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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-7/
- Published: 2020-04-05T12:00:00.000Z
- Updated: 2026-09-14T16:10:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140062

**DEVICES**

FDA has cleared a **Neusoft Medical Systems** 510(k) for its new 128-slice NeuViz Prime CT scanner. The device features “Spectral Imaging” capabilities to perform image acquisition and processing at multiple energy levels for computed tomography. Neusoft says the scanner also offers 0.259 second rotation speed for high temporal resolution, and it features a new X-Ray tube with a liquid bearing design to improve heat storage and dissipation. “With the new tube, heat is removed faster than it is introduced, eliminating scanning delays,” the company says.

FDA has cleared an **IntraFuse** 510(k) for its FlexThread Fibula Pin System that is intended to provide percutaneous fixation of distal fibula fractures, primarily Danis-Weber B type fractures, or trans-syndesmotic fractures. “Incorporating IntraFuse's proprietary FlexThread technology, the distal end of the implant is a flexible, intramedullary screw and the proximal end is a rigid, high-strength intramedullary rod,” the company says. After being inserted into the fibula, the implant’s rigid rod portion spans and supports the fracture and the flexible screw portion bends as needed to thread into the intramedullary canal, it says.

FDA clears a **Luminex** 510(k) for the ARIES Group A Strep Assay for detecting *Streptococcus pyogenes* from throat swab specimens using the ARIES System*.* The real-time polymerase chain reaction-based qualitative in vitro diagnostic test, is part of Luminex's respiratory testing menu that includes the ARIES *Bordetella* Assay, ARIES Flu A/B & RSV Assay, NxTAG Respiratory Pathogen Panel, and VERIGENE Respiratory Pathogens Flex Test.

**DRUGS**

FDA has approved a **Teligent** ANDA for a generic copy of Promius Pharma’s Sernivo, indicated for treating mild-to-moderate plaque psoriasis in patients 18 years of age or older. Annual sales for betamethasone dipropionate are about $43 million, according to QuintilesIMS Health data.

FDA has approved a **Janssen Pharmaceuticals** supplemental NDA for a 10 mg once-daily dose of Xarelto (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism (VTE) after completing at least six months of initial anticoagulation therapy. The approval is based on data from the EINSTEIN CHOICE clinical study that showed patients taking Xarelto at this 10mg dose had significantly fewer recurrent VTE compared to those taking aspirin.