Approvals

FDA Grants Clearance for Ortho Clinical’s Chemistry Product Slides

The FDA granted 510(k) clearance for Ortho Clinical Diagnostics’ Vitros XT microslides, a product that couples various tests that physicians usually order together.

The test pairs, which can run simultaneously using the Vitros XT 7600 integrated system, include urea and creatinine, glucose and calcium, and triglycerides and cholesterol.

The microslides enable a higher test throughput without the need for additional or larger analyzers and require smaller blood samples, which is helpful for vulnerable patients and patients with venous access issues.

Avinger’s Image-Guided Atherectomy Device Cleared by FDA

Avinger received 510(k) clearance for its Pantheris SV product, a small vessel image-guided atherectomy system.

The Pantheris SV is an extension of the devicemaker’s Lumivascular image-guided atherectomy platform that is indicated for diagnosing and treating peripheral artery disease in vessels two to four millimeters in diameter.

The device offers improvements like an improved cutter design, a shaft with improved pushability and a superior optical coherence tomography imager.

Nanobiotix’s Nanoparticle Radioenhancer Receives CE Mark

Nanobiotix has earned the CE Mark for its Hensify radioenhancer, an injected nanoparticle device that amplifies the effectiveness of standard radiotherapy.

The device introduces a new mechanism of action that, in combination with radiotherapy, helps to physically eliminate tumors and kick a patient’s immune system into gear for local control and systemic disease treatment.

Hensify is an aqueous suspension of crystalline hafnium oxide nanoparticles that is injected into a tumor after initial radiotherapy treatment.

Insera Gains European Clearance for Stroke Thrombectomy Device

Insera has earned the CE Mark for its CLEAR system, a suction device used for removal of blood clots.

The system is indicated for use in patients with acute ischemic stroke and secondarily for intracranial large vessel occlusive disease. It is also secondarily indicated for removing blood clots from the sinuses.

The CLEAR system can be also be used to remove clots via a guide catheter or balloon guide in the neck arteries.