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Approvals

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Global Device Approvals Snapshot: April 9-15, 2019

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved Qiagen's therascreen FGFR RGQ RT-PCR companion diagnostic for Janssen's new drug to treat specific types of urothelial cancer and Intact Vascular's Tack device to treat dissections of the above-the-knee peripheral arteries following angioplasty.

Research & Development Approvals Innovation
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Gelesis's Plenity Obesity Product Earns De Novo For Wide BMI Range

PureTech's affiliate Gelesis has received US FDA de novo clearance for its Plenity capsule to treat overweight-obese adults, and plans to launch it commercially in the second half.

Approvals Research & Development

Global Device Approvals Snapshot: April 9-15, 2019

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved Qiagen's therascreen FGFR RGQ RT-PCR companion diagnostic for Janssen's new drug to treat specific types of urothelial cancer and Intact Vascular's Tack device to treat dissections of the above-the-knee peripheral arteries following angioplasty.

Research & Development Approvals

Intact Vascular’s Tack Peripheral Dissection Repair Device Earns PMA

The approval of the Intact's peripheral artery dissection repair device is based on results from the 213-patient TOBA II trial, which showed Tack resolved 92.1% of dissections in peripheral arteries following balloon angioplasty.

Research & Development Clinical Trials

FDA Approves Qiagen’s Therascreen Urothelial Cancer Companion Diagnostic

The Therascreen FGFR kit helps identify urothelial tumors with alterations to the fibroblast growth factor receptor 3 gene that indicate the cancer will respond to Janssen’s new drug Balversa.

Research & Development Approvals

FDA Rejects Helius’ De Novo Application For PoNS To Treat Brain Injury

Helius Medical announced on April 10 that the US FDA has declined its de novo application for treating brain injury with its Portable Neuromodulation Stimulator.

Research & Development Approvals

Cost-Effectiveness Studies Support Medtronic's HeartWare HVAD

A cost-effectiveness analysis of the LATERAL trial shows patients treated with Medtronic’s HeartWare HVAD through the less-invasive thoracotomy procedure incurred lower hospitalization and medical supply costs than patients implanted with a ventricular assist device through the traditional sternotomy approach. Another new analysis shows HeartWare HVAD is more cost-effective than ventricular assist devices of the past.

Research & Development Approvals

Global Device Approvals Snapshot: April 2-8, 2019

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.

Research & Development Approvals

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.

Research & Development Approvals

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.

Approvals Research & Development
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