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Global Device Approvals Snapshot: April 2-8, 2019

Executive Summary

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved TherOx’s Supersaturated Oxygen System. PharmaEngine/Nanobiotix said its Hensify NBTXR3 nano-particles received the CE mark and plans to market it in 27 European countries for treating locally advanced soft tissue sarcoma.

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Nanobiotix's Hensify Earns CE Mark For Soft-Tissue Sarcoma

The CE mark will make Hensify nanoparticle radioenhancers available in 27 European countries. Hensify is the brand name for NBTXR3, an aqueous suspension of crystalline hafnium oxide nanoparticles, approved specifically for treating locally advanced soft-tissue sarcoma.

FDA Approves TherOx’s SuperSaturated Oxygen Heart Attack Therapy

Clinical trials have shown that SuperSaturated Oxygen Therapy (SSO2 Therapy) reduces the size of myocardial infarcts in the regions of the heart-muscle perfused by the patient’s left anterior descending coronary artery immediately following stenting.

Medtronic, The Foundry Invest In New Transcatheter Mitral Repair Technology

The deal gives Medtronic the exclusive right to acquire Half Moon Medical, a start-up developing a mitral valve repair system to compete with Abbott’s MitraClip.

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