperature through the esophagus. The clearance includes EnsoETM with ENFit, which allows for enteral fluid administration through the device, and the original EnsoETM.