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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-100/
- Published: 2019-07-21T12:00:00.000Z
- Updated: 2026-09-15T01:39:10.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5131521

**DEVICES**  
  
FDA has approved an **Advance Circulatory Systems** PMA for the ResQCPR System, a two-device system for first responders to use while performing cardiopulmonary resuscitation (CPR) on people in cardiac arrest. The first device, the ResQPump Active Compression Decompression CPR Device, has a double-grip handle that when attached to a patient’s chest with a suction cup allows the rescuer to push for compressions and lift for decompressions, an agency news release says. The second device, the ResQPod 16.0 Impedance Threshold Device, fits onto a rescue face mask or breathing tube to impede airflow into the chest during chest decompression with the ResQPump, reducing the pressure inside the patient’s chest and drawing more blood back to the heart.   
  
FDA has cleared a **Somna Therapeutics** 510(k) for its Reza Band UES Assist Device, which is externally worn and designed to reduce symptoms of laryngopharyngeal reflux by stopping regurgitation of stomach contents through the upper esophageal sphincter. It works by applying slight external pressure to the cricoid cartilage area located below the Adam’s apple, which increases the UES internal pressure.   
  
FDA has cleared a **TomTec Imaging Systems** 510(k) for its innovative TomTec-ArenaTM software suite of clinical applications to review, analyze and quantify medical image data in multiple dimensions (2D, 3D, and 4D) and multiple modalities such as ultrasound and magnetic resonance. The software features a variety of automated solutions for 2D and 3D volume measurements and strain imaging, according to the company.   
  
**Tornier NV** has received FDA 510(k) clearance to market the Simpliciti Shoulder System, a bone sparing total shoulder arthroplasty device designed to treat patients experiencing severe shoulder joint pain, compromised range of motion, loss of strength and functionality.   
  
FDA has cleared **Toshiba America Medical Systems**’ Infinix 4DCT with the Aquilion Prime CT system configuration for oncology and cardiac procedures to deliver real-time CT images during procedures instead of CT-like images. The company says the Infinix 4DCT is a combination of interventional labs and CT technology that utilizes its SUREGuidance technology, which allows for automatic transition between modalities.   
  
**HUMAN DRUGS**   
  
FDA has approved an **Actavis** supplemental NDA for Saphris (asenapine) as monotherapy for the acute treatment of manic or mixed episodes associated with Bipolar 1 disorder in pediatric patients (ages 10–17). The company says the product is the only atypical antipsychotic treatment option with a sublingual formulation.   
  
**United Therapeutics** has received FDA approval of its NDA for Unituxin (dinutuximab) and its use in first-line therapy for pediatric patients with high-risk neuroblastoma, a rare cancer that forms from immature nerve cells. The drug is being approved for use as part of a multimodality regimen, including surgery, chemotherapy and radiation therapy for patients who achieved at least a partial response to prior first-line multiagent, multimodality therapy, an agency release says. The cancer, which occurs in children under five years of age, typically begins in the adrenal glands but may also develop in the abdomen, chest or in nerve tissue near the spine.