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Global Device Approvals Snapshot: April 9-15, 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 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.

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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.

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.

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.

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